Phadia 250 User Manual V 1 4 en

Phadia 250 User Manual
Version information
Phadia 250 User Manual, version 1.4
This version is valid for:

Phadia 250 Instrument Software v 2.3
Issued April 2010

Revised November 2012
Information in this document is subject to changes without notice. All pictures displayed
in this manual should be regarded as examples only.
Contents
General Information.....................................................................................................10
Trademark Change...........................................................................................................................10
About this Manual...........................................................................................................................10
Version Information.............................................................................................................10
Phadia IDM......................................................................................................................................10
Intended Use........................................................................................................................10
Principal Functionality........................................................................................................11
Operator Requirements........................................................................................................11
Phadia 250.......................................................................................................................................11
Intended Use........................................................................................................................11
Principal Functionality........................................................................................................11
Operator Requirements........................................................................................................12
Good Laboratory Practice....................................................................................................12
SuperUser Information........................................................................................................12
Solid Phase..........................................................................................................................12
Operational Precautions.......................................................................................................13
Safety...............................................................................................................................................13
Warnings..............................................................................................................................13
Mechanical Safety...............................................................................................................16
Biochemical Safety..............................................................................................................17
Electrical Safety...................................................................................................................18
Waste Management of Instruments.................................................................................................20
Manufacturer Information...............................................................................................................20
Phadia AB............................................................................................................................21
Market Companies/Distributors..........................................................................................21
Copyright and Trademarks..............................................................................................................24
Patents..................................................................................................................................24
Copyright.............................................................................................................................24
Trademarks..........................................................................................................................24
Glossary...........................................................................................................................................24
Terminology.........................................................................................................................25
Acronyms and Abbreviations..............................................................................................31
System Configuration....................................................................................................32
Phadia IDM Setup...........................................................................................................................32
Installation and Upgrade......................................................................................................32
Useful Preferences and Settings..........................................................................................32
Important System Parameters..............................................................................................36
Phadia 250 Settings.........................................................................................................................38
Parameter Settings...............................................................................................................38
Regional Settings.................................................................................................................41
Barcode Settings..................................................................................................................44
Tube Settings.......................................................................................................................45
Miscellaneous Settings........................................................................................................56
Errors/Warnings Settings ....................................................................................................63
Basic Configuration Settings...............................................................................................64
Module Settings...................................................................................................................64
Verification of Instrument Performance..........................................................................................65
Calculation of CV % Values................................................................................................65
ImmunoCAP Specific IgE...................................................................................................66
ImmunoCAP Specific IgE 0-100.........................................................................................67
ImmunoCAP Total IgE........................................................................................................69
ImmunoCAP ECP and ImmunoCAP Tryptase....................................................................70
ImmunoCAP Specific IgG...................................................................................................71
ImmunoCAP Specific IgG4.................................................................................................72
EliA IgG, EliA IgA and EliA IgM......................................................................................73
Calculation Model...............................................................................................................74
System Description........................................................................................................78
ImmunoCAP and EliA Description.................................................................................................78
ImmunoCAP Technology....................................................................................................78
EliA Technology..................................................................................................................93
ImmunoCAP/EliA Reagents..............................................................................................103
Phadia 250 System.........................................................................................................................107
System Computer Specifications.......................................................................................107
Phadia Information Data Manager (IDM).........................................................................107
Phadia 250 Specification...................................................................................................118
Phadia 250 Instrument Description...................................................................................123
Phadia 250 Instrument Software....................................................................................................151
Instrument Screens............................................................................................................152
Maintenance Programs......................................................................................................202
ISW Parameter Setting......................................................................................................229
Operation.....................................................................................................................258
Start Up - Shut Down....................................................................................................................258
Phadia IDM........................................................................................................................258
Phadia 250.........................................................................................................................259
Routine Operation..........................................................................................................................260
Start Up..............................................................................................................................261
Check Request...................................................................................................................262
Check Inventory................................................................................................................262
Load Reagents...................................................................................................................263
Start Assay.........................................................................................................................264
Load Samples....................................................................................................................270
End Assay..........................................................................................................................272
Manage Results..................................................................................................................275
Request Management....................................................................................................................277
Sample Tube Type.............................................................................................................278
Import Requests.................................................................................................................278
Enter Request Manually....................................................................................................279
Enter Request using a Barcode Reader (IDM) .................................................................280
View Request.....................................................................................................................280
Instructions for reflex testing.............................................................................................281
Disable/Exclude test..........................................................................................................283
Export Requests Manually.................................................................................................284
Reset Request Status..........................................................................................................284
Sample Management.....................................................................................................................285
About Sample management...............................................................................................285
Define Sample Rack .........................................................................................................285
Configure Sample Rack.....................................................................................................286
Sample and Rack Handling...............................................................................................288
Load Sample Tubes...........................................................................................................289
Reagent Management....................................................................................................................294
Print Loadlist.....................................................................................................................294
On board Stability..............................................................................................................295
Load Reagents...................................................................................................................296
Unload/Empty....................................................................................................................305
Quality Control Management........................................................................................................308
Entering QC data in IDM..................................................................................................308
Define QC Rack.................................................................................................................311
Load Quality Control Vials................................................................................................312
Load QC Racks..................................................................................................................312
Quality Control Information in IDM.................................................................................312
Manage Quality Club Samples in IDM.............................................................................313
Result Management.......................................................................................................................318
Approve Run......................................................................................................................318
Approve Results................................................................................................................319
Reject Results....................................................................................................................320
Export Results....................................................................................................................321
Print Results.......................................................................................................................321
Calibration and Acceptance...............................................................................................321
Acceptance Rules..............................................................................................................324
Process Monitoring........................................................................................................................329
Overview of the Assay Run...............................................................................................329
Check Temperatures in Phadia 250...................................................................................332
Unscheduled Operation.................................................................................................................332
Initialization.......................................................................................................................332
Handle Expiration Date.....................................................................................................332
Add Extra Calibrator/CC...................................................................................................333
Pause Current Process.......................................................................................................334
Abort Current Process.......................................................................................................334
Registered Loading Trays..................................................................................................334
Load Conjugate Tray.........................................................................................................341
Load Strip Tray..................................................................................................................342
Load Missing Carrier.........................................................................................................342
Set Usage Frequency.........................................................................................................344
Move Sample Rack Content..............................................................................................344
Multiple Rack Selection....................................................................................................345
Filter Rack List .................................................................................................................346
Loading Reagents During an Assay Run...........................................................................347
Replace Carrier Storage Tray............................................................................................358
Wash Volume Check..........................................................................................................360
Mixed Technologies...........................................................................................................361
Quality Guide...............................................................................................................363
Introduction...................................................................................................................................363
Quality Assurance..........................................................................................................................363
Basic Concepts..............................................................................................................................364
Measurements....................................................................................................................364
Basic Statistics...................................................................................................................364
Variation in Results............................................................................................................365
Accuracy and Precision.....................................................................................................366
Quality Controls............................................................................................................................367
Handle ImmunoCAP Quality Controls..............................................................................368
Handle EliA Quality Controls...........................................................................................369
Quality Control Targets and Limits...................................................................................369
Quality Control Charts...................................................................................................................369
External Quality Assessment.........................................................................................................370
Quality Club......................................................................................................................370
Expected Results............................................................................................................................376
Quality Costs.................................................................................................................................377
Maintenance.................................................................................................................378
Daily Maintenance.........................................................................................................................379
Daily Rinse........................................................................................................................379
Surface Cleaning................................................................................................................380
Reboot of the Instrument ..................................................................................................380
Weekly Maintenance.....................................................................................................................380
Weekly Rinse.....................................................................................................................381
Cleaning of Wash, Rinse and Waste Bottles......................................................................382
Reboot of the Instrument...................................................................................................382
Monthly Maintenance....................................................................................................................382
Monthly Maintenance Procedure.......................................................................................383
Additional actions after using Sodium Hypochlorite as Cleaning Solution......................385
Cleaning of Wash, Rinse and Waste bottles......................................................................386
Lubrication of O-rings.......................................................................................................386
Clean ImmunoCAP Transfer and Ejection Tool................................................................386
Clean Sample Racks..........................................................................................................386
Reboot of the Instrument...................................................................................................387
Unscheduled Maintenance.............................................................................................................387
Test Functions....................................................................................................................387
Prime..................................................................................................................................388
Blank Measurement...........................................................................................................388
Initialize.............................................................................................................................389
FluoroC Measurement.......................................................................................................389
Wash Volume Check..........................................................................................................389
Verify Carrier Storage........................................................................................................391
Eject ImmunoCAP / EliA Well..........................................................................................391
Carrier Transfer between Storage Trays............................................................................391
Troubleshooting...........................................................................................................393
How to Avoid Problems.................................................................................................................393
Placement/environment.....................................................................................................393
Reagent handling...............................................................................................................393
Evaporation........................................................................................................................395
Pooling...............................................................................................................................395
Securing reagent volumes..................................................................................................395
Sample Handling...............................................................................................................395
The importance of maintenance.........................................................................................396
Most common issues.........................................................................................................396
The importance of following the instructions in the manual.............................................396
Deviation.......................................................................................................................................397
QC......................................................................................................................................397
Cal/CC...............................................................................................................................397
IDM Messages...............................................................................................................................397
Calibration Curve Not OK ................................................................................................398
Calibration Curve Partly Not OK......................................................................................400
Curve Controls Not OK.....................................................................................................401
Curve Controls Partly Not OK .........................................................................................403
Re-measured Curve Controls Not OK...............................................................................404
Instrument Alerts...........................................................................................................................406
Alert Display......................................................................................................................406
Attention Light..................................................................................................................408
0-Type Alerts.....................................................................................................................409
1-Type Alerts.....................................................................................................................409
2-Type Alerts.....................................................................................................................409
3-Type Alerts.....................................................................................................................409
4-Type Alerts.....................................................................................................................409
Power Failure.....................................................................................................................409
General Information
Trademark Change
Phadia AB has changed the trademarks of the instrument platforms from "UniCAP" and
"ImmunoCAP" to "Phadia". The new name is being applied to the instruments and related
items, e.g. Software and User Manuals. The trademark "ImmunoCAP" has been removed from
the System Reagents. This is a trademark change only; the change has no impact on performance
or safety.
About this Manual

This user manual describes how to handle the Phadia instrument. Further information about the
various reagent products is found in the Directions for Use and further information about the
Phadia IDM software is found in the IDM Reference guide.
This User Manual is not country specific and therefore reference may be made to methods and/or
assays that are not registered or cleared for use in a specific country. Please consult your local
Phadia representative for country specific information regarding the regulatory status or particular
assays or methods on the Phadia instrument. All pictures displayed in this manual should be
regarded as examples only.
Version Information
Phadia 250 User Manual, version 1.4
This version is valid for: Phadia 250 Instrument Software v 2.3
Issued April 2010, revised November 2012.
Phadia IDM
Intended Use
Phadia Information Data Manager (IDM) is a software to be used together with Phadia instruments
in clinical laboratories. The software handles requests, results, calculations and statistics for
dedicated in vitro diagnostic tests. The software can be used for communication with other
dedicated systems in clinical laboratories.
Principal Functionality
Phadia Information Data Manager (IDM) is a PC software running under the Microsoft Windows
operating system. It handles requests, results, calculations and statistics for Phadia instruments.
For Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000, the software is necessary for
operation, and for Phadia 100 it is optional. Up to 5 Phadia 100, 250 and 1000 instruments, of
the same or different type, can be connected to one single IDM. Phadia 2500 and 5000 needs a
dedicated IDM, i.e. only one instrument per IDM can be connected.
IDM handles communication with other laboratory systems such as LIS (Laboratory Information
System) and LAS (Laboratory Automation System). It can also be connected to the instrument
DSX from Dynex, for request download and result retrieval. IDM can be connected to Phadia
LabCommunity software for remote control, troubleshooting and support of IDM and connected
Phadia instruments.
Operator Requirements
Phadia Information Data Manager (IDM) includes an integrated user manual with all necessary
information. However, operators are required to attend training in operating the software.
Phadia 250
Intended Use
Phadia 250 is a fully automated instrument including software to be used together with dedicated
in vitro diagnostic tests and the software Phadia Information Data Manager (IDM). The instrument
is designed to handle processing of samples and reagents. Phadia 250 is intended to be used in
clinical laboratories.
Principal Functionality
Phadia 250 is designed to be used together with ImmunoCAP and EliA in vitro diagnostic tests
manufactured by Phadia AB. Phadia 250 yields the same analytical results from samples of the
same specimen as Phadia 100, Phadia 1000, Phadia 2500 and Phadia 5000 within stated tolerance
limits. The instrument is fully automated with continuous random access capability, i.e. continuous
loading of samples to be tested with random selection of predefined tests.
The instrument includes functions for:
Distribution of samples, ImmunoCAP and EliA wells, and reagents.
Processing of all assay steps for incubation and washing, and reading of measuring values.
Measuring values are electronically transferred to Phadia Information Data Manager (IDM),
which includes functions for calculations to analytical results, calculation of statistics and result
reporting. Phadia 250 is designed to handle approximately 250 tests per working day.
Operator Requirements
Phadia 250 User Manual contains all information needed to operate the instrument. However,
operators are required to attend training in operating the instrument.
Good Laboratory Practice

Laboratories using Phadia instruments and software are expected to have routines according to
Good Laboratory Practice (GLP).
SuperUser Information
To access certain parts of the instrument software (ISW) and IDM, the user must log in to a
higher user level. To be granted access to the SuperUser level, the operator must first attend
special SuperUser training provided by Phadia.
Solid Phase
ImmunoCAP
ImmunoCAP are flexible hydrophilic polymer carrier encased in a
capsule. The carrier consists of an activated cellulose derivative.
Allergen ImmunoCAP Carriers, each containing 16 or 10 ImmunoCAP
are separately available to permit individual selection of the most
suitable allergen panel. When handling ImmunoCAP, keep the
ImmunoCAP Carrier closed to avoid evaporation of buffer. Do not
leave the carrier open for more than 1 day at room temperature.
Otherwise, discard the first ImmunoCAP.
EliA Well
EliA Wells are polystyrene wells coated with antigens or antibodies.
12 EliA Wells are packed per EliA Well Carrier together with a
desiccant. The EliA Well Carriers are stored in sealed aluminum foil
bags with desiccant. EliA Wells are moisture sensitive, the bag must
be properly resealed. Prior to opening the foil bag, equilibrate to room
temperature.
Due to the moisture sensitivity of EliA Wells the storage lifetime of
the EliA Wells that are loaded into the instrument storage
compartment is limited. The relevant expiry date is automatically
displayed by the instrument.
Operational Precautions
Phadia 250 is intended for in vitro diagnostic use. Testing is performed using ImmunoCAP/EliA
reagents only. When operating Phadia 250, reagents manufactured from human blood components
are frequently used. The source materials have been tested by immunoassay for hepatitis B surface
antigen, for antibodies to HIV 1, HIV 2 and hepatitis C virus and found to be negative.
Nevertheless, all recommended precautions for the handling of blood derivatives should be
observed. Please refer to Human Health Service (HHS) Publication No. (CDC) 93-8395 or other
local/national guidelines on laboratory safety procedures.
Safety
If this equipment is used in a manner not specified by the manufacturer, the protection provided
by the equipment may be impaired.
When operating Phadia instruments, reagents manufactured from human blood components are
frequently used. The source materials have been tested by immunoassay for hepatitis B surface
antigen, for antibodies to HIV 1, HIV 2 and hepatitis C virus and found to be negative.
Nevertheless, all recommended precautions for the handling of blood derivatives should be
observed. Please refer to Human Health Service (HHS) Publication No. (CDC) 93-8395 or other
local/national guidelines on laboratory safety procedures.
All service and maintenance, except for the procedures described in the Maintenance chapter in
this manual, must be performed by an authorized Phadia service technician.
Warnings
This section describes the general precautions and precautions regarding laser safety. The warning
labels that are attached to the instrument are also illustrated.
Warning!
This notice calls attention to the possibility of damage to software, operator, devices, or equipment.
The following warning statements are issued in this manual.
Warning! Potential electrical hazards exist behind the side, the front and the back panel
of the system. Keep covers and safety shields closed during normal operation
for your own protection and to maintain system temperature.
Warning! Do not operate the system if any of the subsystems has been removed.
Removing subsystems from their normal positions may cause electrical
hazards.
Warning! Do not use radio transmitters or mobile telephones within a radius of 2 meters
from Phadia 250. The use of such devices close to the instrument may impair
the instrument's performance.
Warning! Phadia 250 waste container collects liquid waste containing human body
fluids, which might be infected. When emptying and cleaning the waste
container take precautions to avoid direct contact with the liquids. Use gloves!
Warning! Do not remove a waste container that is in use.
Warning! Take precautions to avoid direct contact with parts that have been in contact
with samples. Use gloves!
Warning! All recommended precautions for handling of blood derivatives should be
observed. Please refer to Human Health Service (HHS) Publication No.
(CDC) 93-8395 or other local/national guidelines on laboratory safety
procedures.
Warning! The sample pipette, which carries human body liquids, may move without
warning. There is a risk of skin damage. Keep your hands out of pipetting
range.
Warning! The robot arms, which carry human body liquids, may move without warning.
There is a risk of skin damage. Please, keep your hands out of the robot arms
ranges.
Warning! It is recommended to use safety goggles during operation of the system.
Warning Labels
A warning label kit is shipped with the instrument. The appropriate language version of the
warning labels shall be applied by the Phadia representative during the installation of the
instrument.
The following warning labels are attached to the Phadia 250:
Three copies of the biohazard warning label are applied to
the instrument:
One on the Fluid Waste Container
One close to the Sample Loading Area
One on the shelf underneath the Solid Waste Container
This warning label is located between the Operators Panel

and the ImmunoCAP / EliA well Carrier Storage.
This warning label is located close to the Barcode

Reader slot, on the right side of the Sample Loading
Area. In the United States another label is used (see
below).
This label should only be used in the United States

according to FDA regulations. Location: Same as
above.
Laser Safety Considerations

The visible semiconductor laser is used as the light source. The properties of the semiconductor
laser in Phadia 250 are:
Model BL 700
Wave length 650 nm
Max. output 1.4 mW
Pulse width 91 s
Class CLASS II LASER PRODUCT
Make sure to follow these precautions when handling the laser in the instrument:
Warning! Danger exists with the laser used for the unit. Therefore, never operate, adjust
or use the unit in ways other than those instructed in this manual. If
excessively exposed to the laser beam, your eyes and skin may be damaged.
Warning! To protect your eyes, avoid directly looking at the laser beam or at the beam
if reflected from a mirror. Although the laser does not affect your skin, avoid
directing the laser beam to the human body.
Warning! Never attempt to disassemble the unit as it does not contain a mechanism
for stopping radiation of laser beam during disassembly. If you disassemble
the unit, you may be adversely affected by the laser beam.
Warning! It is recommended that the system is isolated by a fence so that a third person
will not be near the system during operation.
Mechanical Safety
European Directives and Standards

Phadia 250 complies with the following European Directive:
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In
Vitro Diagnostic Medical Devices
Note:
The compliance with the above European Directive is valid only when Phadia 250 is installed,
operated and maintained in accordance with the conditions stated in the user manual. In order to
maintain compliance, only methods and spare parts approved or supplied by Phadia or your local
Phadia representative shall be used in maintenance and service of Phadia 250.
Any change or modification in the procedure not recommended by Phadia AB may affect the
results, in which Phadia AB disclaims all warranties expressed, implied or statutory, including
the implied warranty of merchantability and fitness for use.
Phadia AB and its authorized distributors, in such event, shall not be liable for damages indirect
or consequential.
Biochemical Safety
Maintenance
It is important that the Phadia instrument is maintained according to the instructions in the
Maintenance chapter. Daily and weekly maintenance is of special importance.
Risk of Infection
The Phadia instrument processes human body fluids that might be infected. When servicing and
maintaining the Phadia instrument take precautions to avoid direct contact with parts that have
been in contact with samples. Use gloves. Contagious material that is in the blood serum and
plasma can be transferred to a person in three different ways:
By Inoculation, i.e., by puncture of skin by sharp infected object (e.g. pipette tip) that deposits
serum and/or plasma underneath the skin.
By direct contact on wounded skin or skin affected by eczema.
By airborne particles into the mucous membranes, e.g. in the mouth or in the eyes.
Serum, plasma or airborne particles onto healthy skin are not dangerous, but can easily by accident
be transferred into eyes, mouth or onto wounded skin from there.
Which Diseases?
There are a lot of different contagious material represented by bacteria, parasites, and viruses.
The three most important are:
Hepatitis B Virus. The most contagious of the actual viruses. The risk to get a chronic disease
is approx 5 %. It exists everywhere in the world.
Hepatitis C Virus. Gives Hepatitis C. The risk of developing a chronic disease is as high as 60
to 90 %. It exists everywhere in the world.
Human Immunodeficiency Virus, HIV. Gives in most cases a chronic infection that in its last
stage is called AIDS (Acquired Immunodeficiency Syndrome). It exists everywhere in the world.
Probability of Infection
The risk of being infected is always higher by inoculation than in direct contact or by airborne
particles. Hepatitis B is the most contagious of the three, followed by Hepatitis C. HIV is the
least contagious.
Hepatitis B Virus. In inoculation with blood (serum and plasma) from a highly contagious person
the probability can be as high as 30 %. The risk in direct contact or by airborne particles is
unknown. Hepatitis B Virus is active a long time outside the body, also in dried blood (serum
and plasma).
Hepatitis C Virus. By inoculation the probability is in the range of 2 to 5 %. The risk in direct
contact or by airborne particles is unknown.
HIV. The probability depends very much on which stage the infected person is. By inoculation
the probability is in the range of 0.2 to 0.4 %. The risk in direct contact or by airborne particles
is considerably lower. The lifetime of HIV outside the body is short.
How to Avoid Getting Infected
Prevention
The Phadia instruments can be infected in various areas. Pipettes and parts that come in direct
contact with the serum and plasma are high risk areas. The waste always contains serum and
plasma to some extent, and the transport tubings for the waste will also have been in contact with
it.
Spillage of serum and plasma can occur everywhere.
Use Gloves. It is a cheap life insurance to use a pair of disposable latex gloves. Throw the gloves
away afterwards in a container for contagious waste.
Wash your hands. Avoid putting your hands into the mouth, eyes etc. Do not eat, drink coffee,
smoke before you have washed carefully.
What to do after Serum and Plasma Contact

If, despite all precautions, you get serum and/or plasma onto your skin or in your mucous
membranes, wash with soap (if possible) and water as soon as possible. Use an abundance of
water. Disinfect with 70 % ethanol where it is possible. If you have got it in your eyes use an
eye shower.
If there is an obvious risk that you have been contaminated, contact a doctor for further advice
and action.
Phadia 250
Areas of Concern
Sample tubes in the sample racks contain serum, plasma and human stool. The sample racks are
loaded into the sample loading area in the working area. There is a risk of spillage everywhere
in the working area.
During processing, serum, plasma and human stool is aspirated by the sample pipette from the
sample tubes and pipetted into the ImmunoCAP/EliA Well in the Incubation Carousel. Handle
the waste with care.
The liquid waste is collected in the Fluid Waste Container. Handle the waste with care.
Electrical Safety
Mains Power Supply (AC)

Electrical specifications includes mains power, frequency, consumption, fuses and power failure.
Note:
The Phadia 250 instrument must be installed by a Phadia service engineer, and in accordance
with the installation guide and local regulations.
Electrical Safety Classification

Type of protection: Class I.
Must only be connected to an earthed outlet
European Standards
The electrical safety properties of Phadia 250 complies with requirements in the European
standards:
EN 61010-1 second edition (2001) "Safety requirements for electrical equipment for
measurement, control and laboratory use".
EN 61010-2-101 ed. 1 (Particular requirements for In Vitro Diagnostic (IVD) medical
equipment).
EN 61010-2-081 ed. 1 (Particular requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes).
Other Standards
The electrical safety properties of the Phadia instrument also complies with the electrical safety
standards used in the US and Canada:
UL-61010A-1 and CAN/CSA-C22.2 No. 1010.1
A label is placed on the instrument:
Electromagnetic Compatibility
Phadia 250 complies with the following European standards:
EN 61000-6-2 (2001). "Electromagnetic Compatibility, Part 6:2: Generic standards, Immunity
for industrial environment".
EN 61000-6-3 (2001). "Electromagnetic Compatibility, Part 6:3: Emission standard for residential,
commercial and light-industrial environments.
EN 61326, with amendment A1 1998 (Immunity test requirements for equipment intended for
use in industrial locations and industrial environments)
Note:
The compliance with the above European standards is valid only when Phadia 250 is installed,
operated and maintained in accordance with the conditions stated in the user manual. In order to
maintain compliance, only methods and spare parts approved or supplied by Phadia or your local
Phadia representative shall be used in maintenance and service of Phadia 250.
Any change or modification to the procedure not recommended by Phadia AB may affect the
results, in which Phadia AB disclaims all warranties expressed, implied or statutory, including
the implied warranty of merchantability and fitness for use.
Phadia AB and its authorized distributors, in such event, shall not be liable for damages indirect
or consequential.
Waste Management of Instruments

Due to environmental reasons, decommissioned Phadia instruments must be taken care of in a
controlled way and in accordance with national regulations. Within EU countries and in
Switzerland and Norway this is done according to Directive 2002/96/EC of the European
Parliament and of the Council of 27 January 2003 on electrical and electronic equipment
(WEEE)
In general, Phadia uses an individual system which means that decommissioned Phadia instruments
are sent back to Phadia AB in Uppsala. However, local deviation may occur. For disposal of the
instrument, please contact your local Phadia representative or Phadia AB.
To ensure the minimizing of disposal of Waste from Electrical and

Electronic Equipment (WEEE), this label is placed on the Rear Panel
of the instruments, according to the standard EN 50419, "Marking of
electrical and electronic equipment in accordance with Article 11(2)
of Directive 2002/96/EC (WEEE)". (This applies within EU countries,
Switzerland and Norway since August 2005.)
Manufacturer Information
Find information about the manufacturing head quarter and all market companies/distributors
below.
Phadia AB
The Phadia system is manufactured by:
Phadia AB
Rapsgatan 7P
P. O. Box 6460
751 37 UPPSALA
Sweden
Tel: +46 18 16 50 00
Fax: +46 18 14 03 58
e-mail: info-ua.idd@thermofisher.com
Market Companies/Distributors
Addresses
AUSTRIA Phadia Austria GmbH
Donau-City-Strae 1
1220 Wien
Tel: +43-1 270 2020 Fax: +43-1 270 202020
BELGIUM Phadia NV/SA
Pontbeekstraat 2
Rue de la Fuse, 64
BE-1702 GROOT-BIJGAARDEN
Tel: +32-2 749 55 15 Fax: +32-2 749 55 23
BRAZIL Phadia Diagnsticos Ltda.
Rua Luigi Galvani, 70-10 andar - conj. 101
Cidade Mones - So Paulo SP
Cep: 04575-020
Tel: +55-11 3345 5050 Fax: +55-11 3345 5060
CHINA Beijing Phadia Diagnostics Co., Ltd
1203 B, 12th Floor, Excel Center, No. 6,
Wudinghou Street, Xicheng District
Beijing, 100140
Tel: +86-10-8800 3755 Fax: +86-10-8800 3808
CZECH REPUBLIC Phadia s.r.o.
Ing. Milan Nemec
Drahobejlova 1019/27
19000 PRAHA 9
Tel: +420 220 518 743 Fax: +420 220 518 743
DENMARK Phadia ApS
Gydevang 33
DK-3450 ALLERD
Tel: +45-70 23 33 06 Fax: +45-70 23 33 07
FINLAND Phadia Oy
Rajatorpantie 41 c
FIN-01640 VANTAA
Tel: +358-9 8520 2560 Fax: +358-9 8520 2565
FRANCE Phadia S.A.S.
BP 610
FR-78056 ST QUENTIN-EN-YVELINES CEDEX
Tel: +33-1 61 37 34 30 Fax: +33-1 30 64 62 37
GERMANY Phadia GmbH
Postfach 1050 DE-790 10 FREIBURG
Tel: +49-761 47 805-0 Fax: +49-761 47805-338
GREAT BRITAIN Phadia Ltd
16 Shenley Pavilions, Chalkdell Drive
Shenley Wood, Milton Keynes, MK5 6LB
Tel: +44-1908 76 91 10 Fax: +44-844 324 94 95
INDIA Phadia India Pvt. Ltd
Unit No.07, 10 & 11, ground floor,
Splendor forum, plot no 03
Jasola, District Centre,
NEW DEHLI-110025
Tel: +91 11 461 075 55 / 56 Fax: +91 11 461 075 57
IRELAND Phadia Ltd. (Irish Branch)
27 Oakhill
Moate
Co. Westmeath
Tel: +44 1908 84 70 34 Fax: +44 1908 84 75 54
ITALY Phadia S.r.l.
Via Libero Temolo, 4
IT-201 26 MILANO
Tel: +39-0264 163 411 Fax: +39-0264 163 415
JAPAN Phadia K.K.
Tokyo Opera City Tower
3-20-2, Nishi-shinjuku,
Shinjuku-ku TOKYO JP-163-1431
Tel: +81-3 5365 83 32 Fax: +81-3 5365 83 36
KOREA Phadia Korea Co. LTD.,
20 Fl, IT Mirea Tower
60-21, Gasan-dong Geumcheon-gu
Seoul 153-801
Tel: +82-2-2027-5400 Fax: +82-2-2027-5404
THE NETHERLANDS Phadia B.V.
Postbus 696
NL-3430 AR NIEUWEGEIN
Tel: +31-30 602 37 00 Fax: +31-30 602 37 09
NORWAY Phadia AS
Postboks 4756, Nydalen
NO-0421 OSLO
Tel: +47-21 67 32 80 Fax: +47-21 67 32 81
PORTUGAL Phadia Sociedade Unipessoal Lda
Lagoas Park - Edifcio n11 - Piso 0
PT-2740-270 PORTO SALVO
Tel: +351-214 23 53 50 Fax: +351-214 21 60 36
SOUTH AFRICA Laboratory Specialities (PTY)
A Phadia Company
P.O. Box 1259
Ferndale 2160
Tel: +27 11 792 6790 Fax: +27 11 793 1064
SPAIN Phadia Spain SL
Ctra. Rub, 72-74 (Edifcio Horizon)
ES-08173 SANT CUGAT DEL VALLS (BARCELONA)
Tel: +34-935 765 800 Fax: +34-935 765 820
SWEDEN Phadia AB,
Marknadsbolag Sverige
P O Box 6460 SE-751 37 UPPSALA
Tel: +46-18 16 50 00 Fax: +46-18 16 63 24
SWITZERLAND Phadia AG
Sennweidstrasse 46
CH-6312 STEINHAUSEN
Tel: +41-43 343 40 50 Fax: +41-43 343 40 51
TAIWAN Phadia Taiwan Inc.
8F,-1, No. 147, Sec. 2, Jianguo N. Rd.
TAIPEI 104
Taiwan R.O.C.
Tel: +886-2 2516 0925 Fax: +886-2-2509 9756
USA Phadia US Inc.
4169 Commercial Avenue
Portage, Michigan 49002
Tel: +1 800-346-4364 (Toll Free) Fax: +1 269 492-7541
OTHER COUNTRIES Phadia AB,
Distributor Sales
P O Box 6460, SE-751 37 UPPSALA
Tel: +46 18 16 50 00 Fax: +46 18 16 63 65
Copyright and Trademarks
Patents
Phadia Systems may be covered by the following patents:
US Patent 4,647,655; 4,708,932; 5,822,069 and 5,895,630
European Patent 134 236 and 128 885
Japanese Patent 194 288 1 and 185 589 1
In addition pending patents.
Copyright
2012 Thermo Fisher Scientific Inc and its subsidiaries. All rights reserved.
Trademarks
The following designations are trademarks belonging to Thermo Fisher Scientific Inc and its
subsidiaries:
Celikey
EliA
ImmunoCAP
ImmunoCAP InVitroSight
Phadia
Phadiatop
Quality Club
Varelisa
Glossary
In this section you will find:
Terminology
Acronyms and Abbreviations
Terminology
A
Analyte The substance tested for. In the case of immunology, the antigen
or antibody being assayed.
Analytical Run AR A number of tests from the same method always calculated
against the same calibration curve. The maximum length of an
AR is defined by method parameters. An AR can never extend
through more than one Assay Run. The instrument will
automatically start a new AR for a method if the maximum
length is reached, or there is a change in conjugate lot (in the
latter case, a new curve will also be inserted first in the new
AR).
Assay The measurement of an analyte by a defined procedure.
Assay Run The time from which processing is started, up until end of
processing ordered by the operator. ("end of day"-command).
An assay run can contain a number of Analytical Runs, there
can also be more than one AR from the same method.
ASTM E1394-91 and A standard for communication between computer systems, for
ASTM E1381-95 example between the IDM and the LIS. ASTM E1394-91;
Standard Specification for Transferring Information Between
Clinical Instruments and Computer Systems ASTM E1381-95;
Standard Specification for Low-Level Protocol to Transfer
Messages Between Clinical Laboratory Instruments and
Computer Systems.
C
Calibration Curve Known concentrations of the analyte for curve fitting. The
measured response values for samples are evaluated against this
curve.
Calibrator A solution with known concentration of an analyte, used to
determine a reference response for that concentration.
Carrier Pen shaped tube, which carry several ImmunoCAP/EliA
Wells/Dilution Wells. The Carrier is marked with a barcode
describing its content.
CheckCAP A container used for certain instrument test functions.
Class A semi-quantitative test result.
Coefficient of Variation CV A measure of imprecision. See Quality Guide, Basic Concepts.
Concentration A quantitative test result, obtained by finding the point on a
calibration curve corresponding to the test response.
Conjugate An antibody or antigen labeled with a specific enzyme which
generates fluorescence.
Curve Control CC A solution with known concentration of an analyte, used to
verify that the stored Calibration Curve can be used.
Cut-Off A defined value from where a result is regarded as either positive
or negative.
%CV Limit A value defining the upper limit of the coefficient of variation
in a result with multiple determinations.
D
DataCAP format A communication protocol between IDM and LIS developed
by Phadia used mainly in Japan.
Development Solution Reagent, used as substrate in the enzymatic reaction.
Dilution Ratio A value specifying whether a sample is diluted or not. (E.g. "1"
means undiluted, "5" means 1 part sample and 4 parts of
diluent).
E
EliA Well Solid phase; a container coated with antigens and/or antibodies.
Eluate The reaction product that is measured by the fluorometer.
Export To transfer information from the instrument or IDM to a LIS
or another computer system.
F
FluoroC A fluorescent solution, for control and calibration of the
fluorometer.
Fluorometer The device measuring the fluorescence of the eluate.
I
ImmunoCAP Solid phase; a container containing a sponge bound with
antigens and/or antibodies.
IDM or Phadia Information The operator software for the Phadia system, that runs on the
Data Manager, system computer, a Microsoft Windows-based PC.
Import To transfer information from a LIS or another computer system
to the IDM or the instrument.
Instrument Dilution A dilution performed automatically in the Phadia 250 or Phadia
100 instruments, and in the EliA module of the Phadia 2500
and Phadia 5000 instruments.
L
Laboratory Automation An automated sample management system. A track system that
System (LAS) routes samples to the instrument for aspiration and from the
instrument when aspirated. The LAS reduces hands on time for
sample management. Available for Phadia 250 and Phadia 1000.
Laboratory Information Central computer on the laboratory to which an instrument
System (LIS) system can be connected. Also called a Mainframe.
Levey-Jennings Plot A graph of the values of a sequence of control samples, used
in assessing the quality of the assay process Curve Control (CC)
and Quality Control (QC).
Lot A quantity of reagent of a given type, or system, which is
manufactured at the same time and therefore can be assumed
to have the same characteristics.
M
Mainframe See Laboratory Information System (LIS).
MasterCAP format A communication protocol between IDM and LIS developed
by Phadia.
Method A set of parameters defining a method for performing assays,
defined by its set-up, procedure, measuring principle and data
evaluation.
Monthly Calibration Describes the use of stored calibration curves. A calibration
curve has to be run after a defined number of days or when a
new lot number of conjugate (and, if enabled in IDM, for some
methods also ImmunoCAP) is introduced, or if the Curve
Controls are out of range.
O
Operator The person who uses an instrument to perform testing and all
user actions necessary for this.
P
Phamas A communication protocol between IDM and LIS developed
by Phadia.
Phadia Information The operator software for the Phadia system, that runs on the
Data Manager or IDM system computer, a Microsoft Windows-based PC.
Predilution A dilution, performed outside the instrument.
Q
Quality Club An external quality assessment scheme, run by Phadia AB,
under which the quality of allergy, asthma and EliA
autoimmunity testing of the member laboratories is checked
periodically and the results published.
Quality Control (QC) A sample with known values, used to monitor the performance
of a method.
QC Pattern A schedule for which Quality Controls to be run and in which
order, selectable by the customer.
QC Rules A multi-rule QC procedure which uses a combination of decision
criteria, or control rules, to decide whether an analytical run is
in-control or out-of-control .
R
Raw Data The genuine, uncalculated, measured value from the
fluorometer, in terms of Response Units (RU).
Reaction product The final product of the enzyme reaction in the EliA assay
process that is measured by the fluorometer.
Reagent Any substance, normally a solution, which participates in a
chemical reaction.
Reagent Blank The fluorescence in a mixture of Development Solution and
Stop Solution, measured by the fluorometer. Development
Solution and Stop Solution are mixed in the same proportions
as in assay.
Replicate The number of assays of the same sample and test, used for
calculating a result.
Response The level of fluoroscence calculated from the fluorometer output
voltage, by taking into account blanking and multiplied by a
factor specific for the type of fluorometer.
Rinse Blank The fluorescence in Rinse Solution, measured by the
fluorometer.
Rinse Solution Purified water. Specification according to European
Pharmacopoeia 3 rd edition 2000 Supplement.
RU (Response Unit) Unit of fluoroscence level.
S
Sample Sample is the common name for patient samples and controls
(sometimes also curve controls and calibrators). Patient samples
are normally serum or plasma.
Shewhart Plot The same as Levey-Jennings plot.
Solid Phase A surface to which antigens or antibodies are bound, in this
case, ImmunoCAP or EliA Well
Specimen For instance a sample of serum, plasma etc.
Standard Deviation SD A measure of imprecision. See Quality Guide, Basic Concepts.
Stop Solution Reagent for terminating the enzymatic reaction.
Substrate See Development Solution.
System Computer See System Description .
System Reagents All reagents common for all analytes (Washing Solution, Rinse
Solution, Development Solution and Stop Solution).
T
Test The substance (specific analyte) coupled on ImmunoCAP or
EliA Well.
Test Result The value obtained after a measurement.
Unknown Sometimes used as a synonym for a patient sample.
VW
Washing Solution A solution containing Washing Solution Additive, Washing
Solution Concentrate and Purified water (Rinse Solution).
Acronyms and Abbreviations
AR Analytical Run
BAL Bronchoalveolar Lavage
CAL Calibrator point
CC Curve Control
CV Coefficient of Variation
ECP Eosinophil Cationic Protein
IgA, IgE, IgG, IgM (IgG4) Immunoglobulin A, E, G, M (IgG4 is a subgroup of the
Immunoglobulin G)
LAS Laboratory Automation System
LIMS Laboratory Information Management System
LIS Laboratory Information System
QC Quality Control
RU Response Unit
SD Standard Deviation
UPS Uninteruptable Power Supply
WHO World Health Organization
System Configuration
This section describes how to install the Phadia Information Data Manager (IDM) and the Phadia
250 User Manual. Information on how to configure the Phadia 250 System to meet your needs
is also included. You will also find information about updating the set of methods and articles
and also how to verify instrument performance.
Phadia IDM Setup
Installation and Upgrade

To install, or upgrade, the IDM software and the user manual, you need the Phadia Information
Data Manager Software Package installation CD-ROM. You can also download the installation
package from Phadia DiaNet.
The self-instructing setup program provides all information needed for the installation, making
the installation procedure simple. During the setup, the IDM program files and the user manual
are copied to the appropriate folders on your hard drive.
Useful Preferences and Settings

You can use the tabs of the Preferences window to change a number of software preferences
for the IDM. You can, for example, set parameters for automatic deletion of results and requests,
language, temperature and main screen icons. These are only a few of the large number of
parameters that can be set. For more information about the Preferences tab, see IDM Reference
Guide.
Note: To change any IDM preferences, you must first log in as a SuperUser.
Automatic Deletion of Results

You can configure the IDM to automatically delete the results for an analytical run after a certain
number of days:
1. In the IDM Workplace, click the PREFERENCES - F12 button. You can also press the F12
key on your keyboard.
2. In the Preferences window, select the Result tab.
3. Under the Result tab, select the Delete analytical run checkbox and enter the wanted number
of days in the Older than (days) field.
Automatic Deletion of Requests

You can configure the IDM to automatically delete requests after a certain number of days:
1. In the IDM Workplace, click the PREFERENCES - F12 button. You can also press the F12
key on your keyboard.
2. In the Preferences window, select the Result tab.
3. Under the Result tab, select the Delete requests checkbox, enter the wanted number of days
in the Older than (days) field and enter how often IDM should check in the Check every (days)
field.
Miscellaneous Settings
Under the Miscellaneous tab of the Preferences window you can, for example, change the
settings for language, temperature scale, barcode reader, and printer:
Selecting Working Language 1. In the IDM Workplace, click the PREFERENCES - F12
button. You can also press the F12 key on your keyboard.
2. In the Preferences window, select the Miscellaneous tab.
3. Under the Miscellaneous tab, select the wanted working
language from the Language drop-down list. When you close
the Preferences window, you will be prompted to confirm
the action.
Selecting Temperature Scale 1. In the IDM Workplace, click the PREFERENCES - F12
3. Under the Miscellaneous tab, select the Celsius or the
Fahrenheit option button in the Country Setting group box.
When you close the Preferences window, you will be
prompted to confirm the action.
Setting Barcode Reader 1. In the IDM Workplace, click the PREFERENCES - F12
Parameters button. You can also press the F12 key on your keyboard.
3. Under the Miscellaneous tab, click the SETTINGS button
in the Barcode Reader group box. The RS 232 Setting
window will open.
Setting Printer Parameters 1. In the IDM Workplace, click the PREFERENCES - F12
2. In the Preferences window, select the Printer tab.
3. Under the Printer tab, use the Print Options group box to
select how IDM should behave when printing:
Print on default printer (IDM prints directly)
Select printer (IDM shows the Select Printer window)
Preview (IDM shows the Print Preview window)
4. Under the Printer tab, select default printers for the different
report types in the Default Report Printers group box. When
you close the Preferences window, you will be prompted to
confirm the action.
Instrument Information
You can use the Main Screen tab to set certain instrument information parameters. You can, for
example, display and position icons for connected instruments in the IDM Workplace, or set
the number of days for messages in the instrument error log to be stored:
Renaming an Instrument 1. In the IDM Workplace, click the PREFERENCES - F12
2. In the Preferences window, select the Main Screen tab.
3. Under the Main Screen tab, select the wanted instrument
and click the OPEN button.
4. In the Instrument window, enter the new name for the
instrument and click the OK button.
Displaying/Hiding an 1. In the IDM Workplace, click the PREFERENCES - F12

Instrument Icon button. You can also press the F12 key on your keyboard.
4. In the Instrument window, select/deselect the Visible
checkbox and click the OK button.
Selecting a Shortcut Key 1. In the IDM Workplace, click the PREFERENCES - F12
for an Instrument button. You can also press the F12 key on your keyboard.
4. In the Instrument window, select a shortcut key from the
Shortcut Key drop-down list and click the OK button.
Positioning an 1. In the IDM Workplace, click the instrument name above

Instrument Icon the instrument icon and hold the left mouse button down
while moving the instrument icon to the wanted location.
2. Release the left mouse button.
or
1. In the IDM Workplace, click the PREFERENCES - F12

4. In the Instrument window, enter the X- and Y- positions
(in pixels) and click the OK button.
Setting Automatic Deletion 1. Start the SettingsTool program. It is located in the

of Instrument Error Messages TOOLS/SETTINGSTOOL subfolder in the IDM installation
folder.
2. Click the + sign to the left of the Instrument list item.
3. Select Error Remove in the list and enter the wanted number
of days in the text field. Then press the SET button.
4. Close the program.
Important System Parameters
You can use the tabs of the System window to set various system parameters for the IDM. You
can, for example, add, delete, edit or import methods, articles, or users.
Note: To make any system parameter changes, you must first log in as a Super User.
Method Management
When IDM is upgraded, Phadia methods in IDM will also be upgraded. The upgrade will normally
only affect Phadia controlled method parameters (i.e. non-editable parameters).
User methods will not be affected by an IDM upgrade.
Note: If you previously have installed a method diskette and IDM is upgraded, the methods in
IDM will also be upgraded. If the method diskette is newer than the methods in the IDM upgrade,
please re-install the method diskette.
Adding Methods 1. In the IDM Workplace, click the SYSTEM - F8 button, or

press the F8 key on your keyboard.
2. In the System window, select the Methods tab.
3. Under the Methods tab, click the NEW button.
Deleting Methods 1. In the IDM Workplace, click the SYSTEM - F8 button, or

3. Under the Methods tab, select the wanted method from the
methods list and then click the DELETE button. You can
delete user-defined methods only.
Editing Methods 1. In the IDM Workplace, click the SYSTEM - F8 button, or

3. Under the Methods tab, select the wanted method from the
methods list and then click the OPEN button. The
Method 'Method Name' window will open.
Importing Methods 1. In the IDM Workplace, click the SYSTEM - F8 button, or

3. Under the Methods tab, click the IMPORT button.
Exporting Methods 1. In the IDM Workplace, click the SYSTEM - F8 button, or

3. Under the Methods tab, click the EXPORT button.
Article Management
When IDM is upgraded, the articles in the IDM database will also be upgraded. Manually added
articles in IDM (or imported from an article file from a method diskette) may be affected, but
never deleted, by the IDM upgrade.
Unlike methods, it is normally not necessary to re-install articles from a method diskette after
an IDM upgrade (even if the article file from the method diskette is newer than the article file in
the IDM installation).
Adding Articles 1. In the IDM Workplace, click the SYSTEM - F8 button, or

2. In the System window, select the Articles tab.
3. Under the Articles tab, click the NEW button. The Article
window will open.
Deleting Articles 1. In the IDM Workplace, click the SYSTEM - F8 button, or

3. Under the Articles tab, select the wanted article from the
methods list and then click the DELETE button.
Editing Articles 1. In the IDM Workplace, click the SYSTEM - F8 button, or

3. Under the Articles tab, select the wanted article from the
methods list and then click the OPEN button. The Article
window will open.
Importing Articles 1. In the IDM Workplace, click the SYSTEM - F8 button, or

3. Under the Articles tab, click the IMPORT button.
User Information
Adding Users 1. In the IDM Workplace, click the SYSTEM - F8 button, or

2. In the System window, select the Users tab.
3. Under the Users tab, click the NEW button. The
New User/User window will open.
4. In the New User/User window, enter the necessary user
information and then click the OK button.
Deleting Users 1. In the IDM Workplace, click the SYSTEM - F8 button, or

3. Under the Users tab, select the wanted article from the
methods list and then click the DELETE button. You can
delete user-defined users only.
Editing User Information 1. In the IDM Workplace, click the SYSTEM - F8 button, or
3. Under the Users tab, select the wanted article from the
methods list and then click the OPEN button. The
New User/User window will open.
4. In the New User/User window, enter the new user
information and then click the OK button.
Phadia 250 Settings
Parameter Settings
Using the Parameter Setting screen, a wide rage of instrument parameters can be set. The settings
are grouped in 12 parameter groups.
There are two levels of access to the Parameter Setting screen:
Level 1: for SuperUsers
Regional
Barcode
Tube
Miscellaneous
Error/Warning
Basic Configuration
Module
Level 2: for Service Engineers
Blank
FluoroC
Fluorometer
Temperature
Special Protocol Setting
Opening the Parameter Setting Screen

To open the Parameter Setting screen, do the following:
1. Move to the Start screen on the instrument by pressing BACK till you get there.
2. On the Start screen, press UTILITIES.
3. On the Utilities screen, press PARAMETER SETTING. The Password screen will open.
4. Enter your password and press ENTER.
Changing a Parameter Setting

Depending on the parameter selected, the parameter value can be changed using option buttons,
a keyboard window, or a numerical keypad (TenKey) window.
1. On the Parameter Setting screen, press the wanted parameter group key (e.g. REGIONAL).
A parameter list will be displayed.
2. Use the blue arrow buttons to select a parameter (e.g. Date Format).
3. Press the Value field for the selected parameter. Depending on the parameter selected, the
Select Data screen, a keyboard window, or a numerical keypad window will open.
4. a. When the Select Data window is displayed, select the appropriate option button and then
press BACK.
b. When a keyboard window is displayed, use the keys to enter the new value and then press
CONFIRM. To return to the Parameter Setting window without changing the parameter,
press BACK.
c. When a numerical keypad window is displayed, use the keys to enter the new value and
then press CONFIRM. To return to the Parameter Setting window without changing the
parameter, press CANCEL.
5. Press REGISTER to save new parameter setting(s).
Regional Settings
You can set the following regional parameters:
Date Format
Date Separator
Time Format
Time Separator
Decimal Symbol
Temperature Unit
Language
Date Format
Options:
yyyy/mm/dd Year/Month/Day
dd/mm/yyyy Day/Month/Year
mm/dd/yyyy Month/Day/Year
Default setting:
yyyy/mm/dd Year/Month/Day
Date Separator
Options:
/ / (slash)
- - (minus)
Default Setting:
/ / (slash)
Time Format
Options:
hh:mm:ss Hour:Minute:Second (24h)
hh:mm am/pm Hour:Minute am/pm (12h)
hh:mm Hour:Minute (24h)
Default setting:
hh:mm:ss Hour:Minute:Second (24h)
Time Separator
Select between different Time Separator options.
Options:
: : (colon)
/ / (slash)
- - (minus)
Default setting:
: : (colon)
Decimal Symbol
Options:
. . (point)
, , (comma)
Default setting:
. . (point)
Temperature Unit
Options:
Celsius
Fahrenheit
Default Setting:
Celsius
Language
Options:
English
French
German
Italian
Japanese
Portuguese
Spanish
Swedish
Default Setting:
English
Barcode Settings
You can set the following barcode parameters:
Barcode Mode
Sample Barcode (Max: 4 Items)
Sample Barcode Start Position
Sample Barcode Length
Barcode Mode
This setting determines how the instrument will identify sample tubes.
Options:
Rack ID The instrument only reads barcode labels attached to the sample
racks. The location of the sample tubes in the rack is defined
in Phadia IDM.
Rack ID + Sample ID The instrument reads barcode labels on both the sample racks
and the sample tubes.
Default Setting:
Rack ID + Sample ID
Sample Barcode (Max: 4 Items)

Setting for active barcode types, used for sample tubes and sample racks. Interleave 2-5 (ITF) is
used for sample racks and MUST always be selected. You can only select 3 more barcode types
and Interleave 2-5 (ITF).
Options:
Code 39
Interleave 2-5 (ITF)
Industrial 2of5
Codabar (NW-7)
EAN-8
Code 128
COOP 2of5
Code 93
Default Setting:
Code 39
Interleave 2-5 (ITF)
Code 128
Code 93
Type the number for the position used as start reading position on the sample tube barcode labels.
Options:
1-16 Enter a value between 1 and 16
Default Setting:
1

Type the maximum number of characters allowed on the barcode labels.
Options:
1-16 Enter a value between 1 and 16
Default Setting:
16
Tube Settings
Settings for sample tube and QC bottle dimensions.
Note: Changes in Tube Settings should only be performed by a Phadia representative.
To change a value, first press the wanted dimension entry field. A numerical keypad window
will open. Use the keys to enter new values and then press BACK.
Note: The settings for the pipetting depth are only valid for ImmunoCAP. For EliA, the Pipetting
Depth settings are fixed and can not be changed. The Bottom Level settings will be used also for
EliA. If the volume for the EliA pipetting exceeds 40 l, the setting will be adapted automatically
to ensure a sufficient liquid volume.
Note: The settings for bottom level are not applicable for primary tubes. The surface of the gel
might not be horizontal. Make sure that there is sufficient sample volume above the gel for all
tests to be run including dead-volume, in order to avoid that the pipette aspirates gel.
A: Pipetting Depth. Pipetting Depth is the distance under
the surface the pipette must be (at least) to be able to aspirate
one replicate without getting air.
B: Bottom Level. Bottom Level is the position where the
pipette can detect the surface and still be able to aspirate one
last replicate.
Recommended settings:
Bottom Level. Must never be lower than Pipetting Depth.
Pipetting Depth. Must normally never be lower than 1.0 millimeter. The value shall be at least
the dept of 40 microlitres plus 0.6 millimeter safety margin. The minimum value is 0.9 mm.
Note: After changing these tube parameters check that pipetting work correctly.
Note: It is very important that correct tube settings are used. Please contact your local Phadia
representative if you need help defining Sample Tube and or QC bottle dimensions.
Testing and Entering Tube Settings
Tube settings must be done for Sample tube and Pediatric tube used. Settings for Quality Control
(QC) bottles are pre-defined.
Volume definitions:
A = Dead volume B = Aspiration volume
Bottom Level: The position where the pipette can detect

the surface and still be able to aspirate one last replicate.
Pipetting Depth: The distance under the surface the pipette
must be (at least) to be able to aspirate one replicate without
getting air.
It is very important to use the correct tube settings. Incorrect settings can result in process errors
and incorrect results. Change of tube settings MUST be performed by trained personnel only.
Description
Example: Check a dead volume of 100 l
Fill Sample Diluent in two Sample Tubes (the ones you want to enter Tube setting for):
Tube A : 100 l (dead volume that you want check)
Tube B : 140 l (dead volume that you want to check + 40 l, one aspiration volume).
Note: Recommendation is to use 100 l as dead volume because if you go lower the risk for
NOT aspirating correct volume is increasing rapidly. If you use a lower dead volume make sure
that the Check tube settings test can be repeated successfully.
Procedure
1. On the Start Menu screen, press UTILITIES.
2. Select Super User Maintenance and then Functional Test.
3. Select Sample Pipette Z-Position Check
4. Load Sample tube A in position 10 in a sample rack.
5. Load the sample rack into instrument position 1. Press CONFIRM in the Load Rack
Information window.
6. Set Sample Tube - Bottom Level to the value 0.0
7. Select tube to test Sample Tube or Pediatric Tube and press Start.
Note: Large QC and Small QC should not be altered.
8. An error message will appear when instrument detects the liquid in the tube.
Example of an error message for a normal Sample tube: Liquid level of sample 162 (0.01mm).
162 = 1.62 mm above the calibration point.
9. Press CLOSE on error messages when they appear, let the instrument detect liquid at least 5
times in tube A.
10. Press PAUSE
11. Remove tube A and insert tube B in position 10 in the Sample rack. Load Sample Rack in
instrument position 1. Press CONFIRM in the Load Rack Information window.
12. Press RUN and let the instrument detect liquid at least 5 times in tube B.
13. Press STOP, and then Press OK.
Calculating values to enter in Sample Tube settings

1. Press the INFORMATION key and then the ERROR LIST key.
2. Error messages will be at the top of the Error list. (Example with only three detections).
3. Calculate the mean value for tube A and tube B, Liquid level of sample.
Example: (using three instead of five liquid detections):

If the five values differ more than 0.10 perform a new set of five measures.
Tube A: 130, 132 and 132 = 1.31 mm
(mean 131 x 0.01 = 1.31 mm)
Tube B: 242, 242 and 244 = 2.42 mm
(mean 242 x 0.01 = 2.42 mm)
Enter Tube Settings

3. Select Tube Settings and enter values according to the description below for each respective
tube tested.
4. Bottom level: Insert the calculated mean value from tube B.
Example: Tube B mean value 2.42 mm. This value is the lowest point to find liquid to be
able to aspirate 40 l. In this example we have used 100 l as dead volume but it is possible
to use 50-200l depending on the tube shape.
Note: The settings must be checked after new values are introduced.
5. Pipetting depth: Insert the value calculated from this formula:
Value for tube B value for tube A + 0.60mm= X.XX mm
Example: 2.42 1.31 + 0.60 = 1.71 mm
Check the level drop in the table below, particularly for conical tubes.
For conical tubes use maximum 50% of the tube diameter
6. Press REGISTER to save values.
Theoretical Level drop of 40 l in mm at different tube diameters
Diameter Level drop Pipetting depth
4.0 3.18 3.78
5.0 2.04 2.64
6.0 1.41 2.01
7.0 1.04 1.64
8.0 0.80 1.40
9.0 0.63 1.23
10.0 0.51 1.11
12.0 0.35 0.95
14.0 0.26 0.86
Note: If several different normal sample tubes are used, the tube parameter settings must be
entered with the thinnest tube, with the thickest bottom. The default value inserted for the sample
tube can be used if the tubes do not have an inner diameter less than 9 mm. Recommendations
for tubes with a conical bottom is to use half the diameter of the tube to calculate level drop.
Check Tube Settings

1. Prepare three sample tubes C E (sample tubes that you entered settings for).
2. Tube C: Fill 1 tube with half of the dead volume used + 3 times the aspiration volume.
Example: 100 l dead volume (50 l + 3* 40 l).
3. Tube D: Fill 1 tube with the dead volume used + 3 times the aspiration volume.
Example: (100 l + 3*40 l)
4. Tube E: Fill 1 tube with 1.5 of the dead volume used + 3 times the aspiration volume.
Example: (150 l + 3*40 l)
Use a set of tubes C E for each different tube setting (normal, pediatric etc.).
Pipette Dispensing Test Procedure

3. Select Pipette Dispensing Test.
4. Select ImmunoCAP and then Sample and enter 10 in the Replicate field (marked in picture).
5. Press START.
Note: Do not change any other values.
This test is using the settings for normal tubes. If you want to test other tube settings (i.e.
pediatric, 3 and 4), enter the values for the tubes that you want to test in normal tube setting.
See Enter Tube Settings above.
To test pediatric tubes, insert the values from pediatric tubes 39.0 and 1.5 into normal tubes,
and then run the test.
Note: Do not forget to enter the correct values again in the correct positions in the Tube
parameter group of the Parameter Settings screen (normal tubes etc.).
6. Load prepared tube C in position 1 in a Sample rack and load the rack into rack position 1.
7. Press CONFIRM in the Load Rack Information window.
8. Continue with tube D and E following the same procedure
Messages that might occur during the procedure

Message 1-1528 during start.
If you get this error after pressing START, press NO. You do not want to change solution in the
wash buffer bottle.
Message 2-11
Select Pipetting Test.
Message 1-14
The instrument will prompt you to load 10 ImmunoCAP (CheckCAP). This is the number of
replicates you entered in the Pipette Dispensing Test window.
In the Immuno Reaction Wheel, the ImmunoCAP should be placed one position before Conjugate
wash 1 and onwards.
In the Enzyme Reaction Wheel, they should be placed in the ImmunoCAP/EliA Well eject
position and onwards
Note: When performing this test, you do not have to place any CheckCAP in the wheels. On
the other hand, you have to visually confirm the number of pipettings performed.
Press START.
Message 3-142
1. When you receive the error 3-142 for tube C, put tube D in position 1 and press RETRY.
2. When you receive the error 3-142 for tube D, put tube E in position 1 and press RETRY.
3. When test is completed, press BACK to return to menu without saving any changes.
Correct test results
Tube C The instrument was able to pipette ONE (1) or TWO (2) replicates.
Tube D The instrument was able to pipette TWO (2) or THREE (3) replicates.
Tube E The instrument was able to pipette THREE (3) or FOUR (4) replicates.
Dead volume in the tested tubes are the volume you used when performing the tube setting.
Action if results are not correct
1. First check that the APD calibration for sample tubes are correct.
2. If the instrument was able to pipette with more replicates, increase the pipetting depth value
and run Check tube settings again.
3. If the instrument was able to pipette with less replicates, decrease the pipetting depth value.
Register
Press REGISTER to save the new settings.
Back
Press BACK to return to the previous screen without changing any settings.
Miscellaneous Settings
Use the Miscellaneous Settings screen to change the following parameters:
After Assay: Washing/Rinse/Soak
After Assay: Automatic unload low frequent test
After Assay: Automatic unload empty carrier
After Assay: Automatic Power Off instrument
Eject Empty Carrier to Waste Box
Waste PipedOut
StartUp Time
SuperUser Password
Conjugate Tray List
Strip Tray List
Default Conjugate Tray
Default Strip Tray
Screen Saver Time
ImmunoCAP/EliA Well Store Section List
Report test as completed as soon as a fatale error has occurred for it
Cal/CC Measure: Automatic start
Color Pattern
Time Synchronization
Wash Volume Check when starting assay run

Set the options for Daily Rinse after assay.
Note: All checkboxes shall be marked in order to maintain good instrument performance.
After Assay: Automatic unloading of low frequent tests

Carriers which are defined as low frequent tests in Phadia Information Data Manager can be
automatically unloaded to the Loading Tray after assay.
Note: This function is not available in Scan Mode, when the Carriers on the Loading Tray are
registered. No Carrier can be transferred to or from the Storage Tray.
Options:
Yes automatic unload
No no unload
Default Setting:
No
After Assay: Automatic unloading of empty carriers

Empty ImmunoCAP / EliA Well carriers can be automatically unloaded after assay.
Options:
Yes automatic unload
No no unload
Default Setting:
No

Select if you want Phadia 250 to remain in Standby Mode, or be powered off after END ASSAY.
Options:
Yes automatic Power Off after assay
No standby mode after assay
Default Setting:
Yes

Select between different unloading procedures for empty carriers. Empty ImmunoCAP/ EliA
well carriers shall be unloaded to Carrier Loading Tray or disposed to the Waste Box.
Options:
Yes Empty carrier to Waste Box
No Empty carrier to Loading Tray
Default Setting:
No
Waste PipedOut
Choose if waste liquid shall be collected in the waste bottle or piped out via the drainage on the
right side of the instrument.
Options:
Yes Waste Liquid to drainage
No Waste Liquid to Waste Bottle
Default Setting:
No
StartUp Time
Select day and time for automatic power ON, in order to warm up the instrument and have it
ready in the morning. Time less than 30 minutes from actual time refers to start up time next
week.
Options:
Sunday Saturday
Yes automatic power on
No manual power on
hh:mm Hour:Minute
Default Setting:
No
08:00
SuperUser Password
Enter password and press CONFIRM
Option:
1-10 characters 0-9 and/or A-Z
No characters used Super User Password disabled
Conjugate Tray List

Use ; (semicolon) as a separator between the conjugate Tray ID (max 5 trays).
Default Setting:
C1;C2;C3;C4;C5
Strip Tray List

Use ; (semicolon) as a separator between the strip Tray ID (max 5 trays).
Default Setting:
S1;S2;S3;S4;S5

The tray to be used as default tray when loading a tray on the instrument.
No barcode reading needed.
Options:
C1 C5
Default setting:
C1
Default Strip Tray

The tray to be used as default tray when loading a tray on the instrument.
No barcode reading needed.
Options:
S1 S5
Default setting:
S1
Screen Saver Time

Enter time for screensaver in minutes.
Options:
0-4800
Default setting:
60

You can define certain ImmunoCAP Groups to the different carrier storage trays.
Each ImmunoCAP/EliA carrier has a group number. The Group number for all carriers is default
0 (zero). A carrier can only be loaded into a tray that has a corresponding number. Carrier group
numbers are set for each carrier in IDM.
Tray ID: ID-number of the ImmunoCAP / EliA well Carrier Storage Tray.
Use ; (semicolon) as a separator between the ImmunoCAP/EliA Well Group numbers (max 20
group numbers per Tray ID).
Default Setting:
Tray ID Group numbers
TA 0;1;2;3;4;5;6;7;8;9;10;11;12;13;14;15;16;17;18;19
TB 0;1;2;3;4;5;6;7;8;9;10;11;12;13;14;15;16;17;18;19
TC 0;1;2;3;4;5;6;7;8;9;10;11;12;13;14;15;16;17;18;19
TD 0;1;2;3;4;5;6;7;8;9;10;11;12;13;14;15;16;17;18;19
TE 0;1;2;3;4;5;6;7;8;9;10;11;12;13;14;15;16;17;18;19
TF 0;1;2;3;4;5;6;7;8;9;10;11;12;13;14;15;16;17;18;19
TG 0;1;2;3;4;5;6;7;8;9;10;11;12;13;14;15;16;17;18;19
TH 0;1;2;3;4;5;6;7;8;9;10;11;12;13;14;15;16;17;18;19
TI 20;21;22;23;24;25;26;27;28;29;30;31;32;33;34;35;36;37;38;39
TJ 20;21;22;23;24;25;26;27;28;29;30;31;32;33;34;35;36;37;38;39
Report test as completed as soon as a fatal error has occurred

for it
This option will make it possible to rerun a test immediately, if a fatal error has occurred.
YES: If a fatal error occurs for a test in process (e.g. no sample pipetting) the test is reported
back to IDM immediately.
NO: the test is reported when completed.
Options:
Yes Report immediately to IDM if error occurs
No Report when test completed
Default setting:
No
Cal/CC Measure: Automatic Start

Select if Calibrators and Curve Controls shall start processing when assay starts or when first
sample is loaded onto the instrument.
Options:
Yes Cal/CC start at assay start
No Cal/CC starts when first sample loaded
Default setting:
No
Color Pattern
To help color recognition, each color has a unique pattern (hatching pattern).
Options:
Off Color and No pattern, (see picture below)
On Color and Pattern, (see picture below)
Default setting:
Off
Option Off
Option On
The instrument will synchronize time with the IDM computer.
Enter User Name and Password to log on to the IDM computer.
Note: A user has to be created on the IDM computer to the corresponding setting.
Default setting:
User Name: IDM
Password: IDM
Wash Volume Check when starting assay run

Choose if the Wash Volume Check shall be performed at assay start.
Note: It is also possible to perform the check through Super User Maintenance.
Options:
Yes Perform Wash Volume Check
No Do not perform Wash Volume Check
Default Setting:
No
Errors/Warnings Settings
Use the Errors/Warnings screen to change the settings for all errors, warnings and messages.
Errors, warnings and messages are divided into 5 major groups.
Main
Sub System 1
Sub System 2
Sub System 3
Sub System 4
The following parameters can be changed for each error, warning or message:
Light unit (color signal of the attention light)
Beep (sound signal)
Screen Display (Not possible to edit)
Logging (Not possible to edit)
Light Unit options:
None No color indication (when Error/Warning/Message occur).
Yellow Yellow indication
Red Red indication
Beep options:
None No sound indication (when Error/Warning/Message occur).
PATTERN 1 Beep interval: _ _ _ _
PATTERN 2 Beep interval: ..
How to change a setting

1. Press the MAIN button, or the appropriate SUB SYSTEM button
2. The Error Setting List screen opens
3. Select Error No. (row)
4. Press MODIFY
5. The Error Modify screen opens
6. Make your selection
7. Press REGISTER
8. Press BACK
9. Press BACK again
Basic Configuration Settings
Use the Basic Configuration screen to change the following parameters:
UPS use
Accept low frequent test from IDM
UPS use
Select if a UPS (Uninterruptible Power Supply) is used or not.
(A UPS is a kind of external Power backup, which can be connected to the power inlet.)
Options:
No No UPS used
Use UPS connected to instrument
Default Setting:
No

Determine whether the instrument shall accept requests for Low Frequent test from IDM or not.
Each ImmunoCAP and EliA test can be defined as Normal used test or Low Frequent used test
in IDM. For more information, see Phadia User Manual.
Options:
No Do not accept
Yes Accept
Default setting:
Yes
Module Settings
Use the Module screen to change the following parameters:
Heater On/Off (Standby Mode)
Heater Off Timer
Determine whether the heater shall be used in standby mode or not.
Options:
Off Heater off during Standby
On Heater on during Standby
Default setting:
On
Heater Off Timer

The Heater Off Timer parameter defines the amount of time the heater is on after the assay is
finished (Standby mode is initiated).
Enter the time (in minutes) before the heater is powered off during standby.
Options:
1-999 (minutes)
Default setting:
100 (minutes)
Verification of Instrument Performance

To verify the instrument performance before using the instrument in routine runs, please follow
the instructions below.
Calculation of CV % Values
A number of laboratories have accreditation for running specified tests. To receive and obtain
this accreditation, proof regarding the quality of the results is requested. Below is a suggestion
on how to test the performance of different methods in Phadia instruments.
This protocol can also be used only to check the performance of a specific method or the
instrument. Examples are given below.
Other methods can use the same protocol as one of the examples below, for example to verify
Specific IgA the protocol for Specific IgG can be used, and to verify Tryptase the protocol for
ECP can be used.
Examples:
ImmunoCAP Specific IgE
ImmunoCAP Specific IgE 0-100
ImmunoCAP Total IgE
ImmunoCAP ECP and ImmunoCAP Tryptase
ImmunoCAP Specific IgG and ImmunoCAP specific IgA
ImmunoCAP Specific IgG4
EliA IgG, EliA IgA and EliA IgM
The following System Reagents are required:
Development Kit
Washing Solution
Note: Not all methods are available on all Phadia instruments.
Reagents for ImmunoCAP Specific IgE

ImmunoCAP Specific IgE Calibrators
ImmunoCAP Specific IgE Control L
ImmunoCAP Specific IgE Control M
ImmunoCAP Specific IgE Control H
ImmunoCAP Specific IgE Negative Control
Anti-IgE ImmunoCAP
ImmunoCAP Allergen d1
ImmunoCAP Allergen e1
ImmunoCAP Allergen t3
Protocol for acceptance of ImmunoCAP Specific IgE

Run 1:
Full calibration curve (0.35, 0.7, 3.5, 17.5, 50, 100 kU/l, in duplicates this is set as default in
the software when a calibration curve is requested).
ImmunoCAP Specific IgE Control L, M and H tested for three allergens (one for each control)
in duplicate.
ImmunoCAP Specific IgE Negative Control tested for the same three allergens as above, in
duplicate.
At least six individual patient samples in duplicate, any allergens.
Criteria for acceptance of Run 1:
IDM software accepts the curve.
The mean values for ImmunoCAP Specific IgE Control L, M and H are within given range.
ImmunoCAP Specific IgE Negative Control is negative for all replicates.
Run 2 and 3:
Curve controls 1 and 2 (single replicate, as default).
ImmunoCAP Specific IgE Control L, M and H tested for three allergens (one for each control)
in duplicate.
duplicate.
At least six individual patient samples (same as in the first run) in duplicate, same allergens
as in the first run.
Criteria for acceptance of Runs 2 and 3:
Curve controls are within range, the run is accepted by IDM software.
The mean values for ImmunoCAP Specific IgE Control L, M and H are within given ranges.
ImmunoCAP Specific IgE Negative Control is negative for all replicates.
Criteria for total acceptance of ImmunoCAP Specific IgE:
Criteria for Runs 1 through 3 are fulfilled.
Pooled coefficients of variation (CV) within runs are 6% for ImmunoCAP Specific IgE
Control L, M and H and patient samples.
Total CV (%) for ImmunoCAP Specific IgE Control and patient samples are 10%.
Printouts of laboratory reports and patient reports can be done. Calculate the CV as described in
Calculation Model.
If all the criteria for total acceptance are fulfilled, results can be used for clinical routine.
In order to maintain the instrument's performance, please follow instructions in Maintenance.
Reagents for ImmunoCAP Specific IgE 0-100

ImmunoCAP Specific IgE Calibrators 0-100
ImmunoCAP Specific IgE d1 Control
ImmunoCAP Specific IgE e1 Control
ImmunoCAP Specific IgE t3 Control
ImmunoCAP Specific IgE Negative Control
Anti-IgE ImmunoCAP
ImmunoCAP Allergen d1
ImmunoCAP Allergen e1
ImmunoCAP Allergen t3
or allergens included in other ImmunoCAP Specific IgE controls listed below;
ImmunoCAP Specific IgE g6 Control
ImmunoCAP Specific IgE m6 Control
ImmunoCAP Specific IgE w1 Control
ImmunoCAP Specific IgE f1 Control
Protocol for acceptance of ImmunoCAP Specific IgE 0-100
Run 1:
Full calibration curve (0, 0.35, 0.7, 3.5, 17.5, 100 kU/l, in duplicates this is set as default in
ImmunoCAP Specific IgE eg. d1 Control tested for three allergens (one for each control) in
duplicate.
duplicate.
At least six individual patient samples in duplicate, any allergens.
The mean values for ImmunoCAP Specific IgE Control L, M and H are within given range.
ImmunoCAP Specific IgE Negative Control will give results below 0.35 kUA/l with allergen
ImmunoCAP for all replicates.
Run 2 and 3:
ImmunoCAP Specific IgE eg. d1 Control tested for three allergens (one for each control) in
duplicate.
duplicate.
At least six individual patient samples (same as in the first run) in duplicate, same allergens
as in the first run.
Curve controls are within range, the run is accepted by the IDM software.
The mean values for ImmunoCAP Specific IgE Control L, M and H are within given ranges.
ImmunoCAP Specific IgE Negative Control will give results below 0.35 kUA/l with allergen
ImmunoCAP for all replicates.
Criteria for total acceptance of ImmunoCAP Specific IgE 0-100:
Pooled coefficients of variation (CV) within runs are <6% for ImmunoCAP Specific IgE
Control and patient samples.
Total CV (%) for ImmunoCAP Specific IgE Control L, M and H and patient samples are
<10%.
Calculation Model.
ImmunoCAP Total IgE
Reagents for ImmunoCAP Total IgE

ImmunoCAP Total IgE
ImmunoCAP Total IgE Calibrators
ImmunoCAP Total IgE Control L
ImmunoCAP Total IgE Control M
ImmunoCAP Total IgE Control H
Protocol for acceptance of ImmunoCAP Total IgE

Run 1:
Full calibration curve (2, 5, 50, 200, 1000, 5000 kU/l, in duplicates - this is set as default in
ImmunoCAP Total IgE Controls, three levels in duplicate.
At least six individual patient samples in duplicate.
The mean values for ImmunoCAP Total IgE Controls are within given ranges.
Run 2 and 3:
ImmunoCAP Total IgE Controls, three levels in duplicate.
Curve controls are within given ranges, the run is accepted by the IDM software.
The mean values for ImmunoCAP Total IgE Controls are within given ranges.
Criteria for total acceptance of ImmunoCAP Total IgE:
Pooled coefficients of variation (CV) within assay runs are 6% for ImmunoCAP Total IgE
Controls and patient samples.
Total CV (%) for ImmunoCAP Total IgE Control and patient samples are 10%.
Calculation Model.
In order to maintain the instrument in good shape, please follow instructions in Maintenance.
ImmunoCAP ECP and ImmunoCAP Tryptase
Reagents for ImmunoCAP ECP

ImmunoCAP ECP
ImmunoCAP ECP Calibrators
ImmunoCAP ECP Control
Protocol for acceptance of ImmunoCAP ECP and ImmunoCAP

Tryptase
Below you see an example for ImmunoCAP ECP. This is applicable also for Tryptase. The
reagents differ depending on the method selected.
Run 1:
Full calibration curve (2, 5, 15, 100, 200 g ECP/l, in duplicates - this is set as default in the
software when a calibration curve is requested).
ImmunoCAP ECP Control in four replicates.
The mean value for ImmunoCAP ECP Control is within given range.
Run 2 and 3:
Curve control 1 (two replicates, as default).
ImmunoCAP ECP Control in four replicates.
Curve control is within range, the run is accepted by IDM software.
The mean value for ImmunoCAP ECP Control is within given range.
Criteria for total acceptance of ImmunoCAP ECP:
Pooled coefficient of variation (CV) within assay runs are 6% for ImmunoCAP ECP Control
and patient samples.
Total CV (%) for ImmunoCAP ECP Control and patient samples are 10%.
Calculation Model.
If all the criteria for total acceptance are fulfilled results can be used for clinical routine.
In order to maintain the instrument in good shape, please follow instructions in Maintenance.
ImmunoCAP Specific IgG
Reagents for ImmunoCAP Specific IgG

IgG Calibrator ImmunoCAP
ImmunoCAP Specific IgG Calibrators
ImmunoCAP Specific IgG Curve Controls
ImmunoCAP Gi1
ImmunoCAP Specific IgG Control LMH
ImmunoCAP Specific IgG/IgG4 Control L
ImmunoCAP Specific IgG/IgG4 i1 Control H
Protocol for acceptance of ImmunoCAP Specific IgG

Run 1:
Full calibration curve (0.02, 0.04, 0.1, 0.3, 1.0, 2.0 mg/l, in duplicates - this is set as default
in the software when a calibration curve is requested).
All controls, tested in duplicate.
The mean values for the controls are within given ranges.
Run 2 and 3:
At least six individual patient samples (same as in the first run) in duplicate.
Curve controls are within range, the run is accepted by IDM software.
Criteria for total acceptance of ImmunoCAP Specific IgG:
Pooled coefficients of variation (CV) within runs are <8% for controls and patient samples.
Total CV (%) for controls and positive patient samples are <12%.
Calculation Model.
Reagents for ImmunoCAP Specific IgG4

IgA/IgG Calibrator ImmunoCAP
ImmunoCAP IgG4 Calibrators
ImmunoCAP Specific IgG4 Curve Controls
ImmunoCAP Gi1
ImmunoCAP Specific IgG Control LMH
ImmunoCAP Specific IgG/IgG4 Control L
ImmunoCAP Specific IgG/IgG4 i1 Control H
Protocol for acceptance of ImmunoCAP Specific IgG4

Run 1:
Full calibration curve (0, 3, 15, 35, 120, 300 g/l, in duplicates - this is set as default in the
Run 2 and 3:
At least six individual patient samples (same as in the first run) in duplicate.
Curve controls are within range, the run is accepted by the IDM software.
Criteria for total acceptance of ImmunoCAP Specific IgG4:
Pooled coefficients of variation (CV) within runs are <8% for controls and patient samples.
Total CV (%) for controls and positive patient samples are <12%.
Calculation Model.
EliA IgG, EliA IgA and EliA IgM
Reagents for EliA IgG

EliA IgG Conjugate
EliA Diluent
EliA ANA Control
EliA IgG Calibrators
EliA dsDNA Wells
In addition six individual patient samples per method are required.
Protocol for acceptance of EliA IgG, EliA IgA and EliA IgM
Below you see an example for EliA IgG. This is applicable also for EliA IgA and EliA IgM. The
reagents differ depending on method selected.
Run 1:
Full calibration curve (0, 4, 10, 20, 100, 600 g/l, in duplicates - this is set as default in the
EliA ANA Control, two levels in duplicate on EliA dsDNA Wells (define controls according
to Chapter 4, Assay Run Editing Functions).
At least six individual patient samples in duplicate on EliA dsDNA Wells.
The mean values for EliA ANA Control are within given range.
Run 2 and 3:
Curve control 1 (two replicates as default).
EliA ANA Control, two levels tested in duplicate on EliA dsDNA Wells.
At least six individual patient samples (same as in the first run) in duplicate on EliA dsDNA
Wells.
Curve control is within range, the run is accepted by IDM software.
The mean values for EliA ANA Control are within given ranges.
Criteria for total acceptance of EliA IgG:
Pooled coefficients of variation (CV) within runs are <8% for EliA ANA Positive Control
and positive patient samples.
Total CV (%) for EliA ANA Positive Control and positive patient samples are <12%.
Calculation Model.
Calculation Model
For two and four (ImmunoCAP ECP Control/ImmunoCAP Tryptase Control) replicates in each
of three runs the calculations are performed according to Table 1 and Table 2 respectively.
The obtained concentrations are entered into the cells within the double frame. The mean and
variance for each column (run) are calculated as follows:
where
xi = cell value
n = number of values
The mean and variance of the run means are calculated as above and entered as MTot and VMean.
The mean of the variances is also calculated and entered as VWithin. The coefficients of variation
are then obtained according to the formulas below the tables.
Table 3 and Table 4 are examples of typical results.
For your own calculations of CV (%), use the calculation form below.
Forms for Calculation

Calculation of CV (%) with two replicates in each of three runs.
Table 1
Replicate Run 1 Run 2 Run 3 MTot VMean

VWithin
1 - -
2 - -
Mean
Variance -
Calculation of CV (%) with four replicates in each of three runs.

Table 2

VWithin
1 - -
2 - -
3 - -
4 - -
Mean
Variance -
Examples of Calculation
Calculation of CV (%) with two replicates in each of three runs.
Table 3

VWithin
1 2.87 3.43 2.98 - -
2 3.01 3.27 3.20 - -
Mean 2.94 3.35 3.09 3.13 0.0430
Variance 0.0098 0.0128 0.0242 0.0156 -
Calculation of CV (%) with four replicates in each of three runs.

Table 4

VWithin
1 15.2 14.8 16.4 - -
2 15.9 15.1 16.5 - -
3 15.1 15.9 16.2 - -
4 15.8 15.4 17.3 - -
Mean 15.5 15.3 16.6 15.8 0.49
Variance 0.17 0.22 0.23 0.21 -

System Description
The fully automated, assay processing Phadia instruments are used for in vitro testing in clinical
areas such as allergy, asthma and autoimmunity. The operator loads reagents, samples and
ImmunoCAP/EliA Well Carriers into the instrument, while the rest of the operator interaction is
performed using Phadia Information Data Manager (IDM).
IDM is the operator software of the Phadia System.
This chapter describes the instrument(s) installed, IDM, the ImmunoCAP Technology and the
EliA Technology. Also the System Specification, Instrument Description and Instrument Software
are included.
ImmunoCAP and EliA Description

This chapter provides information about the ImmunoCAP and EliA technologies, as well as the
reagents that are needed to run an assay.
Note: All products are not available in all countries.
ImmunoCAP Technology
ImmunoCAP solid phase has the ability to extract the analyte molecules from the sample since
it has a three-dimensional structure covered with a large amount of either antigens/allergens
(binding specific antibody analytes) or specific antibodies (binding antigen analytes). These
antigens/allergens or antibodies are covalently coupled to the solid phase and reacts with the
molecule of interest in the patient sample.
The amplifier molecule has the function to specifically bind to the analyte molecule of interest
(using an antibody against the analyte) and to carry an enzyme able to perform an enzyme reaction.
In the ImmunoCAP system a non-fluorescent substrate is used. During the enzyme reaction, the
substrate is converted to a fluorescent product. The fluorescence is directly proportional to the
concentration of the analyte.
To evaluate the test results, the response for patient samples is compared directly to the response
for Calibrators.
ImmunoCAP Methods overview

The available ImmunoCAP methods are presented in the table below, along with the sample type
that is required to perform an assay.
Each method is described further in the sections below.
Method Sample
ImmunoCAP Specific IgE Human serum or plasma
ImmunoCAP Total IgE Human serum or plasma
ImmunoCAP Specific IgG Human serum or plasma
ImmunoCAP Specific IgG4 Human serum or plasma
ImmunoCAP Specific ECP Human serum
ImmunoCAP Specific Tryptase Human serum or plasma
Summary
ImmunoCAP Specific IgE measures the concentration of circulating allergen specific IgE
antibodies in human serum or plasma.
For further information, see ImmunoCAP Specific IgE, Directions for Use.
Test Principle
The allergen of interest, covalently coupled to the cellulose

carrier in ImmunoCAP, reacts with the specific IgE in the patient
sample.
After washing away non-specific IgE,

enzyme-labelled-antibodies against IgE are added to form a
complex.
After incubation, unbound-enzyme-anti-IgE is washed away

and the bound complex is then incubated with a developing
agent.
After stopping the reaction, the fluorescence of the eluate is

measured. The higher the fluorescence, the more specific IgE
is present in the sample. To evaluate test results, response for
patient samples is compared directly to response for calibrators.
Test Procedure
Sample Volume
The sample consumption for a single undiluted specific IgE test is 40 l. Note that the sample
volume needed depends on the type of sample tube used and the dead volume for that specific
tube.
Patient Sample Test
Patient samples are run in single determinations and evaluated against the stored calibration
curve. Results will automatically be stored in the system computer.
Quality Control
Good laboratory practice requires that quality control samples should be included in every
Analytical Run to check on assay performance. The quality control samples should be assayed
repeatedly to establish mean values and acceptable ranges.
For information about the available quality controls, see the product catalogue or contact your
local Phadia representative.
For more information about Quality Control, see chapter Quality Guide.
Practical Procedure
For information how to perform the test in practice, see chapter Operations.
Acceptance of Results
Calculation of Results
Calculation of results is performed automatically in the IDM.
Calibration Curve
In order to evaluate results for patient samples a calibration curve is needed. For this purpose,
the IgE concentration of specified calibrators is measured and the curve is automatically calculated
and stored.
The curve is valid until a new lot number of ImmunoCAP Specific IgE Conjugate is introduced,
or until Curve Controls (see below) are outside the specified limits, defined in the software, or
a time limit is reached.
For more information about Calibration, see Calibration and Acceptance in chapter Operations.
Curve Control
The stored calibration curve is checked by processing Curve Controls.
For more information about Curve Control, see Calibration and Acceptance in chapter Operations.
Measuring Range
Undiluted patient samples: 0 - 100 kUA/l or 0.35 - 100 kUA/l.
The measuring range can be extended by sample dilution with ImmunoCAP IgE/ECP/Tryptase
Sample Diluent.
ImmunoCAP Total IgE
Summary
ImmunoCAP Total IgE measures the concentration of circulating total IgE in human serum or
plasma.
For further information, see ImmunoCAP Total IgE, Directions for Use.
Test Principle
Anti-IgE, covalently coupled to the cellulose carrier in

ImmunoCAP, reacts with the total IgE in the patient serum
sample.
After washing, enzyme-labelled antibodies against IgE are added

to form a complex.
After incubation, unbound-enzyme-anti-IgE is washed away

agent.

measured. The fluorescence is directly proportional to the
concentration of IgE in the serum sample.
Test Procedure
Sample Volume
The samples consumption for a single undiluted Total IgE test is 40 l. Note that the sample
volume needed depends on the type of sample tube used and the dead volume of that specific
tube.
Patient Sample Test
Quality Control
Analytical Run to check on assay performance. Any material used should be assayed repeatedly
to establish mean values and acceptable ranges.
Practical Procedure
Calibration Curve
In order to evaluate results for patient samples, a calibration curve is needed. For this purpose,
the IgE concentration of specified calibrators is measured. The curve is automatically calculated
and stored.
This curve is valid until a new lot number of ImmunoCAP Total IgE Conjugate is introduced,
the time limit for use of the Calibration Curve is reached.
Curve Control
Measuring Range
Undiluted serum 2 - 5 000 kU/l.
The measuring range can be extended by sample dilution with ImmunoCAP IgE/ECP/Tryptase
Sample Diluent.
Summary
ImmunoCAP Specific IgG measures the concentration of specific IgG antibodies in human serum
or plasma.
For further information, see ImmunoCAP Specific IgG, Directions for Use.
Test Principle
The antigen of interest, covalently coupled to the cellulose

carrier in ImmunoCAP, reacts with the specific IgG in the
diluted patient serum specimen.
After washing away non-specific IgG,

enzyme-labelled-antibodies against IgG are added to form a
complex.
After incubation, unbound enzyme-anti-IgG is washed away,

agent.

measured. The higher the fluorescence, the more specific IgG
is present in the sample.
To evaluate test results, response for patient samples is
compared directly to response for calibrators.
Test Procedure
Sample Volume
The sample consumption required for a single, diluted, specific IgG test is 40 l. Note that the
sample volume needed depends on the type of sample tube used and the dead volume for that
specific tube.
Patient Sample Test
Quality Control
Practical Procedure
Calibration Curve
the IgG concentration of specified calibrators is measured (calibrators are run in duplicates) and
the curve is automatically calculated and stored.
The curve is valid until a new lot number of ImmunoCAP Specific IgG Conjugate is introduced,
Curve Control
Measuring Range
1:100 Diluted sample 2.0 - 200 mgA/l.
The range can be extended by further diluting with ImmunoCAP Specific IgA/IgG Sample
Diluent. When running Autoimmunity Specific IgG, use Autoimmunity Specific IgA/IgG Sample
Diluent.
Summary
ImmunoCAP Specific IgG4 measures the concentration of specific IgG4 antibodies in human
serum or plasma.
For further information, see ImmunoCAP Specific IgG4, Directions for Use.
Test Principle
The antigen of interest, covalently coupled to the cellulose

carrier in ImmunoCAP, reacts with the specific IgG4 in the
diluted patient serum specimen.
After washing away non-specific IgG4,

enzyme-labelled-antibodies against IgG4 are added to form a
complex.
After incubation, unbound enzyme-anti-IgG4 is washed away,

agent.

measured. The higher the fluorescence, the more specific IgG4
is present in the sample.
Test Procedure
Sample Volume
The sample consumption required for a single, diluted, specific IgG4 test is 40 l. Note that the
sample volume needed depends on the type of sample tube used and the dead volume for that
specific tube.
Patient Sample Test
Quality Control
Practical Procedure
Calibration Curve
the IgG4 concentration of specified calibrators is measured (calibrators are run in duplicates)
and the curve is automatically calculated and stored.
The curve is valid until a new lot number of ImmunoCAP Specific IgG4 Conjugate is introduced,
or until Curve Controls (see below) are outside the specified limits defined in the software, or
Curve Control
Measuring Range
1:100 Diluted sample 0 - 30 mgA/l.
The range can be extended by further diluting with ImmunoCAP Specific IgA/IgG Sample
Diluent.
ImmunoCAP ECP
Summary
ImmunoCAP ECP measures the concentration of Eosinophil Cationic Protein (ECP) in human
serum.
For further information, see ImmunoCAP ECP, Directions for Use.
Test Principle
Anti-ECP, covalently coupled to ImmunoCAP, reacts with the
ECP in the patient serum sample.
After washing, enzyme-labelled-antibodies against ECP are

added to form a complex.
After incubation, unbound-enzyme-anti-ECP is washed away,

agent.

concentration of ECP in the serum sample.
Sample Handling
Sample Volume
The sample consumption for a single, undiluted ECP test is 40 l. Note that the sample volume
needed is depending on the type of sample tube used and the dead volume for that specific tube.
Serum Sample Collection
See the instructions in the Directions for Use (DfU).
Note: Blood collection tube (Use Terumo Venosafe Serum-Gel tubes), coagulation time, and
temperature must be kept within specified limits, since these affect the concentration of released
ECP in serum samples.
Storage/Transport of Serum Samples
For shipping purposes, max 24 hours at room temperature.
Max 5 days in refrigerator (2 - 8 C).
-20C, or lower, if analyzed later.
Note: ImmunoCAP ECP has only been fully validated for serum samples.
Plasma and hemolyzed serum cannot be used.
For information on the assay in other media than human serum, please contact your local Phadia
representative.
Test Procedure
Patient Sample Test
Patient samples are run in single determinations, and evaluated against the stored calibration
Quality Control
Good laboratory practice requires that quality control samples should be included in every run
to check on assay performance. Any material used should be repeatedly assayed to establish
mean values and acceptable ranges.
Practical Procedure
Calibration Curve
the ECP concentration of specified calibrators is measured and the curve is automatically calculated
and stored.
The curve is valid until a new lot number of ImmunoCAP ECP conjugate is introduced, or until
Curve Controls (see below) are outside the specified limits, defined in IDM software, or the time
limit for use of the Calibration Curve is reached.
Curve Control
Measuring Range
Undiluted serum 2 - 200 g/l.
The range can be extended by sample dilution with ImmunoCAP IgE/ECP/Tryptase Sample
Diluent.
ImmunoCAP Tryptase
Summary
ImmunoCAP Tryptase measures the concentration of tryptase in human serum or plasma (heparin,
EDTA).
For further information, see ImmunoCAP Tryptase, Directions for Use.
Test Principle
Anti-tryptase, covalently coupled to ImmunoCAP, reacts with

the tryptase in the patient serum sample.
After washing, enzyme-labelled-antibodies against tryptase are

added to form a complex.
After incubation, unbound-enzyme-anti-tryptase is washed

away, and the bound complex is then incubated with a
developing agent.

concentration of tryptase in the serum sample.
Sample Handling
Sample Volume
The sample consumption for a single, undiluted tryptase test is 40 l. Note that the sample volume
needed is depending on the type of sample tube used and dead volume for that specific tube.
Sample Collection
Samples should preferably be taken between 15 minutes and 3 hours after the suspected event
causing mast cell activation.
Venous blood should be collected, allowed to stand half an hour to reach room temperature, and
then the serum or plasma should be separated by centrifugation.
The increased levels of tryptase can normally be detected up to three to six hours after the
anaphylactic reaction. Levels return to normal within 12 - 14 hours after release. The in vivo
half-life for tryptase is around two hours.
There is no interference in ImmunoCAP Tryptase of bilirubin, haemoglobin, and lipaemia. The

assay is not significantly affected by heterophilic antibodies.
Dilution and Preparation
No dilution of samples is usually required. However, for determination of values higher than 200
g/l samples can be diluted with ImmunoCAP IgE/ECP/Tryptase Sample Diluent (available from
Phadia AB upon request).
Storage/Transport of Serum Samples
Serum samples may be stored:
For shipping purposes, max 2 days at room temperature.
Max 5 days in refrigerator (2 to 8 C).
At -20 C or lower, if analyzed later.
Avoid repeated freezing and thawing.
Other Kinds of Samples
EDTA-plasma and Heparinised plasma can be used.

For information on the assay of tryptase in other human body fluids, please contact your local
Phadia representative.
Test Procedure
Patient Sample Test
Quality Control
Good laboratory practice requires that quality control samples should be included in every run
to check on assay performance. The quality control samples should be assayed repeatedly to
establish mean values and acceptable ranges.
Practical Procedure
Calibration Curve
In order to evaluate results for patient samples a calibration curve is needed. For this purpose the
tryptase concentration of specified calibrators is measured, and the curve is automatically
calculated and stored.
The calibration curve is valid for one month, or until a new lot number of ImmunoCAP Tryptase
Conjugate is introduced, or until curve control (see below) is outside the specified limits, defined
in the software, or the time limit for use of the Calibration Curve is reached.
Curve Control
The stored calibration curve is checked by processing only one Tryptase Curve Control, run in
duplicate. The instrument will automatically notify the user if the curve control is outside of the
specified limits
For more information about curve control, see Calibration and Acceptance in chapter Operations.
Measuring Range
Undiluted sample 1 - 200 g/l.
The range can be extended by sample dilution with ImmunoCAP IgE/ECP/Tryptase Sample
Diluent.
EliA Technology
EliA technology solid phase has the ability to extract analyte molecules from the sample, since
it has its surface covered with antigens binding to specific-antibody analytes. The components
binding to the EliA Well surface are hydrophobically adsorbed to the polystyrene. The surface
is, thereafter covered by a protection layer of proteins and sugar, which is mainly used to stabilize
the binding components during storage and to reduce background effects during the assay.
The amplifier molecule has the function to specifically bind to the analyte molecule of interest
(using an antibody against the analyte) and to carry an enzyme able to perform an enzyme reaction.
In the EliA system a non-fluorescent substrate is used. During the enzyme reaction, the substrate
is converted to a fluorescent product. The fluorescence is directly proportional to the concentration
of the analyte.
To evaluate the test results, the response for patient samples is compared directly to the response
for Calibrators.
EliA Methods Overview

The available EliA methods are presented in the table below, along with the sample type that is
required to perform an assay.
Each method is described further in the sections below.
Method Sample
EliA IgG Human serum or plasma
EliA IgA Human serum or plasma
EliA IgM Human serum or plasma
EliA Calprotectin Human stool
EliA IgG
Summary
EliA IgG measures the concentration of antigen-specific IgG antibodies in human serum or
plasma.
For further information, see the analyte specific Directions for Use and the corresponding EliA
Control DfU.
Test Principle
The antigen of interest, coated to the polystyrene surface of the

EliA well, reacts with the specific IgG in the diluted patient
serum specimen.
After washing away non-specific IgG,

enzyme-labelled-antibodies against IgG are added to form a
complex.
After incubation, unbound enzyme-anti-IgG is washed away,

agent.
After stopping the reaction, the fluorescence of the reaction

product is measured. The higher the fluorescence, the more
specific IgG is present in the sample.
Test Procedure
Sample Volume
All tests/analytes of the EliA IgG method have to be diluted. Each analyte has a default dilution
factor. The sample consumption required for a single, prediluted, EliA IgG test is 90 l. If the
Phadia 250 instrument dilution is used the required consumption depends on the dilution factor:
1:10 (one-step dilution) = 9 l raw sample
1:50 or 1:100 (two-step dilution) = 20 l raw sample
Note: The sample volume needed depends on the type of sample tube used and the dead volume
for that specific tube.
Patient Sample Test
Patient samples are run in single determinations (default setting) and evaluated against the stored
calibration curve. Results will automatically be stored in the system computer.
Quality Control
repeatedly to establish mean values and acceptance ranges.
Practical Procedure
For information how to perform the test, see chapter Operations.
Calculation of results is performed automatically by IDM.
Calibration Curve
the IgG concentration of specified calibrators is measured in Phadia 250 (calibrators are run in
duplicates) and the curve is automatically calculated and stored.
Note: All EliA IgG calibrator wells that will run in one calibration curve have to have the same
lot specific code.
The curve is valid for one month or until a new lot number of EliA IgG Conjugate is introduced,
or until Curve Controls (see below) are outside the specified limits, defined in the software.
Curve Control
Note: As long as the calibration curve is valid the EliA IgG calibrator wells used for measurement
of curve controls have to have the same lot specific code as the calibration wells of the stored
calibration curve.
Calibration Range
The calibration curve range is 0 - 600 g/l.
The determined IgG g/l concentration will automatically be converted into an analyte specific
unit. The measuring range is analyte and lot specific. The range can be extended by further
diluting with EliA Sample Diluent.
EliA IgA
Summary
EliA IgA measures the concentration of antigen-specific IgA antibodies in human serum or
plasma.
For further information see the analyte specific Directions for Use and the corresponding EliA
Control DfU.
Test Principle

EliA well, reacts with the specific IgA in the diluted patient
serum specimen.
After washing away non-specific IgA,

enzyme-labelled-antibodies against IgA are added to form a
complex.
After incubation, unbound enzyme-anti-IgA is washed away,

agent.

specific IgA is present in the sample.
Test Procedure
Sample Volume
All tests/analytes of the EliA IgA method have to be diluted. Each analyte has a default dilution
factor. The sample consumption required for a single, prediluted, EliA IgA test is 90 l. If the
Patient Sample Test
Quality Control
Practical Procedure
Calculation of results is performed automatically by the IDM.
Calibration Curve
the IgA concentration of specified calibrators is measured in Phadia 250 (calibrators are run in
Note: All EliA IgA calibrator wells that will run in one calibration curve have to have the same
lot specific code.
The curve is valid for one month or until a new lot number of EliA IgA Conjugate is introduced,
Curve Control
Note: As long as the calibration curve is valid the EliA IgA calibrator wells used for measurement
calibration curve.
Calibration Range
The determined IgA g/l concentration will automatically be converted into an analyte specific
EliA IgM
Summary
EliA IgM measures the concentration of antigen-specific IgM antibodies in human serum or
plasma.
Control DfU.
Test Principle

EliA well, reacts with the specific IgM in the diluted patient
serum specimen.
Note: The IgM Antibody is a pentamer not a monomer;
however this picture shows schematically the test principle.
After washing away non-specific IgM,

enzyme-labelled-antibodies against IgM are added to form a
complex.
After incubation, unbound enzyme-anti-IgM is washed away,

agent.

specific IgM is present in the sample.
Test Procedure
Sample Volume
All tests/analytes of the EliA IgM method have to be diluted. Each analyte has a default dilution
factor. The sample consumption required for a single, prediluted, EliA IgM test is 90 l. If the
Patient Sample Test
Quality Control
Practical Procedure
Calibration Curve
the IgM concentration of specified calibrators is measured in Phadia 250 (calibrators are run in
Note: All EliA IgM calibrator wells that will run in one calibration curve have to have the same
lot specific code.
The curve is valid for one month or until a new lot number of EliA IgM Conjugate is introduced,
Curve Control
Note: As long as the calibration curve is valid the EliA IgM calibrator wells used for measurement
calibration curve.
Calibration Range
The determined IgM g/l concentration will automatically be converted into an analyte specific
EliA Calprotectin
Summary
EliA Calprotectin measures the concentration of calprotectin in stool.
Control DfU.
Test Principle
Phase Description
Monoclonal antibodies directed against calprotectin are coated

to the polystyrene surface of the EliA well. If present in the
patients stool, calprotectin binds to the coated antibodies.
After washing away non-bound components, enzyme-labeled

antibodies against human calprotectin (EliA Caprotectin
Conjugate) are added to form a calprotectin-conjugate complex.
After incubation, unbound conjugate is washed away, and the

bound complex is then incubated with a developing agent.

mixture is measured. The higher the response value, the more
calprotectin is present in the sample.
To evaluate test results, the response for patient samples is
compared directly to the response for calibrators.
Test Procedure
Sample volume
In order to measure Calprotectin, approximately 100 mg of stool is needed for extraction. The
extraction is performed according to the corresponding EliA Control DfU. The EliA Calprotectin
test requires a 1:100 dilution of the stool extraction.
Patient Sample Test
Quality Control
Practical Procedure
Calibration Curve
the calprotectin concentration of specified calibrators is measured in Phadia 250 (calibrators are
run in duplicates) and the curve is automatically calculated and stored.
Note: All EliA Calprotectin calibrator wells that will run in one calibration curve have to have
the same lot specific code.
The curve is valid for one month or until a new lot number of EliA Calprotectin Conjugate is
introduced, or until Curve Controls (see below) are outside the specified limits, defined in the
software.
Curve Control
Note: As long as the calibration curve is valid the EliA Calprotectin calibrator wells used for
measurement of curve controls have to have the same lot specific code as the calibration wells
of the stored calibration curve.
Measuring Range
Measuring range of the calibration curve is 0 - 750 g/l.
The determined calprotectin g/l concentration will automatically be converted into mg/kg. The
measuring range is analyte and lot specific. The range can be extended by further diluting with
EliA Sample Diluent.
ImmunoCAP/EliA Reagents
This section describes the different analytes that currently can be processed in Phadia instruments.
You will also find a section about general reagent handling.
Analytes
The following analytes can be processed in Phadia instruments:
ImmunoCAP Total IgE
ImmunoCAP IgG4
ImmunoCAP Specific IgA
ImmunoCAP ECP
ImmunoCAP Tryptase
EliA IgG
EliA IgA
EliA IgM
EliA Calprotectin
Each ImmunoCAP / EliA analyte requires the following:
System Reagents
Note: Not all analytes can be processed on all instrument types.
Reagents
System and method specific reagents

The reagents used in the Phadia system can be divided into method specific reagents and system
reagents.
Method specific reagents are:
Conjugate
Calibrators
Curve Controls
ImmunoCAP/EliA Well
Quality Control
Diluent
System reagents are:
Development Solution
Stop Solution
Washing Solution
The reagents are specified in the Directions for Use provided with the reagent kit.
Method Specific Reagents

All method specific reagents (Conjugate, Calibrators, Curve Controls, ImmunoCAP/EliA Well,
Quality Control, and Diluent) required are presented in the Product Catalogue, 52-5100-01.
Note: Not all method specific reagents can be used with all instrument types.
System Reagents
All system reagents (Development Solution, Stop Solution and Washing Solution) required are
presented in the Product Catalogue, 52-5100-01.
The specification is purified water is according to European Pharmacopoeia 3 rd edition 2000
Supplement, see the description in the Trouble Shooting chapter of this manual.
Rinse Solution is not provided by Phadia.
Description:
Rinse Solution
Art. no. Not provided by Phadia
Application For rinsing of Elution Well and Fluorometer

Cuvette between tests.
For rinsing the complete system when closing
down.
Specification Purified Water

Mobile Label
For Rinse Solution. About use, see Routine
Operation, Load/Unload instrument in chapter
Operations.
Volumes Prepared Rinse Solution: 2 x 5 l
Preparation Purified water
Storage Prepared Rinse Solution in instrument:

1 week
Instrument Reagents
All instrument reagents (ImmunoCAP Maintenance Solution, Service Controls and FluoroC)
required are presented in the Product Catalogue, 52-5100-01.
Accessories
All accessories required are presented in the Product Catalogue, 52-5100-01 in association with
each instrument.
Reagent Handling
To make sure that achieved results are correct and to minimize errors and for error handling
during assay, the following subjects are most important to consider.
Evaporation
Good laboratory practice dictates that every precaution must be taken to avoid evaporation and
contamination to guarantee reliable results. Try to minimize the time period between uncapping
the reagents and loading them into the instrument.
Note: The quality control samples of the ImmunoCAP methods have to be recapped and removed
from the instrument as soon as the pipetting of the samples are finished and the serum incubation
is started. The EliA quality control samples are single use. They have to be discarded after the
run. The quality control samples should be stored at 2 - 8 C.
Contamination
It is important to make sure that the correct cap is screwed to the corresponding vial or bottle.
Do not touch the threads of the cap or the vial. Development Solution is sensitive to contamination
by conjugate. IgG conjugate are sensitive to contamination by patient samples.
Pooling
Note: It is not recommended to pool any reagents.
Air bubbles and fibrin clots

It is important to pop air bubbles on the surface of reagents and samples. Use a disposable pipette
tip to avoid contamination. If you notice fibrin clots on the sample, remove them with a disposable
pipette tip to avoid contamination.
Mix-up
Use Load Reagents display on the instrument to verify that the Calibrator/Curve Control Strips
are loaded in the correct position in the Pipette/Strip tray.
Securing reagent volumes

Use the Load List to verify that necessary volume of reagents is available. Always fill the system
with Washing solution and Rinse solution and empty Waste bottles before starting an assay.
Never use reagents for more determinations than recommended.
Preparation of Reagents
Washing solution
Follow instructions in Directions for use or the User Manual.
Make sure the Washing solution is well mixed before using it.
How to prepare Washing Solution is thoroughly described in chapter Operation/Reagent
Management/Load reagents/Preparation of Washing Solution. This is very important.
Calibrator and Curve Control strips
All Calibrator and Curve Control strips should be gently mixed before assay start. Also strips
stored on-board should be gently mixed before use. This is of great importance.
Before loading a Calibrator/Curve Control strip:
Carefully shake the strip side by side.
Force all liquid to the bottom of the strip by gently knocking it onto a table.
Make sure no foam or air bubbles are in the strip after shaking it.
Note: The recommendation is to mix all strips before use.
Phadia 250 System
System Computer Specifications

Electric Safety and Compatibility
The system computer is CE marked. That means that, among others, the following directives are
fulfilled:
the EMC-directive (2004/108/EEC)
the low voltage directive (73/23/EEC)
Environmental Requirements
Environmental requirements for the system computer are the same as for the ImmunoCAP
instruments.
Note: For more information about the computer specification, see the IDM Reference Guide.
Phadia Information Data Manager (IDM)

Phadia Information Data Manager (IDM) is the operator software designed for the Phadia
instruments: Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000. The operator
software runs on the system computer, a Microsoft Windows-based PC. You can connect up to
5 instruments of each instrument type to the system PC using serial cables and the TCP/IP
protocol.
IDM provides features for certain tasks included in the in vitro allergy and autoimmunity testing
procedure. Using IDM you can import request data from, or export request data to, a connected
mainframe (LIS) computer, create requests and Assay Runs, and retrieve test results from the
instrument(s). There are also features for managing patients, requestors, result data, printouts,
and Quality ClubTM, as well as a login/logout function and facilities for changing the IDM settings
and parameters.
Note: Depending on your IDM configuration, some windows and features described in this
manual may not be present.
IDM on Multiple Workstations
IDM can be set up on several computers using the same database for monitoring purposes. These
'Office IDM' workstations are primarily used to view results or monitor instrument operation and
assay data, and many IDM features will be disabled. For more information about IDM on multiple
workstations, consult you local Phadia representative.
IDM Shortcuts
When working with the IDM, you can use various shortcuts to access certain features faster.
Alt + E
In IDM Workplace, you can use this shortcut to exit IDM or shut down the computer. This
shortcut has the same function as the Exit IDM icon.
Alt + F12
You can use this shortcut anywhere in the IDM to open the Barcode window for manual entry
of a barcode.
To enter a barcode, type the code in the entry field and then click the OK button.
Note: If you enter the barcode for a sample included in a request, the Request window will open
displaying the request. If you enter the barcode for an article, the Barcode Decode window will
open.
To close the Barcode window without entering a barcode, click the CANCEL button.
Alt + H
You can display, hide, or move list columns using the Column Settings window. To open this
window, make the wanted list active by clicking in it and then press ALT + H.
Alt + 'Tab Number'

In all windows containing tabs, you can easily jump from one tab to another by pressing ALT +
'TAB NUMBER', i.e. the number of the tab from left to right.
Barcode Decode Window
Use the Barcode Decode window to view information about the article representing the barcode
entered in the Barcode window. You can also add article items to, or remove article items from,
the laboratory stock.
Window Items
The Barcode Decode window provides the following features:
Barcode Information Group Box
Barcode Field Displays the barcode for the article.
Lot number Field Displays the lot number for the article.
Expire Date Field Displays the expiry date for the article.
QC Limits Fields When applicable, Displays the QC limits for the article.
Target Value Field When applicable, displays the target value for FluoroC articles
Lot Specific Code Field When applicable, displays the lot specific code for the article.
Quality Club Period Field When applicable, displays the period of time for the Quality
Club sample.
Quality Club Tests Field When applicable, displays the tests to be processed with the
Quality Club sample.
Article Information Group Box
Full name Field Displays the full name for the article.
Barcode Field Displays the barcode for the article.
Type Field Displays the article type.
Identity Field When applicable, displays the identity of the article.
Method Field When applicable, displays the method to which the article
belongs.
Quantity Field Displays the number of units per package of the article.
Intended market Field Displays the market for which the article is intended to be used.
Amount to add Field Enter the number of article items to add to the laboratory stock.
Add To Stock Click this button to add the article item(s) to stock.
Button
Phadia 250 Max hours in instrument. When applicable, displays the max.
number of hours the bottle/strip/ ImmunoCAP carrier can stay
Information
in the Phadia 250 instrument after it is loaded into the tray
(accumulated time).
Max days after load. When applicable, displays the max.
number of days the bottle can stay in the Phadia 250 instrument
tray.
ImmunoCAP 1000 Max days after load. When applicable, displays the maximum
number of days the article can be stored in the ImmunoCAP
Information
1000 instrument after load.
Amount to dispose Field Enter the number of article items to remove from the laboratory
stock.
Remove From Stock Click this button to remove the article item(s) from stock.
Button
Close Button
Click this button to close the Barcode Decode window.
IDM Printouts
From within the IDM, a large number of documents can be printed. This section describes how
to perform these printouts, and also provides links to the appropriate sections in the System
Description part of this manual.
When you click a print button within the IDM, the printout procedure will be carried out according
to the print option selected under the Printer tab of the Preferences feature:
The document will be printed on the default printer
You will be able to select a printer for the printout
A preview window will open (default setting)
Note: From anywhere in the IDM, you can print the current screen by pressing ALT+P.
Phadia 250 Instrument
Inventory List To print an Phadia 250 inventory list:

1. In the IDM Workplace, click the icon for the wanted Phadia
250 instrument.
2. In the Phadia 250 'Instrument Name' window, select the
Inventory tab and click the PRINT button.
Loadlist To print an Phadia 250 loadlist:

250 instrument.
Loadlist tab and click the PRINT button.
Consumption Statistics To print Phadia 250 consumption statistics:

250 instrument.
Consumption tab and click the PRINT button.
Note: Consumptions statistics will only be possible to print if
there is data available for the selected period.
Messages List To print an Phadia 250 messages list:

250 instrument.
Messages tab and click the PRINT button.
Blanks/FluoroC Log To print an Phadia 250 blanks or FluoroC log:

250 instrument.
Log tab and click the PRINT button.
Log Book
To print logged IDM and instrument messages:
1. In the IDM Workplace, double-click the Log Book icon.
2. In the Log Book window, click the PRINT button.
IDM Help Printout
To print the manual section covering the current IDM window:
1. From anywhere in the IDM, click the HELP - F1 button (bottom left on your screen), or press
the F1 key on your keyboard.
2. In the Help window, click the PRINT button.
Sample Report
To print a sample report for one or more samples in the database:
1. In the IDM Workplace, click the REQUEST - F2 button, or press the F2 key on your keyboard.
2. In the Request List window, select the wanted sample(s) under the Samples tab and then
click the PRINT button.
3. In the Print list or reports window, select the Print sample reports option and then click the
OK button.
4. The Print Sample Report window will open.
Sample List
To print a sample list for one or more samples in the database:
click the PRINT button.
3. In the Print list or reports window, select the Print sample list option and then click the OK
button.
4. The Print Sample List window will open.
Consumables List
To print a list of consumables needed to process the selected samples:
click the CONSUMABLES button.
Note: If this button is not visible, click the MENU button.
3. In the Consumables window, select the wanted instrument and then click the PRINT button.
Outsourced Tests List

To print a list of outsourced tests:
2. In the Request List window, select the Samples tab.
3. Activate the Samples tab menu by clicking the MENU button. The Samples Tab With Menu
Activated window will open.
4. Click the OUTSOURCED TESTS button.
5. The Outsourced Tests window will open.
6. Select the outsourced tests you want to print a list of and then click the PRINT button.
Note: If no tests are selected, the complete list will be printed.
Patient Report
To print a patient report for one or more patients in the database:
2. In the Request window, select the wanted patient(s) under the Patients tab and then click the
PRINT button.
3. In the Print list or reports window, select the Print patient reports option and then click the
OK button.
4. The Print Patient Report window will open.
Patient List
To print a patient list for one or more patients in the database:
2. In the Request window, select the wanted patient(s) under the Patients tab and then click the
PRINT button.
3. In the Print list or reports window, select the Print patient list option and then click the OK
button.
4. The Print Patient List window will open.
Sample List For Requestor

To print a sample list for a requestor in the database:
2. In the Request window, select the wanted requestor under the Requestors tab and then click
the PRINT button.
3. The Print Sample list for requestor 'Requestor ID' will open.
Laboratory Report
To print a laboratory report for an Analytical Run:
1. In the IDM Workplace, click the RESULT - F3 button, or press the F3 key on your keyboard.
2. In the Result window, select the wanted Analytical Run and then click the PRINT button.
3. In the Laboratory report print options window, make wanted selections and then click the
OK button.
Quality Printouts
To print calibrator information, a curve control log, a quality control log, or a Quality Club result
card:
1. In the IDM Workplace, click the QUALITY - F4 button, or press the F4 key on your keyboard.
2. In the Quality window, select the wanted instrument, method and tab.
3. To print calibrator information:
Select the Calibrators tab and the wanted calibrator from the calibrators list.
Click the PRINT button.
4. To print a curve control log:
Select the Curve Controls tab and the wanted curve control from the curve controls list.
5. To print a quality control log:
Select the Quality Controls tab and the wanted quality control from the quality controls
list.
6. To print a Quality Club result card:
Select the Quality Club tab and the wanted QC sample from the samples list.
Method Information
To print method information:
1. In the IDM Workplace, click the SYSTEM - F8 button, or press the F8 key on your keyboard.
2. In the System window, select the Methods tab and then click the PRINT button.
3. In the Print method options window, make wanted selections and then click the OK button.
Note: If no method is selected, all methods will be printed.
Method Statistics
To print method statistics:
2. In the System window, select the Methods tab and then click the STATISTICS button.
3. In the Method Statistics window, select wanted period and then click the PRINT button.
Article Register
To print information about all articles currently defined:
2. In the System window, select the Articles tab and then click the PRINT button.
Note: When printing all articles, the print preview (if activated) may not be displayed (too
many pages).
User Report
To print information about all users currently defined:
2. In the System window, select the Users tab and then click the PRINT button.
Requestors
To print information about all requestors currently defined:
2. In the System window, select the Request Info tab and then click the PRINT button.
3. In the Print Requestors options window, make wanted selection (Address list, Full list or
simple list) and then click the OK button.
Stock List
To print a list of all articles in stock:
1. In the IDM Workplace, click the STOCK - F7 button, or press the F7 key on your keyboard.
2. In the Stock Manager window, click the PRINT button.
3. In the Print options window, select the Print stock option and then click the OK button.
List For Stocktaking

To print a list of articles where the actual number of items in stock is corrected as a result of
stocktaking:
2. In the Stock Manager window, click the PRINT button.
3. In the Print options window, select the Print list for Stocktaking option and then click the
OK button.
Order
To print an order for articles:
2. In the Stock Manager window, click the ORDER button.
3. In the Orders window, select the wanted order and click the PRINT button.
Sample Rack Information

To print information about one or more selected sample racks:
1. In the IDM Workplace, click the RACK - F5 button, or press the F5 key on your keyboard.
2. In the Rack List window, select the wanted sample rack(s) and click the PRINT button.
Phadia 250 Specification
General Instrument Specification
Performance
Features Automated dispensing, processing, and measuring.
Capacity The instrument is capable of running 6 different methods in a

single shift
Test result rate: 200 - 250 tests/day.
Continuous process.
Maximum number of samples at the same time: 50 (5 racks
with 10 sample tubes in each). Continuous sample load.
Maximum number of stored ImmunoCAP/EliA well Carriers:
180 ImmunoCAP/EliA well Carriers in storage, split in 3
Storage Trays. Phadia 250 can keep track of 10 trays.
38 urgency/STAT positions in Carrier Loading Tray.
Reagent Capacity:
Conjugate Compartment: 6 vials.
Development Compartment: 2 vials
Stop Solution: 2 bottles
Process Times From standby to operation: 25 min

From entering the first sample until it is processed: 100 min for
ImmunoCAP and about 120 min for EliA
Temperatures Environmental (operational) temperature: 18 to 32 C

Carrier Storage temperature: 2 to 8 C
The Processing Chamber 37 C.
Environmental Requirements Temperature: 18 to 32 C

(ambient) Air humidity: 10 - 85 %RH
Air pressure: 750 to 1060 millibar
Allowed temperature change: 2 C / hour (max)
Non-operational temperature: 5 to 32 C (Loaded with reagents,
system liquids, and ImmunoCAP / EliA well)
Limitation of Monthly Temperature and humidity during the calibration period should
not vary more than 7 C and 35 %RH.
Calibration Period
Example: 22-29 C and 35-70 %RH.
Sound Level 65 dBA at 1 meter
Heat Contribution 550 W (average) or 1901 Btu/h

Physical Specifications
Instrument Dimensions Width: 1 270 mm

(unpacked) Depth: 750 mm
Height (including attention light): 1140 mm
Height (including table): 1820-1860 mm
Instrument Table Width: 1 270 mm

Depth: 750 mm
Height: Adjustable 680 to 720 mm
Instrument Dimensions Width: 1 500 mm

(packed) Depth: 1 000 mm
Height: 2 000 mm
Weight Instrument: 340 kg (empty), 350 kg (loaded)

Packaged: 460 kg
Transportation and Storage Requirements
Transportation Temperature: -20 to +60C
Storage Requirements Temperature: -20 to +60C

Allowed thermal shock: 1C / 10 min
Air humidity: < 95% RH (+25 - +55C), non-condensing
Electrical Specifications
Mains Power Supply 100 V (+10%, -10%), 50/60 Hz

120 V (+10%, -10%), 50/60 Hz
220 V (+10%, -10%), 50/60 Hz
230 V (+10%, -10%), 50/60 Hz
240 V (+10%, -10%), 50/60 Hz
Not user adjustable.
Note: Phadia 250 instrument must be installed by a Phadia
service engineer and in accordance with the installation guide
and local regulations.
Power Consumption Power: 1.2 kVA.
Primary Fuses 220 - 240 V: 10 A

100 -120 V: 25 A
Not user resettable
Signal Interface Interface ports for external alarm, Ethernet connection and
barcode reader are available.
These ports must be connected only to external equipment
meeting the appropriate EMC and electrical safety standards.
The barcode and Ethernet ports must only be connected to
products supplied by Phadia AB.
Fluorometer Specifications
Fluorometer Excitation filter: Schott UG-1

Emission filter:
Center wavelength: 447 3 nm
Full width half max: 30 5 nm
Transmission: 65% min
Lamp:
UV-LED
Tubes, Sample, and Reagent Specifications
Note: The density limits should be considered an approximation. The density limit depends on
the print quality of the barcode as well as type of barcode used.
Tube Dimensions Diameter: 10 to 17 mm

Height: 50 to 110 mm
Sample Barcodes Length: <= 70 mm

Density: >= 10 mil
Pipette Volumes
Sample ImmunoCAP Volume: 40 l

EliA Volume: 90 l
Conjugate ImmunoCAP Volume: 50 l

EliA Volume: 90 l
Dead volume: 200 l
Development Solution ImmunoCAP Volume: 50 l

EliA Volume: 90 l
Dead volume: 0.5 ml
Stop Solution Volume: 200 l

Dead volume: 2 ml
Wash Solution ImmunoCAP Volume: 150 l

EliA Volume: 210 l 250 l
Liquid Volumes
Development Solution 2 vials (185 ImmunoCAP determinations/vial)

(170 EliA determinations/vial)
Stop Solution 2 bottles (194 ImmunoCAP determinations/bottle)

(560 EliA determinations/bottle)
Wash Solution 1 bottle x 10 l
Rinse Solution (purified water) 1 bottle x 10 l
Waste Bottle 1 bottles x 20 l
Phadia 250 Instrument Description
Overview
Process overview
The Phadia 250 instrument is a fully automated analyzer to be used with ImmunoCAP and EliA
reagents. It takes care of all the steps from Sample Pipetting to Measurement. The Sample Request
information is downloaded from IDM, and the measured values are sent back for calculation and
evaluation. All the processing is done inside ImmunoCAP/EliA Well.
The processing steps performed are:
ImmunoCAP EliA Well
ImmunoCAP Dispensing EliA Well Dispensing
Pre Wash -
Sample Pipetting Sample Pipetting
Sample Incubation Sample Incubation
Sample Wash Sample Wash
Conjugate Pipetting Conjugate Pipetting
Conjugate Incubation Conjugate Incubation
Conjugate Wash Conjugate Wash
Development Solution Pipetting Development Solution Pipetting
Development Incubation Development Incubation
Elution with Stop Solution Pipetting of Stop Solution
- Transfer of reaction product
Measurement Measurement
The Processing Flow also contains a number of rinse steps and movements of the
ImmunoCAP/EliA well.
Top View
The instrument features loading areas for samples, diluents, conjugates, ImmunoCAP/EliA Well
Carriers, Development and Stop Solution on the instrument. The processing takes place in the
processing chambers underneath a plastic cover behind the loading areas.
The different loading areas from left to right:
Stop Solution
FluoroC
ImmunoCAP/EliA Well Carrier
Conjugate
Dilution Plate
Diluent
Sample
Calibrator/CC
The operators panel is accessible from the front.
Two Moving Arms, one to the left, and one to the right, take care of sample and reagent pipetting,
loading of ImmunoCAP/EliA well Carrier and ImmunoCAP/EliA well.
Front View
From the front you load Sample Racks and a Carrier Loading Tray. The operators panel and a
diskette drive or a USB port are provided beside a Manual Barcode Reader.
The Wash Solution Bottle and Rinse Solution Bottle, the Fluid Waste Container and the Solid
Waste Container are located on the shelf underneath the instrument.
Operators Panel
Touch Screen
The Operators Panel consists of a Touch Screen. Just press the key or entry field you want to
activate.
You will find the different Instrument Screens described in Instrument SW.
Every screen has a row of keys in the lower part:
Action Keys
The three keys to the left are all for selecting a new display.
Toggle Key
If this key is blue, more than three actions are possible in the display. You can then toggle the
action keys with this key.
Common Keys
Back
BACK takes you back to previous menu.
Information
Information provides Error List, Temperature Monitor, and some Parameter Settings.
Message
Only active if a message exists.
Keyboard Screen
In normal procedures you only use the Touch Screen, but it is also possible to enter information
using the keyboard as well. By pressing the entry field the screen change to a keyboard, which
works by pressing the different characters you want to enter.
Special Keys
Small letter - Capital letter
You can toggle between small and capital letters (default) on the keyboard.
Space
The Space button is between the + and > buttons.
BS
Back Space. Use this key to delete the character to the left of the cursor.
Cursor Arrows
Moves the cursor to the right or left.
Confirm
Press CONFIRM to save the entered data.
Back
Press BACK to close the Keyboard Screen without saving the entered data.
Password Screen
The Password Screen is used for entering password where it is required.
Diskette Drive or USB port

The Diskette Drive is located under the Touch Screen, and is used to copy result files on to a
3.5" diskette.
Instruments with serial number greater than 600 have a USB-port instead of a diskette drive. To
save data use a portable flash memory in the USB-port. Use the USB-port only for this purpose.
Manual Barcode Reader

A manual barcode reader is located in the middle of the front. This is for reading the barcode on:
Development Solution Vial
Stop Solution Bottle
Washing Solution Outer Label
Calibrator Strip
Curve Control Strip
FluoroC Vial
Conjugate Vial
Diluent Vial
Conjugate Tray
Strip Tray
Carrier Storage Tray
ImmunoCAP/EliA Well Carrier (not full carriers)
You activate the barcode reader by pushing the reader inwards. It is activated up to 20 seconds
after a reading.
To read the barcode you move the vial, bottle or tray pass the reader.
Processing Flow
1. ImmunoCAP/EliA Well Dispensing

ImmunoCAP/EliA well Carrier is collected from ImmunoCAP Storage and an
ImmunoCAP/EliA well is dispensed into the Immuno Reaction wheel (incubation chamber).
2. Pre Wash
Wash Volume >400 l Washing Solution (not for EliA wells)
3. Sample Pipetting
No dilution/Pre-diluted samples
A. Sample Pipette moves to Sample Tube and aspirates sample
B. Moves to its corresponding ImmunoCAP/EliA Well and dispenses 40 l of sample into
ImmunoCAP or 90 l into EliA well, respectively.
C. Moves to Sample Pipette Rinse position for rinsing with Washing Solution
Instrument dilution (not included in figure)
Dilution up to 1:10 will be performed in a one-step dilution inside the pipette. Dilution with
higher dilution factors will be performed in two steps. First step is a 1:10 dilution in the
Dilution plate; second corresponding dilution will be done inside the pipette.
One-step dilution:
Volume depends on technology and dilution factor.
Example EliA wells 1:10 dilution: 81 l of diluent + 9 l sample
Two-step dilution:
First step: 180 l of diluent + 20 l sample
Second step: Example EliA wells 1:100 dilution: 81 l of diluent + 9 l out of the Dilution
plate
4. Sample Incubation
Incubation for 30 min in a temperature controlled area, 37 C
5. Sample Wash
Wash Volume >1000 l Washing Solution per ImmunoCAP and >800 l Washing Solution
per EliA well
6. Conjugate Pipetting
A. Pipette moves to Conjugate Bottle in Conjugate Compartment and aspirates conjugate
B. Moves to ImmunoCAP/EliA well and dispenses 50 l of conjugate into ImmunoCAP
or 90 l into EliA well, respectively
C. Moves to rinse position for rinsing with Washing Solution
7. Conjugate Incubation
Incubation for 24 min for ImmunoCAP and 28 min for EliA well in a temperature controlled
area, 37 C
8. Conjugate Wash 1
Wash Volume >1100 l Washing Solution per ImmunoCAP and >800 l Washing Solution
per EliA well
9. Conjugate Wash 2
Wash Volume >1100 l Washing Solution per ImmunoCAP (not done for EliA)
10. Conjugate Wash 3
Wash Volume >800 l Washing Solution per ImmunoCAP (not done for EliA)
11. Move to Development Carousel
The ImmunoCAP/EliA well is transported from the IRW (Immuno Reaction Chamber) to the
ERW (Development Carousel)
12. Development Pipetting
A. Pipette moves to Development Solution Bottle and aspirates
B. Moves to ImmunoCAP/EliA well in Enzyme Reaction Chamber and dispenses 50 l of
Development Solution into ImmunoCAP or 90 l into EliA wells, respectively
C. Moves to rinse position for rinsing
13. Development Incubation
Incubation for 9 min for ImmunoCAP and 39 min for EliA well in a temperature controlled
area, 37 C.
14. ImmunoCAP: Elution 1
A. Pipette moves to Stop Solution Bottle and aspirates 600 l
B. Stop Solution portion 1, 200 l per ImmunoCAP (not done for EliA)
EliA: Stop solution pipetting
A. Pipette moves to Stop Solution Bottle and aspirates 200 l.
B. Pipette moves to corresponding elution well and dispenses 200 l of Stop solution
C. Stop Solution portion 2, 200 l per ImmunoCAP (not done for EliA)
D. Stop Solution portion 3, 200 l per ImmunoCAP
E. Moves to rinse position for rinsing (not done for EliA)
EliA: Transfer of processed Development solution
D. Pipette moves to EliA well and after two time mixing aspiration of 80 l of processed
Development solution
C. Pipette moves to corresponding Elution well and dispense 80 l of processed
Development solution
E. Pipette moves to rinse position for rinsing (not done for ImmunoCAP)
17. Measurement
Aspirates eluate into the fluorometer.
18. Rinse Fluorometer
19. Disposal of ImmunoCAP/EliA well
Aspiration of surplus liquid in the ImmunoCAP/EliA well
20. Elution Well Rinse
Strip Tray
The following strips are loaded in the Strip Tray:
Calibrator Strips
Curve Control Strips
The tray contains 8 positions for Calibrator Strips and Curve Control Strips.
Calibrators
Calibrators are provided in a strip with 6 positions, one for each calibrator point. The strip is
covered by a sealing foil. The calibrators are pipetted with the Sample Pipette.
The Sample Pipette first makes two small holes in the foil in the first well. The pipette is then
rinsed. After rinsing pipetting take place from the first well.
The procedure is then repeated for each well.
Curve Controls
Curve Controls are provided in a strip with 6 positions. The strip is enough for three determinations
for all methods exept ECP, where the strip is enough for six determinations.
The strip is covered by a sealing foil. The Curve Controls are pipetted with the Sample Pipette.
The pipetting procedure is the same as for Calibrators
Barcode Reading
Barcodes on strips, vials, bottles and trays are read by the Manual barcode Reader .
Moving Arms
The Moving Arms are covered by a protection hood during operation.
Left Moving Arm

The Left Moving Arm has three main functions:
1. ImmunoCAP/EliA well Carrier Transport
2. Pipetting of Development and Stop Solution
3. ImmunoCAP/EliA well Transfer
Right Moving Arm

The right moving arm is for pipetting of Sample, QC, Conjugate, Calibrators/CC, and Diluent.
ImmunoCAP/EliA Well Distribution

This part describes:
Carrier Loading Tray
ImmunoCAP Transport Unit
Carrier storage
ImmunoCAP/EliA Well Transfer
Waste Handling
ImmunoCAP/EliA well Carriers are loaded manually in the Carrier Loading Tray.
ImmunoCAP/EliA well Carriers are transported from the Carrier Loading Tray to Carrier Storage
by the ImmunoCAP Transport Unit.
The same unit is used for transport of the ImmunoCAP/EliA well Carrier to the Incubation
Compartment, where ImmunoCAP/EliA wells are dispensed into correct position in the carousel.
Each Carrier Loading Tray contains 38 positions split in 5 rows. The tray is placed in the
ImmunoCAP Loading area to the left at the front.
Two LED's to the right indicates:
Yellow Locked - Do not try to remove the tray
Green Unlocked - It is OK to remove the tray
Loading of ImmunoCAP/EliA well starts in the rearmost left position.

Phadia 250 can keep track of 10 Carrier Loading Tray.
ImmunoCAP Transport Unit

ImmunoCAP Transport Unit is located on the Left Moving Arm .
This takes care of the transport of ImmunoCAP/EliA well Carriers from the Carrier Loading
Tray to the Carrier Storage and from the Carrier Loading Tray or the Carrier Storage for dispensing
of ImmunoCAP/EliA wells into the Processing Chamber. Empty ImmunoCAP/EliA well Carriers
are put back into an empty loading tray or into the Solid Waste Container.
Single ImmunoCAP/EliA wells are transferred from the Immuno reaction wheel to the Enzyme
reaction wheel.
Carrier Storage
Carrier Storage is located under a circular cover in the front of the instrument and is refrigerated.
Carrier Storage is divided into three sectors, called Carrier Storage Tray. Each tray can store 60
ImmunoCAP/EliA well Carriers. Phadia 250 can keep track of 10 trays.
ImmunoCAP/EliA Well Dispenser

ImmunoCAP/EliA Well Dispenser is a mechanical device for taking the ImmunoCAP/EliA well
out of the carrier and load it into the IRW (Immuno Reaction Chamber). It is located just above
the carousel.
ImmunoCAP/EliA Well Transfer

The transfer of ImmunoCAP/EliA wells between the Immuno Reaction Wheel and the Enzyme
Reaction Wheel is done by means of the ImmunoCAP Transport Unit .
The arm moves to a defined position to pick up a transfer tool, moves to the last position in the
Immuno Reaction Wheel, goes down and grabs the ImmunoCAP/EliA Well, moves to the first
position in the Enzyme Reaction Wheel and releases it.
Sample Loading
Sample Rack
Quality Control Rack
Sample Loading Area
Sample Rack
The Sample Rack contains 10 positions for sample tubes. You can use any major tube with an
outer diameter of 10 to 17 mm, and a height of 50 to 110 mm.
barcodes are located on the Sample Rack and read by the same reader used for the Sample Tubes.
Quality Control Rack

The Sample Rack is also used for Quality Controls. The number of the Quality Control Racks
must be predefined.
Sample Loading Area

5 Sample Racks can be loaded into the Sample Loading Area, located to the right.
Two LED's underneath each rack indicates:
Yellow Locked, in process - do not try to remove rack
Green Unlocked - it is possible to remove the rack
One barcode reader for the Sample Tubes and the Sample Racks is located at the right of the
Sample Loading Area. The design makes it possible to read the barcode for every tube position
in the loading area.
Sample Pipetting
The sample pipetting is handled by a pipette located on the Right Moving Arm. A capacitive
level sensor in the pipette senses when the pipette hits the sample surface.
Reagent Loading
Reagents are loaded into different places in the instrument.
Conjugate is loaded into the Conjugate Compartment, which is refrigerated and located just on
the top of the Touch Screen.
Diluent is loaded into the Diluent Storage, located at the front of the instrument, just above the
Touch Screen.
Development Solution is loaded into the Development Solution Compartment to the left on top
of the instrument.
Stop Solution is loaded to the left on the top of the instrument.
Calibrators and Curve Controls are loaded into the Strip Tray.
Quality Controls are loaded in a Sample Rack that is defined as a QC Rack.
Wash- and Rinse Solutions are located outside the instrument. They are connected at the rear of
the instrument.
Conjugate Compartment
The Conjugate Vials are loaded in 6 different positions in a Conjugate Tray, that are loaded in
the Conjugate Compartment. The compartment is refrigerated and it is covered by a protection
shield, with apertures for the pipetting positions. A sensor controls that the cover is in position.
The volumes in the vials are measured by the level sensor on the conjugate pipette after loading.
The barcode is to be read by the Manual Barcode Reader before loading.
Conjugate Pipetting
The Conjugate is pipetted into the Incubation Carousel by means of the pipette on the right
moving arm. A capacitive level sensor detects the surface of the liquid.
The pipette is rinsed after each pipetting, both inside and outside.
Dilution
Diluent Storage
The Diluent Storage contains 6 positions for Diluent vials.
Diluent Pipetting
A capacitive level sensor detects the surface of the liquid.
Dilution Principle
Dilution 1:10 (one-step dilution):
The Pipette aspirates diluent, moves to the sample tube and aspirates sample. Then moves to the
sample dispensing position at the processing chamber, and dispenses all. The pipette moves to
the wash station and is washed inside and outside.
Dilution 1:50 and 1:100 (two-step dilution):
In the first step the pipette on the right moving arm aspirates diluent, moves to the sample tube,
aspirates sample, moves to the dilution well of the microtiterplate (=dilution plate), dispenses all
liquid and mixes the liquid in the dilution well. The pipette moves to the wash station and is
washed inside and outside.
In the second step, a dilution, as described in Dilution 1:10 above is performed using the prediluted
sample from the dilution plate.
Dilution Plate
It is mandatory to use a round-bottom microtiterplate with 96 cavities (Art. No 12-3907-08) as
dilution plate. Please contact your Phadia representative for more information.
System Reagents
System Reagents are reagents that are not analyte-specific:
Stop Solution
FluoroC
Washing Solution
Rinse Solution
Development Solution/Stop Solution Compartment
There are two positions for Development Solution vials. The principle is that two vials are loaded,
one full, and one for pipetting.
Note: The ongoing vial must be in position 1.
A level sensor on the pipette controls the volume in the vials.
The Barcode on the vial is read by means of the Manual Barcode Reader .
Development Solution Pipetting

The Development Solution is pipetted to the Development Carousel by means of the Reagent
Pipette on the Left Moving Arm . A level sensor detects the surface of the liquid.
The pipette is rinsed after every pipetting, both inside and outside.
Stop Solution Bottles

Two Bottles of Stop Solution are loaded at the left side of the instrument. The principle is that
two vials are loaded, one full, and one for pipetting.
Stop Solution is pipetted with the pipette on the Left Moving Arm .
The barcode is read by the Manual Barcode Reader before loading.
FluoroC
FluoroC is for calibratiing of the fluorometer and is loaded into the front position in the
Development/Stop Solution Compartment , and is pipetted with the pipette on the Left Moving
Arm .
Washing Solution Bottles

One bottle with Washing Solution is placed on the shelf underneath the instrument. A full bottle
contains 10 l and dead volume is below 500 ml.
The barcode on the outer label is to be read by the manual barcode reader before loading. The
bottle is filled with Washing Solution before start. It can be refilled during processing without
disconnecting the tubing.
The Washing Solution is pumped into the Wash Buffer Bottle, located behind the Processing
Chamber, and from there to the different Wash Stations, described in Wash . Wash solution used
by the Right Arm pipette is pumped to a Shoulder buffer cup located at the rear of the Right Arm.
Rinse Solution Bottles

One bottle with Rinse Solution is placed on the shelf underneath the instrument. A full bottle
contains 10 l and dead volume is below 500 ml.
The barcode on the outer label is to be read by the manual barcode reader before loading. The
bottle is filled with Rinsing Solution (purified water) before start. It can be refilled during
processing without disconnecting the tubing.
The Rinsing Solution is pumped into the Rinse Buffer Bottle, located behind the Processing
Chamber, and from there to the rinse areas, described in Rinse . Rinse solution used by the Left
Arm pipette is pumped to a Shoulder buffer cup located at the rear of the Left Arm.
Processing Chamber
The Processing Chamber consists of two parts, the Immuno Reaction Chamber for the Immuno
Reaction and the Enzyme Reaction Chamber for the Enzyme Reaction. The Processing Chamber
is protected with a cover.
On top of the cover over the Immuno Reaction Wheel is a space for dilution plates.
IC: ImmunoCAP/EliA well in
pw: Pre wash
S: Sample in
sw: Sample wash
C: Conjugate in
cw1: Conj wash 1
cw2: Conj wash 2
cw3: Conj wash 3
DI: Development Solution to ImmunoCAP
DE: Development Solution to EliA well
St1: Stop Solution 1
E: ImmunoCAP/EliA well Ejection
Note: pw, cw2, cw3, st2 and st3 not made for EliA well.
Incubation Chamber (the right side)
The ImmunoCAP/EliA well is dispensed in the Immuno Reaction Wheel. Here it is pre-washed,
and then the sample is pipetted. The sample incubation (the reaction of the specific antibody in
the serum with the antigen in the solid phase) and the conjugate incubation (the reaction of the
specific antibody from the serum with the enzyme marked antibody) takes place in the right
compartment. The chamber temperature is set to 37 C.
The Incubation Carousel moves one step forward every minute.

After the conjugate wash the ImmunoCAP/EliA well is moved to the Enzyme Reaction Wheel
by means of the ImmunoCAP Transfer.
Development Chamber (the left side)

The Development (the reaction of the enzyme marked antibody and the development solution)
takes place in the left compartment. Stop Solution is added and the eluate/reaction product is
aspirated into the Fluorometer. The chamber temperature is set to 37 C.
After the eluate/reaction product has been aspirated into the fluorometer the used
ImmunoCAP/EliA well is ejected and the Elution Well rinsed.
The Enzyme Reaction Wheel moves one step forward every minute.
Fluorometer
The Fluorometer is located in the Enzyme Reaction Chamber . The eluate/reaction product is
aspirated into the Fluorometer Cuvette and the fluorescence is read. The Cuvette is rinsed after
each measurement.
Waste Handling
The waste to take care of is of three kinds:
Fluid Waste
Solid Waste
Used ImmunoCAP/EliA Well Carrier
Fluid Waste Container

One Fluid Waste Container of 20 l is connected at the rear of the instrument.
As an option the waste can be connected to an external waste system.
Solid Waste Container

The Solid Waste Container is located on the shelf underneath the instrument. It is a metal frame
holding a plastic bag or a container that collects used ImmunoCAP/EliA wells and used
ImmunoCAP/EliA Well carriers. ImmunoCAP/EliA wells are transfered to the container by
means of an ImmunoCAP Ejector in the Processing Chamber.
Empty ImmunoCAP/EliA Well Carrier

The empty ImmunoCAP/EliA well Carrier can be transported from the Carrier Storage, either
to the Solid Waste Container, or to an empty Carrier Loading Tray . In either case by means of
the ImmunoCAP Carrier Transport Unit .
The alternative is set in Set Empty ImmunoCAP Carrier.
Wash/Rinse/Waste Compartment
It is recommended to use the shelf on the provided table for the Wash and Rinse Bottles, and for
the Fluid Waste Container.
Wash/Rinse/Waste Connectors
The Wash/Rinse/Waste Connectors are located at the rear of the instrument.

The bottles should be prepared before the start of an assay.
Wash/Rinse System
Wash
The instrument performs 3 respectively 4 washing functions during the assay:
Pre Wash (not done for EliA)
Sample Wash
Conjugate Wash (3x for ImmunoCAP, 1x for EliA)
Sample and Conjugate Pipette
Rinse
Rinse Solution is used for rinsing critical components after each ImmunoCAP/EliA well. The
rinse areas are:
Stop and Development Solution Pipette
Fluorometer Cuvette
Elution Wells
It is also used for rinsing the whole liquid system at the end of the assay run.
Buffer Bottles
The Buffer bottles for Wash and Rinse Solution are located behind the Processing Chamber to
the left of the instrument. The volume can be checked through openings.
Buffer volume for Wash and Rinse is 300 ml.

Power Supply
On/Off Switch
The Primary Power switch is located on the right side near the rear of the instrument.
The Primary Power switch has built-in automatic fuses.
System Power
The System Power switch is a green button, located on the right side of the instrument. The button
is lit up when the power is on.
Note: The Power might be on even if the button is not lit up.
Fuse
Phadia 250 has one automatic fuse, built into the Primary Power switch. If the fuse has released
something is wrong in the instrument. It is not resettable by the user, a Phadia representative
must be contacted.
Warnings
Attention Light
On top of the instrument there is an attention light in order to determine the status of the
instrument.
Green Working (Processing is OK).
Yellow The instrument needs attention by the operator. Some reloading

of reagents may be required, and the dispensing of
ImmunoCAP/EliA well could have been stopped.
Red Error. The instrument needs some corrective action by the

operator.
Sound Alarm
If the sound alarm is set, it will be activated in combination with the red or yellow attention light.
The instrument needs some corrective action by the operator.
Table
Phadia 250 is delivered already standing on its table.
The Wash/Rinse/Waste Compartment is located at the lower part of the table. You have access
to it from the front. The compartment is rested on a slide bar and is easy to pull out for full
accessibility.
Underneath the table are four wheels. They are used for moving the instrument. This should not
be done by the user alone. It is very important that the instrument is installed properly; the levelling
is of outmost importance. If the instrument has to be moved to another location, contact your
Phadia 250 Instrument Software

The software is divided into 3 main parts:
Assay: Check and confirm loading of reagents, and start the assay.
Load: Takes you to the Inventory Display, where you can load reagents and samples.
Utilities: Maintenance and Test programs, Service Programs, and Shut Down. Functions with
Green links have no display of their own, but will take you to the Keyboard Screen or the
Numerical Keyboard.
Instrument Screens
Start Menu
Assay
Press ASSAY to load reagents and start the assay. The Select Method Screen will open.
Load
Press LOAD to select various reagent- and consumable screens, where you can check volumes
and load new reagents.
Utilities
Press UTILITIES to go to the Utilities screen, where you can perform maintenance and set
parameters.
Information
Consists of three different screens:
1. Temperature Monitor
2. Error List
3. System Parameter Settings
Message
If there are any messages this key becomes active. Press the MESSAGE key to display the
message.
Version information
Software Version
The instrument software version is presented on the main screen.
Assay - Method
Include in run
All methods with a button that is switched to blue will have Curve Controls or a new Calibrator
Curve included in the run. Click on the button to switch it on/off. The number of fields is
depending on methods active in IDM.
Note: This feature will not be visible if there are more than 6 active methods in instrument.
Method
The name of the method is presented here. It is possible to run ImmunoCAP and EliA methods
in the same run.
Calibration Type
Calibration Type is automatically defined:
Curve Controls: If a valid calibration curve exists only CC's are requested.
Calibrators: Required if no valid calibration curve exists.
The number of days until next Calibration Curve must be run is presented below this field.
Change Calibrator
You can change the Curve Control to Calibrator by pressing the check box.
Note: This is only possible if there is a valid calibration curve available for the method.
Next
NEXT takes you to the Reagent To Load screen.
Print
By pressing PRINT a command is sent to IDM to print a Load List.
Load
Here you can select various reagent- and consumable screens, where you can check volumes and
load new reagents.
Back
BACK takes you back to Start Menu.
Reagent To Load
List of Reagents need to Load
These reagents have to be loaded before you can start the assay.
List of Reagents recommended to Load

These reagents should be loaded before you start the assay but it is not necessary.
Arrow Keys
With these keys you can go up and down in the lists, if the number of required/recommended
reagents are more than 7.
Next
NEXT takes you to Waste/Rinse/Wash Bottles check.
Previous
PREVIOUS takes you back to Assay - Method .
Load
Here you can select various reagent- and consumable displays, where you can check volumes
and load new reagents.
Back
BACK takes you back to Start Menu . You have to confirm in the Confirm Dialog Box.
Wait Refill
This screen will only be presented if there are tests listed in the Reagent to Load screen under
Reagents Recommended to Load and the user does not load the recommended tests before the
assay starts.
From the error message displayed it is possible to enter this view and select the tests that you
want to perform waiting refill for. Then it is possible to load the selected tests in the load tray
during assay. Tests that are not selected will not be executed (i.e. Test Pass).
Note: Wait refill is available for patient tests. It is not applicable for QC tests. All relevant
ImmunoCAP and/or EliA wells must be loaded before the assay starts in order to perform QC
tests.
Wait Refill
Press WAIT REFILL to perform wait refill on the selected tests.
Back
BACK takes you back to Reagent to Load .
Expired Reagents
This screen will only be presented if there are expired ImmunoCAP in the storage. You can mark
a test name if you want to use that ImmunoCAP in the next assay run even though the expiration
date is passed.
Next
NEXT takes you to Waste/Rinse/Wash Bottles check.
Previous
ImmunoCAP and EliA in Same Run

There are two active technologies: ImmunoCAP and EliA.
It is possible to run both technologies within one run. In this case either ImmunoCAP or EliA is
run first (selectable).
Accordingly, the other technology is run as the second technology.
Both technologies will be divided by a gap (30 empty positions if technology changes from EliA
to ImmunoCAP, 15 empty positions if changed from ImmunoCAP to EliA).
Start with
Select the technology to be used first when processing (ImmunoCAP or EliA).
Change Technology
Select method for the technology change.
Automatically: The instrument will process all start technology tests according to the selection
made under Start with above. The instrument will then automatically change to the second
technology.
Manually: The instrument will wait for an operator command before changing the technology.
Previous
Start
The Assay starts with Assay Initializing.
Waste/Rinse/Wash Bottles Check

This screen is just a suggestion to empty Waste Containers, and to fill Washing and Rinse Solution.
Load
load new reagents.
Previous
Start
The Assay starts with Assay Initializing .
Back
BACK takes you back to Start Menu.
Information
INFORMATION takes you to Information, which consists of three different screens:
1. Error list
Message
If there are any messages this key becomes active. By pressing it the message will be displayed.
Abort Loading
OK
OK takes you back to Start Menu.
Cancel
CANCEL takes you back to Waste/Rinse/Wash Bottles check .
Assay Initializing
The initializing procedure takes about 35 seconds (the instrument functions move to home
positions).
Then the instrument automatically moves on to Assay Priming.
Pause - Continue
When PAUSE is pressed, the initializing stops immediately. The key changes to CONTINUE.
When CONTINUE is pressed, the process continues.
Abort
Abort of Initializing
When ABORT is pressed, the initializing stops and a dialogue box pops up.
Confirm Dialog Box

OK: The initialization is aborted, back to the previous menu.
Cancel: Closes the dialog box, and the process continues.
Assay Priming
The Priming takes about 8 minutes.

After the priming is done it automatically moves on to Blank Run .
Pause - Continue
When PAUSE is pressed, the Assay priming stops immediately. The key changes to CONTINUE.
Abort
Abort of Assay Priming
1. When ABORT is pressed, the priming stops immediately and a confirmation window pops
up.
2. Confirm Dialog box
OK: The priming is aborted. Back to Start menu
Cancel: Closes the dialog box, and the process continues
Blank Measurement
Blank Measurement Information

Measure Technology
The screen appears if ImmunoCAP and/or EliA technology is included in the blank measurement.
Included technology is marked with a blue radio button.
Rinse Blank
1. In the first field the measured value is displayed.
2. In the second field, if it is OK or Not OK.
3. In the third field the upper limit is displayed.
Reagent Blank
The blank measurement results are presented as millivolts. The values are added in real time as
the measurement goes on. If they are within the limits they are flagged as OK.
Pause - Continue
If PAUSE is pressed the blank measurement stops immediately. The key changes to CONTINUE.
Abort
Abort of Blank Measurement
When ABORT is pressed, the blank measurement stops immediately and a confirmation window
pops up.
Confirm Dialog box

OK: The Blank Measurement is aborted. Back to Start menu.
Back
Key not active.
Remeasure
By pressing REMEASURE a new Blank Measurement starts.
Note: This option is only available if the blank measurement is out of specification.
Accept
By pressing ACCEPT, you accept the Blank Measurement, even if the result is out of specification.
Note: This button is only available if the blank measurement is out of limits.
Information
1. Error list
Assay Processing
Assay Status
Assay Status during Assay Processing:
Running
Pause/Stop Sample(s)/Stop (ImmunoCAP/EliA)
Assay Status after END ASSAY has been pressed:

Stop Sample(s): Assay ends after all loaded samples have been processed.
Stop ImmunoCAP/EliA: Assay ends after all loaded ImmunoCAP/EliA wells has been
processed.
Active Technology
Displays the technology currently active (ImmunoCAP or EliA).
Change Technology
It is possible to change technology from ImmunoCAP to EliA, or reverse, manually.
A confirmation window will appear. Press OK to confirm manual change of technology.
Assay Run List

In the assay run list you can see the status of each individual test that is performed in the assay
run.
No.: Sequence number in the Assay
Id: A combination of Curve Control - Calibrator - Sample Id
Method: Short name of method
Test: ImmunoCAP/EliA well short name
Dilution: Marked with instrument diluton factor if the sample is diluted
Time: End time
Process Status: The last performed physical step is shown.

Not started
ImmunoCAP/EliA well dispense
Pre-wash
Sample pipetting
Sample Wash
Conjugate pipetting
Conjugate wash 1
Conjugate wash 2
Conjugate wash 3
Development solution pipetting
Stop Solution pipetting
Elution
Measurement
ImmunoCAP/EliA well eject
Elution well wash
Load Reagents
Allows you to load some of the reagents during the assay processing:
Carriers
Sample racks
End Assay
When you have pressed END ASSAY, and selected Rinse Options, the button END ASSAY
changes its function to CANCEL TERMINATION.
Use the Toggle Key to change key functions.
Pause - Continue
When PAUSE is pressed, dispensing of ImmunoCAP/EliA well is paused.
The key changes to CONTINUE. When CONTINUE is pressed, the process continues.
Extra Calibrator/CC
Allows you to add extra calibrators and curve controls (CC) during the assay processing.
Note: This requires that a calibrator strip or CC strip is already loaded on the instrument.
Information
INFORMATION takes you to Information, which consists of three different displays:
1. Error list
Add Extra Calibrator/CC
It is possible to add extra CC (Curve Controls) during the assay processing in order to check the
Calibration Curve. You can also add extra calibrators to make a new calibration curve. This
requires that a sufficient amount of these reagents has been loaded before starting the assay.
Method Selection
It is possible to select a new Calibrator or Curve Control if the boxes are not gray.
Calibrators
Select Method: Click the radio button for the method you want to add extra Calibrators for. The
button will be blue when selected.
Curve control
Select Method: Click the radio button for the method you want to add extra Curve Controls for.
The button will be blue when selected.
Add
Only active after having selected a method. If Calibrators/CC are already loaded you will come
back to Assay Processing , otherwise to Load Reagents .
Back
Back takes you back to Assay Processing.
Sample Load Rack Information
This screen appears when a sample rack is loaded.
barcode Area
Rack Barcode
Id of the Sample Rack or QC rack.
Sample Position
Tube Position in the Rack.
Sample barcode
The barcode of the sample or Quality Control.
If the field is red there is an error in the barcode reading. Try again using the RELOAD button
or enter the barcode manually by clicking in the red field.
This field is empty if the rack position is empty or if the instrument is set to Rack in barcode
Settings.
Confirm
Takes you back to the previous screen.
Reload
If you have loaded a sample rack, but want to unload it again, you can unlock the rack with this
function.
Back
Not active.
Assay Termination - Select Options

When you have pressed END ASSAY in Assay Processing, the End assay choice and Rinse
option is displayed. The key END ASSAY changes its function to CANCEL TERMINATION.
End Assay Choice

When to end an assay, by default the alternative is:
End after all loaded samples are processed
There are two other alternatives:
End after dispensed ImmunoCAP/EliA wells are processed
Abort immediately (A Service password is required)
Rinse Option
Rinse Pattern, by default the normal rinse option is selected, but you can also select to stay in
primed (Standby) state.
OK
By pressing OK your selection will be executed. You will come back to the Assay Processing
screen. The END ASSAY key has changed to CANCEL TERMINATION.
Cancel Termination
By pressing this key the previous termination is cancelled.
If you select Primed (Standby) the following message will be displayed:
OK
Press OK to finish without rinse.
Cancel
CANCEL closes the popup and returns you to the previous display where you can make another
selection for assay termination.
Post Processing - End Assay Procedure
The Post-processing takes 25 minutes and consists of a rinsing of the liquid system.
Rinse Status
The count down line is gray from the beginning, and it says 25 min. As the processing continues
the line changes colour to blue.
When the post-processing is completed the system power is switched off, if that option has been
chosen.
Pause - Continue
When PAUSE is pressed, the post processing stops immediately. The key changes to CONTINUE.
Abort
Abort of Post Processing
When ABORT is pressed, the post processing stops immediately and a dialogue box pops up.
Confirm Dialog box

OK: The process is aborted. Back to the previous menu.
Utilities
Service
This function is for service purpose only, and requires a service password.
Parameter Settings
You need a password to get access to Parameter Setting. Parameters for operation mode, sample
tubes, barcodes etc can be set by the operator.
User Maintenance
Here you can perform Priming, Blank Measurement, Initialization, Daily-, and Weekly rinse,
and Monthly maintenance.
Superuser Maintenance
You need a password to get access to superuser maintenance. You can perform various testing,
cleaning, settings, and readings.
Shut Down
The system power is switched off. The cooling of the storages remains.
Tool
For Service purpose only.
Assay
Press this button to load reagents and start the assay. Takes you to Select Method.
Load
Press this button to select Load Reagents. Here you can check and confirm loading of reagents:
Conjugate
ImmunoCAP/EliA well
Calibrators
Stop Solution
Check and confirm emptying of Waste Containers
Load Sample Racks
Shut Down
OK
Press OK to switch off the instrument immediately.
Cancel
Takes you back to Utilities .
Load Reagents
You can reach the Load Reagents screen from:
Start Menu
Assay - Select Method
Reagent Loadlist
Utilities
Assay Processing
load new reagents.
The screens are:
Waste/Wash/Rinse Bottles
Diluent Tray
Strip Tray
Development/Stop Solution Information
Conjugate Tray
Carrier Loading Tray Information
Carrier Storage Information
If you have entered Load Reagents from Assay Processing you can load:
Wash Solution
Rinse Solution
ImmunoCAP/EliA well Carrier, and Samples/QC.
When Carriers are loaded, there will be a one minute gap in the process for each carrier to load.
You can read the loading information for all reagents with the barcode reader.
In the Carrier Storage Information screen you can see the number of free positions.
You can open the individual reagent loading screens by pressing them, or by reading a barcode
on a vial, bottle or strip, and the screen will appear.
Assay
ASSAY is only active when you have selected this menu from the Start Menu. The key takes
you to Assay Method .
Load
LOAD takes you back to the Start Menu .
Utilities
UTILITIES is only active when you have selected this menu from the Start Menu. The key takes
you to Utilities .
Waste/Wash/Rinse Information

Shows, by different colors, if the fluid waste container is in use or full.
Wash/Rinse Solution
Shows the status of the washing- and rinse solution distribution.
Main Bottles
Shows, by different colors, if the main bottles are in use, empty or if the Washing Solution has
expired.
Buffer Bottles
When the buffer bottles are both filled it is by indicated by a tick for both Upper and Lower.
Low is always ticked
Upper is ticked when it is filled
When the liquid is used, upper becomes unticked, and the buffer bottle is automatically filled
again.
If the tick never occurs for a bottle indicates a problem in the liquid distribution.
Wash bottle ID Field

When you read the wash bottle ID with the Manual barcode Reader , the ID is presented. It is
also possible to enter the ID manually, by using the Alpha-Numerical Keyboard.
Expiration Id Field
The field shows the date of expiration of the washing solution. If you have accepted to use it
after expiration date by means of EXPIRATION SETUP, there will be an asterisk in the column
State.
Expiration Setup
You can mark Washing Solution that are beyond expiration date and then it will be possible to
use it anyway.
ID Delete
Removes the ID information from the Wash bottle ID Field.
Back
BACK takes you back to the previous menu.
Diluent Information
Diluent Vial Information
You can easily see in the graph which vials that are empty, full, in use or not loaded, by the
different colors.
Diluent bottle ID Field

When you read the diluent bottle ID with the Manual barcode Reader , the ID is presented. It is
also possible to enter the ID manually, by using the Alpha-Numerical Keyboard.
Diluent Information Field

Use the arrow keys to view all columns.
Checkboxes: Tick to select a bottle
No: Vial position number
Status: No Bottle, Full, In Use, Empty
Type of Diluent: The identity of the loaded bottle
Doses (ImmunoCAP): Remaining number of possible doses
Doses (EliA): Remaining number of possible doses
Lot no.: Lot number
Expiration date: Expiration date
State: 'OK' is displayed in this column if you accept to use the diluent
beyond expiration date
Expiration Setup
You can mark a diluent vial that is beyond expiration date and it will be possible to use it.
Unload
UNLOAD unloads all positions, and they will be set to Not loaded.
Dilution Well
Takes you to Dilution Well Information.
Select Empty
By pressing SELECT EMPTY all empty positions will be marked, and then pressing UNLOAD,
the position(s) will be set to Not loaded.
Select Expired/Error
By pressing SELECT EXPIRED/ERROR all those positions will be marked, and then
EXPIRATION SETUP, the position(s) will be accepted for use.
Level Detection
Level detection is used to detect the level and calculate the remaining number of doses for each
vial.
Back
Dilution Well Information
Dilution Well Information

Shows, by different colors, if the wells in the dilution plate are in use, has been used or if no
dilution plate is loaded.
Clear
CLEAR is only active when a plate is loaded. Press CLEAR to set all positions to Not used.
Back
Strip Information
Strip Position Information
In the graph to the left, the status of each individual strip position is indicated by different colors.
ID Fields
Strip Tray ID
Id of the Strip Tray .
Strip ID
Id of the Calibrator/CC Strip.
Strip Information Field

Use the arrow keys to view all columns.
Checkboxes: Tick to select a strip
No: Position
Status: Full / In use / Empty
Type of Strip: Method - Calibrator/CC
Lot No.: Lot number
Exp. Date: Expiration Date
State: Accepted beyond expiration date
Accumulated time: Accumulated time that this strip has been on the instrument,
since it was loaded onto the strip tray
Loaded day: Days since the strip was loaded onto the strip tray
Select Empty
By pressing SELECT EMPTY all empty strips will be marked in the Strip information field.
By pressing SELECT EXPIRED/ERROR all expired, or strips with error, will be marked in the
Strip information field.
Unload
By marking a row in the Strip information field, and then press UNLOAD, the position will be
set to Not loaded.
Use the ToggleKey to change key functions.
Other Tray
You can view information of other defined trays. Select Strip Tray screen opens. The software
can store the information for up to 5 different strip trays.
Expiration Setup
You can mark a strip that are beyond expiration date, or SELECT EXPIRED/ERROR, press
EXPIRATION SETUP and it will be possible to use it.
Delete Well
If a curve control strip with used wells is loaded then these positions must be deleted in the
software.
Mark the curve control strip in the Strip Information screen and press the DELETE WELL button.
Each press on the button will delete one well.
Back
Select Strip Tray
Strip Tray barcode

Read, or enter the barcode of the tray you want to view.
If you select a tray in Strip Tray Selection Field the actual barcode is displayed.
Strip Tray Selection Field

You may select a tray by pressing the row.
Strip Information
Opens Strip Information screen for the selected tray.
Back
Development/Stop Solution Information
Bottle Positions Graph

This graph shows the status of each stop solution bottle and each development solution vial by
using different colors.
Information List
The same for both Development and Stop Solution. Use the arrow keys to view all columns.
In this list you will find information about Stop Solution:
Stop bottle ID: Shows the ID for the selected bottle
No: Position number in Dev/Stop Solution compartment
Status: No bottle, Full, In use, Empty, Expired/Error
Doses (ImmunoCAP): Number of tests that can be performed with remaining Stop
Solution
Doses (EliA): Number of tests that can be performed with remaining Stop
Solution
Lot Number: Lot number
Expiration Date: Expiration Date
State: Stop Solution allowed to be used beyond expiration date
Unload
By pressing UNLOAD a confirm dialog box appears.
OK: All positions will be set to No bottle.
Cancel: Closes the Dialog Box.
Expiration Setup
You can mark a vial that is beyond expiration date and it will be possible to use it.
Level Detection
Can be used after you have loaded, before a new assay. This function detects the level in all
bottles and calculates the volumes and possible number of tests.
Back
Conjugate Information
Conjugate Tray Information
Status: Loaded, Not loaded
Conjugate Vial Graph

This figure shows the status of the 6 different conjugate positions by using different colors.
ID Fields
When reading the ID with the manual barcode reader, the ID is presented. It is also possible to
enter the ID manually, by using the Alpha-Numerical Keyboard.
Conjugate Tray ID: ID of the Conjugate Tray
Conjugate bottle ID: ID of the Conjugate bottle
Conjugate Information List

This list gives you information about the Conjugate stored in the instrument:
No.: Conjugate Position No.
Status: Not loaded, Full, In use, Empty, Expired
ID: The identity of the conjugate
Quantity: The remaining number of tests that can be carried out
State: Accepted beyond expiration date
Accumulated time: Time loaded on instrument
Loaded day: Days loaded in tray
Select Empty
By pressing SELECT EMPTY all empty positions will be marked in the Conjugate Information
Field.
By pressing SELECT EXPIRED/ERROR all expired, or wells with error, will be marked in the
Conjugate Information Field.
Unload
Mark a position by pressing it and press UNLOAD. A confirm dialog box appears.
OK: Selected position will be set to Not loaded.
Cancel: Closes the Dialog Box.
Other Tray
You can view information of other defined trays. Select Conjugate Tray screen opens.
The software can store information for up to 5 different conjugate trays.
Expiration Setup
You can mark a conjugate bottle that is beyond expiration date and it will be possible to use it.
Level Detection
This function detects the level in all bottles and calculates the volumes and possible number of
tests.
Back
Select Conjugate Tray
Conjugate Tray barcode

ID of the Conjugate Tray.
Conjugate Tray Selection Field
No: Conjugate Position No.
Loaded: Loaded or Not Loaded
Tray ID: ID of the Conjugate Tray

Bottle Information
Opens Bottle Information screen for the selected tray.
Back
Carrier ID
The ID of the carrier and expiration date.
Carrier Loading Tray Graph

This graph has two functions. The circles show the status of each individual ImmunoCAP
Carrier/EliA Well by using different colors.
The circles below the tray show the status of the present Loading Tray by using different colors.
If the LED is green the loading tray can be removed. If the LED is yellow the loading tray is in
use and locked.

This screen gives you information about the ImmunoCAP and/or EliA well Carrier in the loading
tray.
No.: Position number on the tray
Test: Short name
Status: Not loaded, Full, In use, Empty, Error/Expired
Amount: Number of remaining carriers
Lot specific: Lot specific code (For EliA)
Use expired: Accepted beyond expiration date
Days loaded: Number of days that the carrier has been loaded
Start Transfer to Storage/Lock Loading Tray

Starts the loading of ImmunoCAP/EliA well Carrier from the loading tray to the Carrier Storage.
The button will change to LOCK LOADING TRAY if the loading tray was unloaded.
Press LOCK LOADING TRAY to prevent the transfer of ImmunoCAP carriers from the loading
tray to the storage tray.
Edit Doses
Allows you to manually enter the number of ImmunoCAP/EliA wells in a carrier.
Clear Tray
All position will be set to Not Loaded.
Note: Active only when the Loading Tray is not loaded on instrument.
By clicking the Toggle Key the Action Keys change.
Unload
The tray will be unlocked and can be unloaded. Dispensing is aborted.
Expiration Setup
Mark ImmunoCAP/EliA well Carriers, so they can be used although they have passed expiration
date.
Scan Load Tray

All Carriers are scanned by the barcode reader and are put back on the loading tray. The loading
tray is locked after the scan is completed.
Note: ImmunoCAP/EliA Well carrier should only be stored for 24 hours at room temperature
on Carrier Load Tray.
Back
BACK takes you back to previous screen.
Information
1. Error List
Edit Doses
Carrier ID
Displays the barcode on the ImmunoCAP/EliA well Carrier label.
Amount
Displays the number of ImmunoCAP in the carrier. You can edit the number by pressing this
field, and enter a new value by means of the Numerical Keyboard.
Barcode Reading
The radio button is by default blue for barcode reading. By unchecking it (becomes white) the
automatic reading is disabled and it will be possible to use ImmunoCAP/EliA well Carrier with
a damaged barcode.
OK
OK confirms your new value, and takes you back to the Carrier Loading Tray Information
screen.
Cancel
Closes the Edit Doses box.
Sample Tube Information

The sample rack graph shows the status for all sample tubes and QC vials in the different sample
and QC racks, by using different colors.
The LED-symbols below the sample racks corresponds to the LED's in the sample loading area.
Sample Rack Information Field
Information of each individual sample rack:
Position No: Sample rack lane
Sample Rack ID: The barcode on the rack
Status: Not loaded, Not started, Pipetting, Completed, Error
Type: Sample, QC
Sample Information
Select a sample rack in Sample Information Field, and then press SAMPLE INFORMATION,
Sample Information screen opens.
Unload Rack
To unload a rack before pipetting is completed, select a sample rack in Sample Information Field,
and then press UNLOAD RACK.
Note: If there are tests started in the process for this rack, unloading of the rack will not be
possible until sample has been dispensed for the tests.
Back
BACK takes you back to Load Reagents.
Sample Information
Sample Rack Position/ID Fields
Identifies the selected rack, position in Sample Loading Area and sample rack ID.
Sample Information List

Information about each sample tube in the selected rack:
No: Position in the rack
ID: Barcode on the sample tube
Testname: Name of the requested test
Status: Not loaded, Not started, Pipetting, Completed, Error
Dilution factor: Dilution factor
Priority: Indication in this column means high priority (from IDM)
Back
BACK takes you back to Sample Rack Information.
Carrier Storage Information

Carrier Status
Checkboxes: Tick to select a test to unload
Pos: Position in the tray
Status: OK, Empty, Error/Expired
Test name: Short name
Amount: Remaining number of ImmunoCAP/EliA well
Lot number: Lot number
Lot specific: Lot specific code (For EliA)
Use expired: Allowed to use beyond expiration date
Days loaded: Days loaded on instrument
Tray No.: Number of the storage tray
Select Empty Items

Selects all empty ImmunoCAP/EliA well Carrier.
Select Low Frequent Test
Selects all low frequent tests.
Unload
Unload selected ImmunoCAP/EliA well Carrier.
By clicking the Toggle Key the Action Keys change.

Takes you to Carrier Storage Tray.
Expiration Date
Handle Carriers that are beyond expiration date.
Selects all ImmunoCAP/EliA well Carrier that has expired or have failed to dispense.
Back
Information
1. Error List

Storage Graph
Shows the three storage tray positions inside the instrument and their status.
No Tray loaded
Tray loaded
Barcode Information Field

Shows the Tray ID for the selected tray.
Carrier Storage Tray information Field

Shows the properties for all defined storage trays:
No: Sequence number of defined trays
Tray Pos: Position in the storage
Tray ID: Barcode
ImmunoCAP/EliA well The type of ImmunoCAP or EliA well that are allowed to be
loaded on this tray.
Carrier Group defined:
Group numbers can be defined for each type of ImmunoCAP
or EliA well in the method screens in IDM
Load/Unload
Load: Only possible if there is an empty position in the storage.
1. Select a not loaded tray from the list.
2. Press LOAD/UNLOAD and the empty position moves to the load/unload position.
3. Read the tray barcode and place the tray in position.
Unload:
1. Select a tray by pressing the sector or line.
2. The selected sector will be moved to load/unload position.
Tray Info
Opens the Carrier Storage Tray Information screen.
Note: Only active if you have selected a tray.
Clear
Note: Only active if you have selected a tray. The tray will be cleared and all positions set to
Not Loaded.
Back
Information
INFORMATION opens the Information screeb, which consists of three different displays:
1. Error list
Carrier Storage Tray Information

Presents the information of a selected Carrier Storage Tray.
Tray Properties
Tray Position: Position in the Carrier Storage.
Tray ID: Barcode of the Carrier Storage Tray.
Carrier Information List

Pos: Position in the tray
Status: OK, Empty, Error/Expired
Testname: Short name
Amount: Remaining number of ImmunoCAP
Lot number: Lot number
Lot specific: Lot specific code (EliA)
Use: Allowed to use beyond expiration date
Days loaded: Days loaded on instrument

Back
Information
Information consists of three different screens:
1. Error List
Error List
Error Information List
Date/Time: Date and time when the error occurred
Error/Warning: Type of Error
Error No.: Error Code
Information: Message Field in the Alert Display
Error Release: Key used to close the Alert Display

System Parameter Settings
It is possible to see the present settings, selected in Parameter Setup , anytime.
Temperature Monitor
It is possible to see the actual temperatures anytime.

Temperature Sensors
Sensors are located in:
Incubation Chamber
Development Chamber
ImmunoCAP/EliA well Carrier Storage
Conjugate Compartment
Fluorometer
at the top of the instrument for the ambient temperature
The actual time and instrument IP adress are also displayed.
Service
Service Key is only for by Phadia trained service engineers. You need a password to get in.
Maintenance Programs
This chapter describes the different Maintenance program screens. For detailed information about
how to run these Maintenance procedures, please se chapter Maintenance.
All started maintenance runs are automatically logged in IDM. This function can be disabled by
a service engineer. If the maintenance has not been performed a warning will be presented when
the instrument starts up.
The Maintenance Programs are organized in two blocks:
1. User Maintenance
2. Superuser Maintenance
User Maintenance
Touch Screen
You select what to do by pressing:
PRIME
BLANK MEASUREMENT
INITIALIZE
DAILY RINSE
WEEKLY RINSE
MONTHLY MAINTENANCE
Back
Information
1. Error List
Prime
Start
By pressing START the priming starts. The START key is replaced by PAUSE and the middle
key to the left becomes an ABORT-function.
Pause - Continue
When PAUSE is pressed, the priming stops immediately. The key changes to CONTINUE.
Abort
Abort Priming
When ABORT is pressed, the priming stops immediately and a dialogue box pops up.
Confirm Dialog Box

OK: The priming is aborted, back to the previous menu.
Back
Information
1. Error List
Blank Run
This function is the same as Blank Measurement during initializing of an assay.
Measure Technology
Selection of technology, ImmunoCAP or EliA Well.
Start
By pressing START the blank run starts. The START key is replaced by PAUSE and the middle
key to the left becomes ABORT.
Pause - Continue
When PAUSE is pressed, the blank run stops immediately. The key changes to CONTINUE.
Abort
Abort of Blank Run
When ABORT is pressed, the blank run stops immediately and a dialogue box pops up.
Confirm Dialog Box

OK: The blank run is aborted. Back to the previous menu.
Back
Information
1. Error List
Initialize
The same function as during Start Assay Run. (The instrument functions move to home positions.)
Start
By pressing START the initialization starts. The START key is replaced by PAUSE and the
middle key to the left becomes ABORT.
Pause - Continue
When PAUSE is pressed, the initialization stops immediately. The key changes to CONTINUE.
Abort
Abort of Initialization
When ABORT is pressed, the initialization stops immediately and a dialogue box pops up.
Confirm Dialog Box
Back
Daily Rinse
Shut Down
Select Shut down (becomes blue) if you want the instrument to enter stand-by mode after rinse.
Start
By pressing START the daily rinse starts. The START key is replaced by PAUSE and the middle
Pause - Continue
When PAUSE is pressed, the daily rinse stops immediately. The key changes to CONTINUE.
Abort
Abort of Daily Rinse
When ABORT is pressed, the daily rinse stops immediately and a dialogue box pops up.
Confirm Dialog Box

OK: The daily rinse is aborted, back to the previous menu.
Back
Information
1. Error List
Weekly Rinse
Tick in Shut Down and the instrument will enter stand-by mode off after weekly rinse.
Start
By pressing START the weekly rinse starts. The START key is replaced by PAUSE and the
Pause - Continue
When PAUSE is pressed, the weekly rinse stops immediately. The key changes to CONTINUE.
Abort
Abort of Weekly Rinse
When ABORT is pressed, the weekly rinse stops immediately and a dialogue box pops up.
Confirm Dialog Box

OK: The weekly rinse is aborted, back to the previous menu
Back
Information
1. Error List
Monthly Maintenance
Monthly maintenance means to clean the whole liquid system with a cleaning solution.
Start
By pressing START the Monthly Maintenance starts. The START key is replaced by PAUSE
and the middle key to the left becomes ABORT.
Option Button
If the button Shut down after Monthly Maintenance is switched to blue the instrument will shut
down after the final rinse has been performed.
Pause - Continue
When PAUSE is pressed, the Monthly Maintenance stops immediately. The key changes to
CONTINUE. When CONTINUE is pressed, the process continues.
Abort
Abort of Monthly Maintenance
When ABORT is pressed, the Monthly Maintenance stops immediately and a dialogue box pops
up.
Confirm Dialog Box

OK: The Monthly Maintenance is aborted, back to the previous menu.
Back
Information
1. Error List
Priming (with Cleaning Solution)
Priming with cleaning solution.
Incubation
Incubation with cleaning solution. During this time the Wash and Rinse bottles should be cleaned.
When Wash and Rinse bottles have been filled with Rinse solution it is time to press CONTINUE.
If this is not done in time following Error screen is presented.
Error screen
Finish the cleaning of the bottles press CLOSE and then CONTINUE.
Incubation Time
If the bottle cleaning has been done before the incubation has ended this screen is displayed.
Rinse Time
The rinsing takes place.

After this the instrument will shut down automatically if that option has been selected, otherwise
the User Maintenance screen is displayed.
After the rinsing is completed the Waste bottle should be cleaned.
Super User Maintenance
To get access to this screen, you have to log in as a Super User.

You can select the following by pressing the symbol:
INITIALIZE
FLUOROC MEASUREMENT
FUNCTIONAL TEST
WASHING
VERIFY IMMUNOCAP STORAGE
SAVE RESULT ON USB OR DISKETTE
EJECT IMMUNOCAP/ELIAWELL
TRANSFER IMMUNOCAP CARRIERS BETWEEN STORAGE TRAYS
SENSOR SETTING
Back
Back takes you back to previous screen.
Information
1. Error List
Initialize
The same function as during Start Assay Run. (The instrument functions move to home positions.)
Start
By pressing START the initialization starts. The START key is replaced by PAUSE and the
Pause - Continue
When PAUSE is pressed, the initialization stops immediately. The key changes to CONTINUE.
Abort
Abort of Initializing
When ABORT is pressed, the initializing stops and a dialogue box pops up.
Confirm Dialog Box

Back
FluoroC Run
Barcode Input Field

Barcode is read with the Manual barcode Reader, the reading is displayed here. It is also possible
to enter the barcode by means of the Alphanumerical Keyboard.
FluoroC Information Field

Status
Lot number: Read from barcode
Expiration Date: Read from barcode
Allowed: OK means that it is OK to use the FluoroC vial although it is

beyond expiration date.
Target Value
Read from the barcode.
Start
Starts the FluoroC Measurement. The START key is replaced by PAUSE and the middle key to
the left becomes ABORT.
Expiration Setup
Allows you to use the FluoroC although it is beyond expiration date.
Post Processing Start

Note: Not to be used in this version of Phadia 250.
Back
FluoroC Measurement
Blank Reading
Before the FluoroC Measurement a rinse blank is performed. The values should not exceed the
Upper and Lower limits.
FluoroC Values
The FluoroC Values are measured in three replicates, each presented separately.
Pause - Continue
When PAUSE is pressed, the FluoroC Measurement stops immediately. The key changes to
CONTINUE. When CONTINUE is pressed, the process continues.
Abort
Abort of FluoroC Measurement
When ABORT is pressed, the FluoroC Measurement stops immediately and a dialogue box pops
up.
Confirm Dialog Box

OK: The FluoroC Measurement is aborted, back to the previous menu.
Back
BACK is not active during the measurement. When the measurement is finished it will take you
back to previous screen.
Functional Test
In Functional Test you can select to test the accuracy of the pipettes, the tube settings or the
volume dispensed by the washing stations.
Pipette Test
With the Pipette Test you can test the pipetting accuracy for:
Sample or Diluent using different dilution ratios
Stop Solution using Sample, Blank or FlouroC
Calibrators and Curve Controls using Strip
Conjugate
Start - Pause - Run

By pressing START the Pipette Test starts. The START key is replaced by PAUSE and the
middle key to the left becomes STOP.
When PAUSE is pressed, the test stops immediately.
The key changes to RUN. When RUN is pressed, the process continues.
Stop
When STOP is pressed, the Pipette Test stops immediately and a dialogue box, Abort, pops up.
Confirm Dialog Box

OK: The Pipette Test is aborted, back to the previous menu.
Back
Back takes you back to the previous screen.
Information
1. Error List
Wash Volume Check

Wash Volume Check is started from the Wash Volume Check screen, which also displays the
result from the check.
Start - Pause - Stop
By pressing START the Wash Volume Check starts. The START key is replaced by PAUSE
and the middle key to the left becomes STOP.
When PAUSE is pressed, the test stops immediately.
Back
Back takes you back to the previous screen.
Information
1. Error List
Washing
Select Area
Here you can select a number of different washings to be performed.Press the check box for
wanted washing.
Start
By pressing START the washing starts. The START key is replaced by PAUSE and the middle
Pause - Continue
When PAUSE is pressed, the washing stops immediately. The key changes to CONTINUE.
Abort
Abort of Washing
When ABORT is pressed, the washing stops immediately and a dialogue box Abort pops up.
Confirm Dialog box

OK: The washing is aborted. Back to the previous menu
CANCEL: Closes the dialog box, and the process continues.
Select All
Selects all available washings.
Deselect All
Deselects all selected washings.
Back
Verify ImmunoCAP Storage

The Carrier storage can contain up to 180 Carriers. This function checks that the content of the
storage is according to the ImmunoCAP/EliA well Information List.
Start
START starts the verification of the Carrier storage.
Back
Abort
When ABORT is pressed, the verifying process stops immediately and a dialogue box pops up.
Confirm Dialog box
OK: The verifying is aborted. Back to the previous menu
CANCEL: Closes the dialog box and the process continues.
Pause - Continue
When PAUSE is pressed, the verifying stops immediately and PAUSED! is displayed. The key
changes to CONTINUE. When CONTINUE is pressed, the process continues.
When the verifying process is finished a message "Scan OK" will be displayed if the verifying
process is without deviation from the information list. If there are deviations they will be listed
on the error list. Deviations will be reported if an ImmunoCAP Carrier is missing, if an
ImmunoCAP Carrier is in the wrong position or if an ImmunoCAP Carrier is in a position which
should be empty.
Request Result to diskette/USB
Select File Area

Select the file(s) you want to copy to a diskette or to a portable USB flash memory if the instrument
has a USB-port by pressing the row(s), or use SELECT ALL. You may need to select the drive,
which is the USB-port, on the Microsoft Windows-based system computer.
The fields in the select area are:
Run No
Date
Measure time
Number of data
Start
By pressing START the copying starts.
Select all
Selects all available files.
Deselect all
Deselects all marked files.
Back
Copying results
During the copying none of the keys START, SELECT ALL, DESELECT ALL, BACK,
INFORMATION, or MESSAGE are enabled.
When the copying is completed you will return to the screen Request Result to diskette/USB.
Eject ImmunoCAP/EliA Well

Start
By pressing START the instrument starts to eject all ImmunoCAP / EliA Well from the reaction
wheels. The process takes approximately 25 minutes.
Back
BACK takes you back to the previous screen.
Ejecting ImmunoCAP/EliA Well

Pause - Run
When PAUSE is pressed, the ejecting stops immediately. The key changes to RUN. When RUN
is pressed, the ejecting continues.
Stop
Stop of Ejecting
When STOP is pressed, the ejecting stops immediately and a dialogue box pops up.
Confirm Dialog box

OK: The ejecting is stopped. Back to the previous menu.
CANCEL: Closes the dialog box, and the ejecting continues.
Transfer ImmunoCAP Carriers between Storage Trays

This function is for transferring all ImmunoCAP / EliA well Carrier from one storage tray to
another. The target tray must be empty. The graph over the Carrier Storage Trays is color coded
to show if the three sectors are loaded or not and the direction of the transfer.
Tray Selection
You can select Tray either by pressing the sector in the circular graph, or the row in Tray
Information field
Barcode Reading
Displays the barcode of the Storage Tray.
Tray Information Field

Tray Pos.: Tray position 1, 2, or 3
Tray Id: Barcode of the Tray
Group No.:
Doses left: Number of ImmunoCAP / EliA well Carrier
Start
Starts transfer.
Set from Tray

Mark the tray you want to load from. Press SET FROM TRAY.
Set to Tray
Mark the tray you want to load to (must be empty). Press SET TO TRAY
Use the key to change key function.
Load/Unload
Select position to load/unload.
Back
Sensor Setting
By default all three sensors are enabled.
Disable Sensors
You may disable the sensors:
ImmunoCAP / EliA well Carrier Load Tray Sensor
Conjugate Tray Sensor
Strip Tray Sensor
Confirm
Confirms your settings.
Note: To make the disabling effective you have to reboot the Instrument SW.
Back
ISW Parameter Setting
You need a Superuser Password to get into Parameter Setting

Note: This chapter only describes the different displays in Parameter Setting. How to operate
the different displays you will find in chapter System Configuration/Phadia 250 Parameter
Setup.
ISW Parameter Settings

Parameter Selection
You can set parameters for:
Regional Parameters
Barcode Settings
Tube Settings
Miscellaneous settings
Errors / Warnings Setting
Basic Configuration
Module Settings (Thermostatic setting)
Some parameters have to be set by Service engineers
Blank limits
FluoroC limits
Fluorometer Quotient
Temperature limits
Barcode Settings
Define which barcodes that are used.
Tube settings
Defines the Bottom level and Pipetting depth for Sample tubes, Pediatric tubes and Quality
Control bottles.
Various settings.
Error/Warning
Setting for how Alerts will be attended.
Basic Configuration
Configuration of UPS (Uninterruptible Power Supply) and Low Frequent Tests.
Module
Thermostatic settings.
Register
By pressing REGISTER your setting becomes active.
Service Parameters
Press SERVICE PARAMETERS to get access to the service parameters Blank, FluoroC,
Fluorometer, and Temperature.
Note: For service purposes only. A password is required to get access.
Back
BACK takes you back to the previous menu
Regional Settings
Regional Parameters
Date Format: 1
Date Separator
Time Format
Time Separator
Floating Point
Temperature Unit
Language
Value
By touching the Value column for a certain parameter, a selection display opens. Select option
or enter values via keyboard or numerical keyboard.
Service Parameters
Register
Back
BACK takes you back to Utilities.
Date Format Selection
Confirm
By pressing CONFIRM your selected alternative is active, and takes you back to the previous
display.
Back
BACK takes you back to previous display without changing your setup.
Time Format Selection

Confirm
display
Back
Temperature Unit Selection

Confirm
display.
Back
Language Selection
This is for selecting the language to be used in Phadia 250 Displays.
Confirm
display.
Back
Barcode Settings
Barcode Parameters
Barcode Mode
Sample Barcode
Value
By touching the Value column for a certain parameter, a selection display opens. Select option
or enter values via keyboard or numerical keyboard.
Service Parameters
Register
Back
BACK takes you back to Utilities
Barcode Mode
Confirm
display.
Back
BACK takes you back to previous display without changing your setup
Sample Barcode
Use the Numerical Keyboard to enter the position from where you want the Barcode on Sample
tubes to be used; position 1-16.
Confirm
display.
Back

Use the Numerical Keyboard to enter the maximum number of characters to be used from the
Sample tube Barcode, counted from start position; 1-16.
Confirm
display.
Back
Tube Settings
Settings for Sample Tube and QC bottle dimensions.

For more information about defining correct tube settings, see chapter Phadia 250 Parameter
Setting in System Configuration.
Note: Changes in Tube Settings should only be performed by your sales office.
Register
Back
Miscellaneous Parameters
In Miscellaneous Settings you can change the following parameters:
Waste PipedOut
StartUp Time
SuperUser Password
Conjugate Tray List
Strip Tray List
Default Strip Tray
Screen Saver Time
Report test as completed as soon as a fatale error has occurred for it
Cal/CC Measure: Automatic start
Color Pattern
Wash Volume Check when Starting Assay Run
Value
By touching the Value column for a certain parameter, a selection display, keyboard or numerical
keyboard display opens. Select option or enter values via keyboard or numerical keyboard.
Register
Back
Daily Rinse options after assay.

Note: All checkboxes shall be marked in order to maintain good instrument performance.
Confirm
display
Back
Confirm
display.
Back

Select if empty ImmunoCAP / EliA well Carrier shall be unloaded automatically after the assay
or not.
Confirm
display.
Back

Select if you want Phadia 250 to remain in Stand By Mode, or be powered off after END ASSAY.
Confirm
display.
Back

Select if empty Carrier shall be unloaded to Carrier Loading Tray or disposed to the Waste Bag.
Confirm
display.
Back
Waste PipedOut
Choose if waste liquid shall be collected in the waste bottle or piped out via the drainage on the
right side of the instrument.
Confirm
display.
Back
StartUp Time
Here you can set the time when you want the warm up to start in order to have the instrument
ready in the morning. Select the weekdays and the time to start. (This setting can also be entered
in the IDM - IDM Workplace - Phadia 250 Window - Instrument Tab).
Confirm
display.
Back

You can define certain ImmunoCAP Groups to the different carrier storage trays. Each
ImmunoCAP/EliA carrier has a group number. The Group number for all carriers is default 0
(zero). A carrier can only be loaded into a tray that has a corresponding number. Carrier group
numbers are set for each carrier in IDM.
Confirm
display.
Back
Errors / Warnings Setting

In Error/Warnings you can change settings for all errors, warnings and messages.
Errors, warnings and messages are divided into 5 major groups:
Main
Sub System 1
Sub System 2
Sub System 3
Sub System 4
The following parameters can be changed for each error, warning or message:
Light unit (color signal)
Beep (sound signal)
Back
Error Setting List

This same display is used for all Error/Warning Groups:
Main
Sub System 1
Sub System 2
Sub System 3
Sub System 4
Modify
Opens Error Modify display.
Back
Error Modify
The properties for the selected error/warning/message can be seen in the Error Modify display.
Register
By pressing REGISTER your setting becomes active
Back
Basic Configuration
In Basic Configuration you can change the following parameters:
UPS use, (Uninterruptible Power Supply)
Accept low frequent test from IDM.
Value
By touching the Value column for a certain parameter a selection display opens where you can
do the selection.
Back
UPS Use
If you have connected an Uninterruptible Power Supply (UPS) to the power inlet, set this to Yes.
Confirm
display.
Back

Select if the instrument shall accept requests for Low Frequent test from IDM. Each ImmunoCAP
and EliA test can be defined as Normal used test or Low Frequent used test in IDM, (see IDM
User Manual for more information).
Confirm
display.
Back
Module Settings
In Module you can change the following parameters:
Heater Off Timer
The parameter Heater On/Off (Standby Mode) defines if the shall be used in standby mode or
not.
The Parameter Heater Off Timer defines the time the Heater is on after assay is finished (Standby
mode is initiated).
Back
Numerical Keyboard
The Numerical Keyboard pops up as soon you touch a numerical input field. Just touch a key
to enter information.
Data Name field

Shows the Name of the display where you initiated the Numerical Keyboard.
Limit fields
Shows the lowest and highest values you can enter.
Keys
0 to 9 Numerical keys
. Decimal point
< Moves cursor one character to the left
> Moves cursor one character to the right
BS Removes one character to the left of the cursor
Confirm
display.
Cancel
cancel takes you back to previous display without changing your setup.
Confirm Dialog Box
OK
Saves your settings and returns to Parameter Setting.
No
NO takes you back to Utilities.
Cancel
Cancels your settings and returns to Parameter Setting.
Operation
This chapter mainly contains instructions for Phadia 250 instrument operations performed on a
regular basis. However, operations that you normally do not have to perform are described in
the Unscheduled Operations section.
Maintenance operations are described in the Maintenance chapter, and setup operations can be
found in the System Configuration chapter.
The instructions refer to both the instrument and the Phadia Information Data Manager (IDM).
Start Up - Shut Down
Phadia IDM
Start Up
Always start IDM before powering on the instrument.
1. Switch the IDM computer on and log in. Use the LOGIN - F9 button.
2. Enter User Id and Password.
Shut Down
After work is completed, logout using the LOGOUT - F9 button and shut the computer down.
It is recommended to restart the IDM computer at least once a week.
Phadia 250
The Phadia 250 instrument has two power switches as shown in the figure below. Phadia 250
should never be switched off completely. After the assay is completed, the instrument will enter
stand-by mode with the System Power off and the Primary Power on.
Part Function
1 System Power
2 Primary Power
Start Up
Always start IDM before powering on the instrument.
1. Switch Primary Power on, if it has been turned off.
2. Switch System Power on.
It takes approximately 3 minutes until the Instrument SW starts.
3. Load Rinse Solution and Washing Solution.
Make sure that the Fluid Waste Containers are empty.
Note: Phadia 250 should never be switched off completely, unless required.
Shut Down
Shut Down with filled tubing system
This is done when shutting down the instrument when the instrument has been on for some time,
even though no assay has been performed, or when no rinse has been performed after the assay
was ended.
Note: Phadia 250 should never be switched off completely, unless required.
1. Load Rinse Solution.
Make sure that the Fluid Waste Containers are empty.
2. Unload Reagents and empty bottles.
3. Unload empty ImmunoCAP/EliA Well Carrier.
4. After all reagents are unloaded:
Go to the Start Menu screen on the Instrument by pressing BACK till you get there.
5. On the Start Menu screen, select Utilities.
6. On the Utilities screen, select User Maintenance.
7. On the User Maintenance screen, select Daily Rinse
8. On the Daily Rinse screen, select the Shut down after rinse option button.
9. Press START.
Instrument Rinse takes place. After the rinsing is completed, the instrument SW will shut
down and the system will power off.
10. Switch the Primary Power off, if required.
Shut Down with empty tubing system

This should only be performed under special circumstances, for example before relocation or
shipping of the instrument.
Please contact your local Phadia representative.
Routine Operation
Routine Operation includes all normal steps from loading reagents and samples to reporting of
results.
This section describes the Phadia 250 workflow and operational procedures performed on a
regular basis. You may organize the workflow in the laboratory in the way it best suits your
routines. In the workflow described here, requests are already recorded in a mainframe/LIS, from
where they are automatically imported to the IDM software. If this is not the case, and you need
to, for example, import a request or create a request manually, see the Request Management
section.
Note: This description assumes that the instrument is in Stand-by Mode.
Start Up
1. Switch the IDM computer on and login using the LOGIN - F9 button.
2. Enter User Id and Password.

3. Power on the Phadia 250 by switching the System Power on.
The instrument will be in stand-by mode and it will take approximately 3 minutes for the
Instrument Software (ISW) to start.
Check Request
Check which requests/methods that are to be processed. This is done in the Request List window
in IDM (to get there, click the REQUEST - F2 button in the IDM Workplace).
In this example requests are imported automatically from the LIS.
Check Inventory
Review the reagents needed for the assay run and then highlight all requests to be included in
the run. Use the MENU>> button to activate the menu, and then click the CONSUMABLES
button.
Load Reagents
An overview of the procedure for loading reagents is provided below. For detailed information
on how to load reagents, see the Reagent Management section.
Note: It is important to pop air bubbles in the bottles. Remaining air bubbles might be aspirated
instead of the reagent.
Note: Always mix strips before assay. See the Load CC/Calibrator Strip Tray section.
Note: Wash Volume Check starts automatically at assay start, if the corresponding system
parameter is set to ON.
Note: If Wash Volume Check is included in the assay, load Xummy wells in the Carrier Storage.
20 Xummy wells are needed. It is not sufficient to place them in the Carrier loading tray.
1. Print the loadlist which specifies the amount of items that needs to be loaded.
2. Next step is to load reagents that are short or missing. Loading is done using the Load screen
in the ISW, or from reagent specific load menus.
3. On the ISW Start Menu screen, select Load. The Load screen will appear.
4. Press the Manual Barcode Reader to activate it.
5. Remove the cap from the bottle to be loaded.
6. Check if there are air bubbles in the bottle. Pop any air bubbles using a disposable pipette tip
to avoid contamination.
7. Read the reagent barcode (BC) label. The screen will switch to the reagent specific load screen.
Then load the reagent in the designated (flashing green) position.
8. Press BACK to return to the Load screen.
9. Repeat this procedure for all reagents to be loaded.
Note: If a reagent specific load screen is displayed, the ISW will only accept reagent specific
barcodes. All other read reagents will generate an error message.
Start Assay
Processing starts with Curve Controls and/or Calibrators followed by samples and Quality
Controls. The processing ends with measurement. If the curve controls and/or the calibrator curve
are/is not accepted, the Curve Control Results and/or the Calibrator Results window will
appear. You will then have to take some action for Result Approval.
It is possible to run ImmunoCAP and EliA technology within one run. For more information,
see Mixed Technologies .
Start Assay
1. Press BACK repeatedly to return to the Start Menu window.
2. Press ASSAY.
Result: The Assay Method window opens. An alternative window opens if more than 6
methods are activated.
Note: If more than 10 days have passed since the last Weekly Maintenance, or 40 days since
the last Monthly Maintenance, it will not be possible to start an assay. An error message opens,
informing that maintenance is required.
3. Select the method(s) to be included in the assay.
For the ordinary Assay Method window, select the option button(s) to the left of the method
name.
Result: The button will switch to blue color. All methods with a blue button will be included
in the assay.
For the alternative Assay Method window, press the Method field and select the method
from the drop-list.
4. Calibration type is suggested by the instrument (Curve Controls or Calibrators). If Curve
Controls is suggested, you will see how long it will take until the next Calibration curve is
demanded.
Change calibration type by selecting the Change Cal. option button (blue is selected).
5. Press NEXT to confirm the selections.
Result: The instrument performs an Initial Check to check that all reagents for the selected
methods are loaded.
6. The Reagents To Load screen will appear only when an insufficient number of reagents have
been loaded. The software will display two lists.
a. List of reagents to be loaded

These reagents must be loaded before you can start the Assay. To do so, press the LOAD
key and load the requested reagents.
Note: The list only contains reagents to run Calibrators/Curve Controls and samples already
loaded for selected methods.
b. List of reagents recommended to be loaded
These reagents could be loaded before you start the assay, but it is not necessary. This is
to reach the refill level set in IDM. For more information, see IDM User Manual, the Phadia
250 Instrument/Phadia 250 Configure section.
If you want to load reagents, press the LOAD key and load the requested reagents.
7. Press NEXT to continue.

Note: If expired reagents are loaded, the expired reagents window will appear. For a description
of how to handle expired reagents, see the Handle Expiration Date section.
8. The Check Waste/Rinse/Wash Bottles screen appears.
a. Check that Wash and Rinse bottles are filled with the appropriate solution and volume,
that they are loaded and that tubings are properly connected.
b. Check that the Waste container is empty and loaded, and that the tubings are properly
connected.
9. Press NEXT to start the Assay Run. The instrument will perform Initialization, Priming and
Blank Measurement before the actual assay. Wash Volume Check will also be performed
before the assay, if enabled in the parameter settings.
Note: If you use both ImmunoCAP and EliA technologies in the same run, a message about
this will be displayed before the initialization starts. For more information, see the Mixed
Technologies section.
During initialization, the instrument checks that all motors and mechanical movements are
OK.
During Initialization you can load sample tubes into Sample Racks, either randomly (with a
barcode), or organized (without a barcode).
10. After Initialization, Priming is performed to get fresh Rinse and Wash solutions into all the
tubing of the liquid system.
Time until priming is ready is displayed.

During Priming a Reagent Check is performed, which checks all the different volumes and
tells the number of tests possible to perform. The check will detect if any bottle is still capped.
11. Wash Volume Check is performed after Priming, if enabled in the parameter settings. If the
result is Not OK, an error message will be displayed. Contact your local Phadia representative
for assistance. The test result may be affected.
12. The instruments performs a Blank measurement (Rinse Blank and Reagent Blank) for all
technologies selected in order to avoid unnecessary loss of reagent, and to prevent that an
assay with bad reagents is started.
a. Rinse Blank Checks rinse solution and determines if rinse solution is contaminated.
b. Reagent Blank Checks Development Solution and Stop Solution to determine if
development and stop solution are contaminated.
The instrument will automatically continue if blanks are within set ranges to Assay Processing
(if blank is out of specification it is possible to re-measure by pressing REMEASURE. For
more information, see System Description/Phadia 250 Instrument Software/Blank
Measurement).
13. The assay run will now start.
14. The Assay Processing screen displays information about instrument Status, Active Technology,
if there is a change of technology.
The list shows Identity for Sample/Cal/CC/QC which method, test, dilution (if any), which
time results are expected and which process step is currently performed.
It is not possible to leave this window during the processing, unless you abort it. The only
actions you can take are:
Add extra Calibrators/CC
Check Sample Rack Information
Load missing ImmunoCAP / EliA well
Check Temperatures
Note: The instrument will only start a test if there are enough reagents to finish the test. No
waste of sample.
Load Samples
First, the sample tubes are loaded into Sample Racks. The Sample Racks are then ready to be
loaded into the Phadia 250 instrument. Loading of Samples and Sample Racks are described
more thoroughly in the Sample Management section
You can also prepare a dedicated Quality Control Rack for Quality Controls (QC) in the same
manner. See the Quality Control Management section.
In this example, Sample tubes with Barcodes are loaded.
Note: It is important to always load samples with sufficient volume for all tests to be run including
dead-volume (dead-volume differs from different tubes). It is also important that the correct
sample tube settings are applied. To view Sample Tube Settings, see the System
Configuration/Phadia 250 Parameter Setting/Tube Settings section.
Note: It is important to pop air bubbles and remove any fibrin clots from the sample tubes.
Remaining foam or air bubbles might be aspirated instead of sample.
Note: Changes in Tube Settings should only be performed by a Phadia Laboratory Systems
representative.
1. Check if there are air bubbles or fibrin clots in the sample tubes. Pop any air bubbles and
remove any fibrin clots using a disposable pipette tip to avoid contamination.
2. Load the sample tubes in the Sample Racks with Barcode labels vertically on the tubes.
3. Load the Sample rack with a smooth continuous move (put it on the 'rail', make sure that the
Barcode beam is activated and move it inwards in a continuous move, try to keep the same
speed and in parallel with load area) in the Sample Loading Area.
4. The Load Rack Information screen appears.
Check that the content is OK.

Press CONFIRM to confirm Rack Id and Sample Id Reading.
5. To enter a sample Id manually, press the field to display the keyboard screen, and you will
then return to the Sample Rack Information screen.
6. Repeat the steps above for all Sample Racks. It is possible to load 5 Sample Racks at a time.
Note: When a sample is finished, e.g. all tests for that sample is pipetted, then the sample is
completed and can be removed from the instrument. A new rack with samples can be inserted
into the instrument at any time during the process (continuous sample load).
End Assay
1. On the Assay Processing screen (in the ISW), press END ASSAY to open the Assay
Processing Pause/Continue screen.
2. On the Assay Processing Pause/Continue screen, select how the Assay Run should be ended.
Several options are available.
End assay choice

Option Function
End after all loaded samples are processed All samples in the loaded racks will be
processed before termination. Default.
End after dispensed ImmunoCAP/EliA Well Only the tests that have already started will
are processed be processed before termination.
The instrument will stop immediately. No
Abort
more result will be delivered. This requires a
service password. Emptying of the reaction
wheels and weekly maintenance must be
performed after abortion.
Note: All processing reagents and samples will be lost at abortion! A Super User must initialize
ejection of ImmunoCAP and Elia well from the reaction wheel. This Super User Maintenance
is described in the Maintenance chapter. Also, weekly maintenance is required according to
the instructions in the Maintenance chapter.
Rinse option
Daily rinse
Primed (Standby)
3. Select End after all samples are processed and Daily rinse (recommended).
4. Press OK to confirm the selection.
5. The Assay Processing Status screen displays that the assay is ended and by which selection.
The name of the END ASSAY button will change to CANCEL TERMINATION.
The instrument will process all loaded samples and then automatically start the End Assay
Procedure.
The time until rinsing is finished is displayed.

When the rinse procedure is completed, the System Power will be switched off automatically
and the instrument will enter stand-by mode.
Note: It is possible to load new samples until 5 minutes before the rinsing starts.
Note: If the time since the last ImmunoCAP/EliA Well in the reaction wheels was ejected exceeds
the default value 180 minutes, and no rinse has been performed, a rinse is automatically started.
A warning message is displayed: Assay run was finished automatically due to inactivity to secure
instrument function.
Results are sent to IDM, where calculation and Result Management takes place.
Note: Automatic unloading of empty and low frequency test is not available when the Carriers
on the Loading Tray are registered and the Loading Tray is locked. No Carrier can be transferred
to or from the Carrier Storage during this mode. The Carrier Loading Tray must be unlocked and
removed, and another empty tray loaded before performing unloading of Carrier, see
Unload/Empty.
Manage Results
When the tests have been run in the instrument, results are evaluated, approved, printed and/or
exported to/from the IDM.
In this example, results are automatically approved and exported to the LIS.
If the feature for automatic approval of results is not activated, more information can be found
in the Result Management section, or in the Result - F3 chapter of IDM User Manual.
Use the Result window in IDM to view Calibrator results, Curve Control results, Quality Control
results or sample results. To get there, click the RESULT - F3 button in the IDM Workplace.
Results for a selected Analytical Run (date and run) can be viewed.
View the results using the different tabs. For example, use the Samples tab to review, reject or
approve sample results for the selected Analytical Run. All results with errors or measurements
outside the measuring range must be manually approved or rejected before the Analytical Run
is approved.
Use the Assays tab to view result information for all tests in a selected Analytical Run, such as
time of measurement, response value or concentration.
For example, use the Approval tab to view approval status for Analytical Run. Use the different
buttons to approve, delete, reject or recalculate the selected Analytical Run.
Information Group Box View method, instrument (Instrument ID that the run was
performed on) and Calibrator (If the run was a calibrator run).
Status Group Box View status of the run and if it is approved or not (operator that
approved it).
Process Time Group Box Time for start and end of run.
Approve button Approve the run.
Delete button Delete the run.
Reject button Reject the run.
Recalculate run button Recalculate the run after changing parameters (Only available
if no result been approved)
Save button Save changes to the run
If you have failed calibrators or curve controls, see the Acceptance Rules section.
Request Management
Depending on the setup you may handle Request registration in different ways. This chapter
describes how requests can be imported using the IMPORT button or added manually using the
NEW button in the same screen. Also, conditional reflex tests can be added if a prior test fulfills
certain criteria.
All requests are handled in the Request List window.
For information about fully automatic synchronization of requests between the connected
mainframe and IDM, contact your local Phadia representative.
For more information see IDM Reference Guide/Request F2 e.g. Sample filter options.
Sample Tube Type

To obtain correct results, the tube type for each sample must be selected. During installation, a
service personnel will set up the tube type specifications. Before starting a run, the operator shall
make sure that the correct tube type is selected for each test.
The available Sample Tube Types are:
Normal
Pediatric
Type 3 (customer defined)
Type 4 (customer defined)
Reserved
The tube type can be selected in the following manners:
1. In the Request List, during manual request entry.
2. In the Request List, after automatic request import.
3. In the Racks List, for all samples in one Rack, if all these samples have identical tube type.
For more information, see the dedicated sections in the chapters Request Management and Sample
Management .
Import Requests
It is possible to import requests into Phadia IDM from a connected mainframe using IMPORT
command before starting an assay.
To import requests using IMPORT command:
1. In the IDM Workplace, click the REQUEST - F2 button.
Result: The Request List window will open.
2. In the Request List window, click the IMPORT button.
Result:
When the ASTM format is used, you will be notified that an import request is sent to the
mainframe. The import is performed automatically.
When the Phamas or the MasterCAP format is used, the Mainframe Import window
opens.
3. In the Mainframe Import window, click the RECEIVE button. An import file containing all
new requests will be added to the import files list.
4. Select the import file from the list and click the IMPORT button. The new requests will be
imported into the IDM.
Note: Requests with specified dilution factors will only be imported if the instrument dilution
factor is validated and released. For more information about approved dilution factors, contact
your local Phadia representative.
Enter Request Manually
The IDM allows you to create a new request manually. This is useful if the IDM is not connected
to a Mainframe server.
1. In the IDM Workplace, click the REQUEST button.
Result: The Request List window opens.
2. Click the New button.
Result: The Request window opens.
3. Enter Sample ID using the keyboard or the barcode reader.

4. Select Tube type in the drop-down list.
5. Click the Add Test button.
Result: The Add Tests to Request window opens.
6. Select method in the left-hand field.

Result: The tests that are available for the selected method are listed in the right-hand field.
7. Select test and click Add.
Result: the Add Tests to Request window is closed and the test is added to the Request
window.
8. Add all remaining desired tests.
9. Click Save.
Result: The Sample and the selected tests have been saved as a request, now available in the
Request window.
Enter Request using a Barcode Reader (IDM)

You can use a barcode reader, or use the ALT + F12 feature, to enter the barcode for a sample
not stored in the IDM database if IDM is connected to a mainframe.
IDM will then contact the mainframe and poll for a request, providing that this feature is activated.
To activate the feature, select the Ask for missing requests checkbox under the Mainframe tab
of the Preferences feature in the IDM software.
If you enter the barcode for a sample included in the IDM database, the Request screen for that
sample will open. If you enter the sample barcode again, or click the MAINFRAME REFRESH
button, IDM will contact the mainframe and check for updated request information, providing
that this feature is activated. To activate the feature, select the Refresh existing requests checkbox
under the Mainframe tab of the Preferences feature.
To enter a request by using a barcode reader or by using the ALT+F12 feature.
In the Request List screen, scan the barcode with a barcode reader or type in the barcode after
activating the ALT+F12 feature (press the ALT button and the F12 button on the PC keyboard
at the same time).
View Request
The registered requests can be viewed in the Request List window.
Samples are listed with ID, Status, Tube type etc. It is possible to filter the list by selecting one
of the right-hand radio buttons:
All
Not started
Processing
Ready
Approved
Rejected
Reported
Error
Reflex
Additional filters in the Sample Filter Option window are reached by clicking the Open Filter
button in the Request List window. Only disabled test can be viewed, for example.
Instructions for reflex testing
Reflex testing is a way of easily creating new requests for samples that have been processed. By
using reflex testing you can automatically create one or more follow-up tests to be performed on
the same sample. Below follows a few examples for the use of reflex testing.
Example A: If running an allergen mix on a sample and the result of the mix is positive, you can
have the system set up so that the specific tests of that mix will be added automatically to the
sample.
Example B: If running a specific allergen and it is positive, you can have the system set up so
that the different components of that allergen can be added to the request.
Example C: If running a test and the concentration is above the measuring range you can set up
the system to create a request for that sample with a dilution. (EliA only).
You can use the different criteria to set up reflex conditions. Reflex conditions can also be
correlated to specific requestors. The reflex tests will be created first after the prior test which
the criteria is based on is approved. When the reflex requests have been created just reload the
samples in the Rack Input Module.
A Superuser or Service can create a new reflex. To set up criteria and tests follow these
instructions:
1. Click System (F8) in the IDM start menu. The System window appears.
2. Select the Reflex Tests tab.
3. Select Reflex (circled in red).
4. Click New. A pop-up window appears.
5. Enter Reflex name.
6. Enter Requestor if you want to limit the usage of this reflex to requests coming from a specific
requestor.
7. To automatically generate the reflex test select Automatic.
8. Check the Active checkbox to activate the reflex testing.
9. Click New. A pop-up window appears.
Enter Reflex name.
Enter Method.
Enter Test name.
Enter Result type.
Enter Compare type.
Enter Compare value 1.
Enter Compare value 2 (only when between has been selected in the compare type field).
10. Click Save (window 1 closes).

11. Click Save (window 2 closes).
12. Select the test in the list.
13. Click Add. A pop-up window appears.
14. Select method/s in the list.
15. Select test/s in the list. These are the tests to be generated if the reflex is triggered.
16. Click Add.
17. Click Close.
18. Click Back.
Disable/Exclude test
Tests can be excluded from the present assay run and included in a later run. This can be useful
if there is a momentary lack of certain reagents, for example. Follow the instruction below to
disable a test.
1. In the IDM Workplace, click the Request button.
Result: The Request List window opens.
2. Select the desired request with Status Not started that contains a test to disable from the list
and click Open.
Result: The Request window opens.
3. In the Request window, click the Disable Test button.
Result: The Disable Test window opens.
4. Select a test and click Disable.

Result: The selected result will not be included in an assay run until it is set to enabled in the
Disable Test window.
Note: To view only disabled tests, select Test, Disabled test and Yes in the Sample Filter Options
window, see View RequestThe registered requests can be viewed in the Request List window. .
Export Requests Manually

You can export requests from Phadia IDM to a connected mainframe/LIS.
To export requests manually:
2. In the Request List window, click the EXPORT button.
Result: The Mainframe window will open.
3. In the Mainframe window , select whether to include tests without results in the export file
or not by clicking the YES or the NO button.
Result: The Mainframe Export window will open.
4. In the Mainframe Export window , select the wanted export file from the list and click the
SEND button.
Reset Request Status

You can change the status for selected requests to Not Started.
To reset the status for one or more requests:
2. In the Request List window, select the wanted request(s) from the list and click the RESET
button.
Sample Management
Before you can start performing an assay, the IDM needs request data.
You can let the IDM receive request (link) data from the mainframe automatically, or you can
import requests before starting an assay. You also have the option to enter requests manually.
This is described in Request Management.
Sample Racks may be loaded and unloaded during processing.
Note: Only the tubes types that are defined in the instrument should be used. Ensure that the
tube parameters are properly defined for used sample tube types.
Note: In order to ensure proper sample volume pipetted, it is always important to visually check
the samples before loading them into the instruments e.g. check that the volume is enough for
requested tests, including necessary dead volume.
About Sample management

Sample management includes the following phases:
Phase Description
1 Enter/import requests, see Request Management.
2 Define Sample Rack.
3 If only one Tube Type is used in a Sample Rack, configure this Rack.
4 Load Sample Tubes in Sample Rack.
5 Load Sample Rack in instrument.
Always use the barcode for correct registration during loading. If it is not possible to read barcodes,
use predefined racks and manual registration of Sample tubes until the barcode reading problem
is solved.
Sample Racks may be loaded and unloaded during processing.
In the following sections, the different procedures in sample management are described.
You can also prepare a dedicated Quality Control Rack, see the Quality Control Management
chapter.
Define Sample Rack

Follow the instruction below to define a rack as Sample Rack. Once you have defined the necessary
number of racks you can use them when they are empty. Sample Racks may be loaded and
unloaded during processing.
1. Take a new Sample Rack.
2. Fasten a new Barcode Label on the rightmost front area.
3. In the IDM Workplace, click the RACK - F5 button.
4. In the Rack List window, click the NEW button.
Result: The New Rack window will open.
5. Enter the Sample Rack Id (see the Barcode Label) in the Rack Id field.
6. Select Sample from the Type of Rack list.
7. Click OK.
Result: The new Sample Rack is added to the Rack List.
Configure Sample Rack

A Sample Rack can be configured to hold one specific tube type. When the Sample Rack is
loaded, the Phadia system will read the Rack ID, identify the configuration and treat all samples
according to the selected tube type. When using a configured Sample Rack, the individual samples
do not need tube type selections in the Request List.
1. Select the desired Rack in the Rack List and click Configure in the right-hand menu.
Result: The Configure Rack window opens.
2. Select tube type (Pediatric, Type 3, Type 4, Reserved) in the drop-list and click OK. It is also
possible to select Normal setup, to use the request settings specified in the Request List.
Result: In the Rack List, normal Racks are displayed with green Rack ID icon and Type
Sample, while configured Racks are displayed with yellow Rack ID icon and configured Type.
The Rack configuration will be displayed in the title of the individual Rack window and displayed
as Rack type in the printed Rack Contents document.
Sample and Rack Handling
This section describes how to handle the Sample Tubes and Sample Racks in a safe and correct
manner. The full instruction for loading samples including the software commands is provided
in the next section.
Loading sample tubes into racks
Before loading sample tubes into racks ensure that all racks are OK and that they are not broken.
Check that all tube holders that center the tubes are OK. A broken rack shall never be used on
the instrument; this can cause incorrect pipetting from sample tube.
1. Load the tubes into sample racks with the sample barcode facing the opening for the barcode
reader (BCR).
2. Turn the tube gently to get correct position.
3. Ensure that there are white zones on both sides of the code.
4. Check that all tubes stands straight in the rack and at the bottom of the rack to ensure correct
pipetting from the tube.
Loading a Rack into the Instrument
A sample rack can be loaded in any free rack position. Handle one rack at the time in the sample
loading area to avoid activating sensors and confusing the instrument.
1. Hold the rack by the handle and place it at the front of the sample loading area.
2. Let the weight of the front of the rack be supported by the instrument and feel that the rack
does not lean to the left or the right.
3. Ensure that the barcode beam is on before pushing the rack in.
4. Push the rack forward the whole way in until it is locked. Do not pull it back.
5. Check that barcode reading was OK on the confirmation screen and then press CONFIRM.
If barcode reading was not OK, press RELOAD.
1. The rack must be tilted when it is first

inserted into the instrument. The rack
must touch the barcode reader startup
line.
2. Let the wieght of the rack be supported
by the instrument surface during
insertion.
3. The rack stops when it reaches the
rails. At this position lower the tack
handle and push the rack in.
Note: When the rack is inside the sample loading area during process. It is strictly forbidden
to lift, or remove, tubes from the rack. Tubes shall only be handled outside the instrument, i.e.
when the rack is not loaded into the instrument.
Unloading a Rack
When the rack is processed it is unlocked from loading area. The indication light below the rack
turns green.
Unload the rack by pulling it out. When unloading, take the rack completely out of sample loading
area before handling next rack. Handle one rack at the time in sample loading area.
Load Sample Tubes

First, Sample tubes are loaded into sample racks. Then, the Sample Racks are loaded on the
Phadia instrument.
is solved.
Note: It is important to always load samples with sufficient volume for all tests to be run including
dead-volume (dead-volume differs from different tubes).
Note: It is important that the correct sample tubes type is selected and that the settings for the
tube type are correct. To view the tube type, see the Request list, described in Request
Management. For information about the Sample Tube Settings, see the Tube Settings section in
the System Configuration chapter.
Note: The tube settings are not applicable for primary tubes, as there is gel instead of sample in
the bottom of the tube. Make sure that there is sufficient sample volume above the gel for all
tests to be run including dead-volume, in order to avoid that the pipette aspirates gel.
Load Sample Tubes with valid Barcode in Rack

This is the standard procedure for loading Sample Tubes in Sample Racks.
Note: Sample tubes must be placed in an upright position at the bottom of the Sample Racks.
Any misalignment of the sample tube might cause the sample not to be properly aspirated.
3. Select the Not started option from the Status Options List.
4. Make sure that the Sample Tubes are listed in the Request List.
5. Make sure that the correct Tube type is selected in IDM.
7. Load the Sample Tubes into an empty Sample Rack. The Sample Tubes may be loaded
randomly if the Barcode on the tubes is used.
8. Make sure that the Barcode is in the correct reading position.
Result: The Sample Racks are now ready to be loaded into the instrument.
Note: A Sample ID can only be present in one position at the same time on an Phadia system,
which also includes clustered instruments.
Load Sample Tubes with invalid Barcode in Racks

use predefined racks and manual registration of Sample tubes as described below until the barcode
reading problem is solved. This instruction is also applicable if the Barcode is missing on a
Sample Tube.
If there are a few Sample Tubes with invalid Barcode, follow the instruction below. However,
if there are many Sample Tubes with invalid Barcode, it is possible to allocate them all at once
to a Sample Rack, see Allocate Sample to Rack .
Note: Sample tubes must be placed in an upright position at the bottom of the Sample Racks.
Any misalignment of the sample tube might cause the sample not to be properly aspirated.
3. Select the Not started option from the Status Options List.
4. All requests with status Not started are listed.
5. Make sure that all Sample Tubes with invalid Barcode have been registered. If not, see Enter
Request Manually .
6. Click the Print button to print the list.
7. Click the RACK - F5 button.
8. In the Rack List window, select a Sample Rack with 0 in the Used Rack Positions column.
9. If you do not have any accessible Sample Racks, define a new Sample Rack or unload and
clear a used one.
10. Click the OPEN button.
The Sample Rack Id window will open.
11. Enter the Sample Id for the first empty position according to the printed Request List.
12. If the tube is defined as Pediatric, select the appropriate checkbox in the Pediatric column.
13. Select the Skip barcode reading checkbox.
15. Place the Sample Tube in the corresponding position in the Sample Rack.
16. Repeat steps 10 to 14 for the rest of the tubes.
17. When the last tube is placed, or when the rack is full, click BACK to return to Rack List
window.
Allocate Sample to Rack

Sample Tubes can be allocated to a Sample Rack. This is useful when managing many Sample
Tubes with invalid barcodes. Instead of manually entering data for each Sample in a Rack, the
data in the Request List is copied to the selected Sample Rack.
Note: The operator must load the Sample Tubes in the Sample Rack in the exact same positions
as registered in order to obtain correct results. For more information about loading Sample Tubes
and Sample Racks, see Load Sample Tubes.
1. Open the Request List.
2. Click Menu to activate the sub-menu.

Result: The sub-menu opens.
3. Select the first Sample with invalid barcode.
Press down the ctrl key while selecting all remaining Samples with invalid barcode of interest.
4. Click the Allocate to Rack button.
Result: the Allocate to Rack window opens.
5. Select a Rack in the right-hand field. Make sure that the Sample Rack configuration (Type)
suits the Sample Tube Type of the selected samples.
6. Click OK.
Result: The selected Samples are registered in the selected Sample Rack.
Load a Sample Rack on the Instrument

1. Load the Sample Rack(s) containing sample tubes into the instrument. It is possible to load
up to 5 Sample Racks at a time.
Note: Load the Sample rack with a smooth continous move in the Sample Loading Area.
2. The Load Rack Information screen appears.
3. Check that content is OK. If it is, go to step 5. Otherwise, continue with the next step.
4. Red fields are unreadable Sample Barcodes on the loaded sample racks, while grey fields are
empty positions:
If a few fields are red, press a field to display a keyboard and manually enter Sample Id.
Repeat for all red fields.
If the first sample barcode is unreadable then the Rack Id will also be red (the instrument
is not certain that the Rack Id is correct). In this case it is recommended to press RELOAD
button to reload the Rack and return to step 1.
5. Press CONFIRM to confirm Rack Id and Sample Id reading, and you will return to the Sample
Rack Information screen.
Reagent Management
This section reviews how to manage all the reagents needed for assay.
Printing of load list, on-board stability, preparation of Washing Solution and how to load and
unload the different reagents needed are described here.
use manual registration of reagents until the barcode reading problem is solved.
Note: Make sure to enter correct barcode if it is registered manually. This is especially important
for Carriers, as an incorrectly entered barcode might be identical to another Carrier's barcode,
which may lead to misleading and incorrect results.
Print Loadlist
Before loading the instrument, a load list should be printed. The load list specifies the amount
of items that need to be loaded.
1. In the IDM Workplace, click the icon representing the wanted instrument.
The Instrument Information window will open.
2. In the Instrument Information window, select the Loadlist tab.
3. Under the Loadlist tab click the PRINT button.
The Print Loadlist window will open.
4. Click the PRINT button.
5. The Loadlist will be printed.
Another way to review which reagents that needs to be loaded are to check consumables which
is described in Check Inventory.
On board Stability
Reagents are stable for a certain number of days after they are loaded into the instrument. This
is called on board stability. IDM sets an expiration date for the loaded reagent according to the
on board stability. The expiration date in IDM may differ from the expiration date on the label
of the reagent, as the label date is applicable for unused reagents placed in cooled storage. See
table below for details about on board stability.
Phadia EliA on Phadia

250 Phadia 250 1000
Calibrator/ CC-strip 28 days. If >3 days between usage, unload the strip and store
at 2-8 C.
Conjugate 4 days open at Single use reagent.1 7 days open at
2-8 C. Recap bottles 2-8 C.
every night.
Development solution 40h open at room temperature. Can be used 14 days open at
5 times during shelf-life and be stored at 2-8 C.
room temperature for 8h on each occasion.
Recap bottles every night.
Stop solution Until expiration date. Recap bottles every Until expiration
night. date.
Wash solution 7 days at room temperature. Discard every seventh day and
perform weekly maintenance according to respective instrument
(prepared solution)
user manual.
Sample Diluent 7 days at room temperature. Re-cap bottles N/A
every night.
ImmunoCAP/ EliA carrier Until expiration date. 28 days at 2-8 C or Until expiration
24h at room date.
temperature.
1
EliA IgA, EliA IgG and EliA IgM Conjugate 200 can be used the next calendar day if less than
50 samples have been run the first day and the bottle is recapped and stored at 2-8 C over night.
EliA IgA, EliA IgG and EliA IgM Conjugate 50 can be used the next calendar day if less than
10 samples have been run the first day and the bottle is recapped and stored at 2-8 C over night.
Note: The instrument will check the level detection at the start of assay and keeps track of
number of doses left.
Load Reagents
Reagents have to be loaded before start of an assay. It is recommended to lift the protection hood
during loading.
use manual registration of reagents until the barcode reading problem is solved.
Note: Make sure to enter correct barcode if it is registered manually. This is especially important
for Carriers, as an incorrectly entered barcode might be identical to another Carrier's barcode,
which may lead to misleading and incorrect results.
According to the Loadlist the following reagents need to be loaded:
Diluent
Dilution Plate
Stop Solution
Conjugate
Calibrator/CC
ImmunoCAP / EliA well Carrier
In addition, load the following:
Wash Solution
Rinse Solution
Note: Wash Volume Check starts automatically at assay start, if the corresponding system
parameter is set to ON.
20 Xummy wells are needed. It is not sufficient to place them in the Carrier loading tray.
Load Conjugate
Note: EliA Conjugate is for single use only. For each run a fresh unused bottle has to be loaded.
1. Take out the Conjugate from the refrigerator.
2. Go to Start Menu screen on the instrument by pressing BACK until you get there.
3. On the Start Menu screen, press LOAD.
4. On the Load screen, select Conjugate Tray.
5. If necessary, unload a conjugate bottle according to Unload Conjugate.
6. On the Conjugate Information screen, select a position by pressing an empty field.
8. Take the new Conjugate bottle according to the Load List.
9. Read the Barcode on the Conjugate bottle with the Manual Barcode Reader.
10. Remove the cap from the bottle to be loaded.
12. Load the Conjugate bottle in the flashing position.
13. Check in the Lot number column in the table in the Conjugate Information window if the
Conjugate bottles that will be used during the assay have different lot numbers.
14. If the Conjugate bottles have different lot numbers, load an additional Calibrator Strip.
Note: Do not unload and reload bottles that have been used if not necessary, see On board
Stability.
Load CC/Calibrators
Note: Add an additional CC and/or Calibrator strip for each method performed, in order to enable
additional calibrations during the assay.
Note: Always make sure to mix strips before assay. Before loading a Calibrator/Curve Control
strip:
1. Carefully shake the strip side by side.
2. Force all liquid to the bottom of the strip by gently knocking it onto a table.
3. Make sure no foam or air bubbles are in the strip after shaking it.
4. Check that no bubbles are captured in the bottom.
Follow the instruction below to load Calibrators or Curve Controls.
1. Take out the Strip (Calibrator and/or Curve Control (CC)) from the refrigerator.
2. Go to the Start Menu screen on the Instrument by pressing BACK repeatedly.
4. On the Load screen, select Strip Tray.
5. On the Strip Information screen, select a position by pressing an empty field.
6. Take the new Calibrator/CC Strip according to the Load List.

8. Read the barcode on the new Calibrator/CC Strip with the Manual Barcode Reader.
9. Load the Calibrator/CC Strip in the flashing position into the Strip Tray.
10. Repeat steps 5 to 9 to add more strips.
11. If the Calibrator/CC strip is full, press BACK to return to the Load screen. If not, continue
with the next step.
12. Select the position of the previously used strip.
13. Press the arrow button to display the Delete Wellbutton.
14. Press the Delete Wellbutton once for each well to be deleted.
Result: The well/wells turns red and the Status of the strip changes to In use.
For more information, see the Reagent Handling section of the System Description chapter.
Preparation of Washing Solution

Note: Diluted Washing Solution may cause sensitization by skin contact. Wear suitable gloves.
Please be aware that inadequate mixing of the Washing Solution may lead to false results.
Therefore always mix Washing Solution properly according to the following instructions:
1. For mixing the Washing Solution use an extra container. Do not use the bottle of the Phadia
instrument.
2. Always start filling the container with Rinse Solution and then add Washing Solution Additive
and Washing Solution Concentrate.
3. Put the cap on the extra container and mix it by inversion or, alternatively, mix the Washing
Solution with help of a magnetic stirrer.
4. Disconnect and empty the Washing Solution bottle.
5. Wash the Washing Solution bottle.
6. Transfer the mixed Washing Solution into the instrument's Washing Solution Bottle.
Load Washing Solution

1. Go to the Start Menu screen on the instrument by pressing BACK until you get there.
3. On the Load screen, select Waste/Wash/Rinse Bottles.
4. On the Waste/Wash/Rinse screen, select Wash Solution.
5. Prepare Washing Solution according to Preparation of Washing Solution .
7. Read the barcode on the outer label on the Washing Solution Kit with the Manual Barcode
Reader.
Result: The barcode is displayed.
8. Load the filled Wash Solution bottle into the shelf.
9. Connect the tubing.
10. Push the shelf with the bottles inwards.
Load Rinse Solution

1. Disconnect and remove the empty bottle.
2. Use purified water as Rinse Solution.
3. Load the filled Rinse Solution bottle into the shelf.
5. Push the shelf with the bottles inwards.
Load Stop Solution/Development Solution

1. Go to the Start Menu screen on the Instrument by pressing BACK until you get there.
3. On the Load screen, select Development/Stop Solution.
4. Take out Stop Solution/Development Solution from the refrigerator.
5. Uncap (ongoing/new) bottles.
7. Read the Barcode on the (ongoing/new) Stop Solution bottle with the Manual Barcode Reader.
8. Uncap the bottle.
10. Load that bottle in position 1 (the flashing position).
11. Read the Barcode on the (ongoing/new) Development Solution bottle with the Manual Barcode
Reader.
12. Uncap the bottle.
14. Load that bottle in position 1 (the flashing position).
15. Press BACK to return to theLoad screen.
16. To load more bottles, repeat the steps above but load in position 2, 3, etc.
Note: If the material is expired, an error message will be displayed. Close the EXPIRATION
SETUP window to return to the Load screen and unload the expired reagent. For more information
about expired reagents, see the Accept Expiration Date section.
Stability.
Load Diluent
3. On the Load screen, select Dilution Tray.
4. Uncap bottles.
6. Read barcode on the Diluent bottles with the Manual Barcode Reader.
7. Load the bottles in the flashing position on the Diluent Information screen.
Stability.
Load Dilution Plate

1. Go to the Start Menu screen on the instrument by pressing BACK till you get there.
4. On the Diluent Information screen, press DILUTION WELL (if this key is not visible, use
the TOGGLE key to change key functions.
5. Load the dilution plates in the Dilution plate tray. Optical sensors will detect if a plate is
present and the information lists on the Dilution Well Information screen will be updated.
6. Press BACK to return to the Diluent Informaiton screen.
Carrier Loading Alternatives

Carriers are always loaded on the Loading Tray. However, there are two alternatives for reading
the barcode and three alternatives for storing the Carriers before use in the assay run.
Reading the barcode
The alternatives are described in the sections referenced in the table below:
Alternative Management For more information see..
Use automatic reading during Routine procedure. LoadCarrierandTransferintoStorage
Transfer to Storage or Scan or Registered Loading Trays
Tray.
Use Manual Barcode Reader. Useful for non-full Carriers that UseManualBarcodeReaderandEditDosesinCarrier
need manual edit of number of
doses.
Storing the Carriers

The alternatives are described in the sections referenced in the table below:
Alternative Management For more information see...
Transfer Carriers to Carrier Routine procedure. LoadCarrierandTransferintoStorage

Storage.
Carriers remain in Loading Carrier Storage is not used for Registered Loading Trays , but
Tray during an assay. the loaded Carriers. press Clear Tray after an assay
to unregister (delete all
information about) all Carriers
on the tray.
Register the content of several Carrier Storage is not used for Registered Loading Trays
Loading Trays. Carriers remain the loaded Carriers. The system
in Loading Tray until empty. keeps track of Carriers in
unloaded trays that are stored
in the refrigerator.
Note: When the Loading Tray, instead of the Carrier Storage, is used as storage during an assay,
the Carriers will automatically be registered. It is possible to keep the registration by simply
unlocking the tray, or to delete all Carrier information by clearing the tray. If several Loading
Trays are available, and the same Carrier set-up will be used soon, the recommendation is to
keep the registration.
Load Carrier and Transfer into Storage

Note: All relevant ImmunoCAP and/or EliA wells must be loaded before the assay starts in
order to perform QC tests.
Note: To be able to use Carriers directly from Loading Tray during assay, without transferring
them to the Carrier Storage, see Registered Loading Trays .
20 Xummy wells are needed. It is not sufficient to place them in the Carrier Loading Tray. Wash
Volume Check starts automatically at assay start, if the corresponding system parameter is set
to ON.
In this instruction, Carriers are loaded on the Loading Tray, the tray is loaded on the instrument
and the internal barcode reader reads each barcode before the Carrier is transferred to Storage.
This is the routine procedure. However, it is also possible to use the manual Barcode Reader
before loading the Carrier on the Loading Tray. This is mostly used for Carriers with less that
full quantity of tests. Therefore, the procedure with the Manual Barcode Reader is described in
Use Manual Barcode Reader and Edit Doses in Carrier .
1. Go to the Start Menu screen on the instrument by pressing BACK repeatedly.
3. On the Load screen, select Carrier Loading Tray.
Result: The Carrier Loading Tray screen opens.
4. Press UNLOCK to unlock the Carrier Tray, if it is locked.
5. Remove the tray, if it is loaded on the instrument.
6. Collect ImmunoCAP/EliA well Carrier according to the Load List.
Note: EliA wells are sensitive against humidity. The on-board stability of each carrier will
be set to a limited time range after loading. The relevant expiry date is automatically displayed
by the Phadia instrument.
7. Load Carriers in the Carrier Loading Tray. Start with position 1 (left row, rearmost position),
fill row by row from left to right. Do not leave any empty positions.
Note: If any Carriers contain less than full quantity of tests, do not load them yet. Transfer
the full Carriers to Storage first.
8. Push the Carrier Loading Tray onto the instrument.
9. Press START TRANSFER TO STORAGE.
Result: The instrument reads the barcodes and places the Carriers in the Carrier Storage.
Note: Carrier information that was corrected above is not overwritten. The system will only
verify that these Carriers are correctly positioned in the tray.
10. If any Carriers contain less than full quantity of tests, load and correct the number of
ImmunoCAP / EliA wells for a carrier according to Use Manual Barcode Reader and Edit
Doses in Carrier .
Use Manual Barcode Reader and Edit Doses in Carrier

Most often, the internal Barcode Reader is sufficient for scanning or transferring Carriers to the
Carrier Storage. However, there are two situations when the Manual Barcode Reader is used.
To load Carriers with less than full quantity of tests.
To load Carriers during an assay run.
Note: If the Loading Tray is registered and the Carrier has remained on the tray since it was
used and until the tray was again pushed onto the instrument, the system will keep track of data
about the Carrier and no Manual Barcode Reader or Edit is required.
If a Carrier has been used previously, been unloaded and is again loaded on the Carrier Loading
Tray, the system will not automatically identify the number of ImmunoCAP/EliA wells that
remain in the Carrier. If any Carriers contain less than full quantity of tests, these must be read
using the Manual Barcode Reader and placed in the position in the Loading Tray corresponding
to the flashing position in the instrument software illustration. Use the Manual Barcode Reader
and edit the quantity by following the instruction below.
1. Make sure that all full Carriers already have been transferred to Storage, if applicable.
2. Press UNLOCK to unlock the Carrier Tray, if it is locked.
3. Remove the tray, if it is loaded on the instrument.
5. Read the barcode of the Carrier that requires correction.
Result: If the barcode is recognized, the first empty position in the illustration on the left hand
of the Carrier Loading Tray screen flashes with green color. Information about the Carrier
is displayed in the table.
6. Select the Carrier in the table.
7. Press EDIT DOSES and enter the correct number of ImmunoCAP / EliA wells in the Carrier.
8. Place the Carrier in the corresponding empty position on the tray.

9. Repeat for all Carriers that contain less than full quantity of tests.
10. The Carriers can be stored on the Loading Tray or in the Carrier Storage for usage during
assay.
If Carriers shall remain on Loading Tray: Continue with loading the full Carriers, pushing
the Carrier Tray onto the instrument and scan the tray. See the corresponding instructions.
If Carriers shall be transferred to Storage: Continue with pushing the Carrier Tray onto the
instrument and transfer the Carriers to Storage. See the corresponding instructions.
Note: If the Manual Barcode Reader is used and Scan Load Tray is selected, scanning will be
performed on the positions after the manually read Carriers. However, if the Manual Barcode
Reader is used and Transfer to Storage is selected, transfer will be performed on the manually
read Carriers. If any Carrier is entered manually before transfer to storage, the instrument will
assume that all Carriers are entered manually. For transfer to storage, it is recommended to load
and transfer the full Carriers first, and then manually read and transfer the ones that need edit of
doses, as described in this instruction.
Unload/Empty
Unloading of most of the reagent containers are preferably done in connection with loading of
new. Unloading of Rinse/Wash Solution Bottles is described in the Load Reagents section.
Here you find descriptions of unloading of:
ImmunoCAP / Elia Well Carrier
Development Solution Bottles
Conjugate Vials
Stop Solution Bottles
CC/Calibrator strips
Diluent
Dilution Plate
and emptying of:
Used ImmunoCAP/EliA well Carrier
Unload Conjugate
4. On the Conjugate Information screen, select a position by pressing a field that contains an
empty bottle or a bottle that shall be unloaded, or select the checkbox in front of the bottle(s).
The UNLOAD key is activated.
5. Press UNLOAD.
6. Press OK to confirm the action.
7. Unload the selected bottle(s).
Action Keys
SELECT EMPTY key: Press to select empty bottles for unloading.
SELECT EXPIRED/ERROR key: Press to select expired bottles and/or bottles with error for
unloading.
UNLOAD key: Press to unload selected bottles.
Unload CC/Calibrators
4. On the Strip Information screen, select the strips you want to unload by pressing the fields
that contain empty strips, or strips that shall be unloaded, or select the checkbox next to the
strip(s). The UNLOAD key will be activated.
5. Press UNLOAD.
7. Unload selected strips from the tray.
Action Keys
SELECT EMPTY key: Press to select empty strips for unloading.
SELECT EXPIRED/ERROR key: Press to select expired/error bottles for unloading.
UNLOAD key: Press to unload empty strips
TOGGLE key: Press to display options to mark wells as used, use expired etc.
Unload Stop Solution/Development Solution

4. On the Development/Stop Solution Information screen, press UNLOAD to unload all bottles.
Unloading of single bottles is not possible.
6. Unload existing bottles from the tray.
7. Cap ongoing bottles and place them in a refrigerator. Dispose of empty bottles.
Unload Diluent
4. On the Diluent Information screen, press UNLOAD to unload all bottles. Unloading of single
bottles is not possible.
6. Unload existing bottles from the tray.
7. Cap ongoing bottles and place them in a refrigerator. Dispose of empty bottles.
Unload Dilution Plate
To unload Dilution Plates you only need to remove the used plates and the instrument sensors
will recognize that there is no plate(s). If you load a Dilution Plate after unloading you will get
an error message where you have to confirm that the new plate is unused.
Note: The instrument will remember used wells in the dilution plate as long the sensors and the
instrument's system power is on. It is possible to unload dilution plate when system power is off
and reload again before system power is switched on and information of used wells is stored. If
system power is switched on before plate is loaded the instrument will tell you to load new unused
plate.
Unload Carrier from Storage Tray

Note: If the presently loaded Carrier Loading Tray is registered, no Carrier can be transferred
to or from the Storage Tray.
If the Carrier Loading Tray is registered, first unlock and unload the tray according to the first
instruction, and then unload the Carriers from Storage Tray according to the second instruction.
If the Carrier Loading Tray is empty and non-registered, unload the Carriers from Storage
Tray according to the second instruction.
For registered Carrier Loading Trays, start with unlocking the tray:
3. On the Load screen, select ImmunoCAP/EliA Well Carrier Loading Tray.
4. On the Carrier Loading Tray screen, press UNLOCK.
Result: The tray is unlocked, but the registration of the Carriers remain.
5. Remove the Carrier Loading Tray and store it in the refrigerator.
Unload the Carriers from Storage Tray:
3. On the Load screen, select ImmunoCAP/EliA Well Carrier Storage.
4. On the Carrier Information screen, find Carrier to unload using the PREVIOUS and NEXT
keys, and the UP and DOWN keys.
5. Press the checkbox to the left of a Carrier to select it.
6. Press SELECT EMPTY ITEMS to automatically select all empty Carriers.
7. If desired, press SELECT LOW FREQUENT TEST, or the TOGGLE key and then
EXPIRED/ERROR to automatically select all Carriers that apply.
8. If the instrument is set to unload empty ImmunoCAP / EliA well Carrier to Carrier Loading
Tray: Load an empty Carrier Loading Tray.
9. Press UNLOCK.
Result: The Carriers are unloaded to the set destination and the information is removed from
list.
Emptying of Solid Waste Container

The Solid Waste Container is located underneath Phadia 250 on the shelf in the table.
Note: Use protective gloves.
Dispose of the waste according to local regulations.
Note: The waste might be infectious, handle it accordingly.
Emptying of Fluid Waste Container

The Fluid Waste Container is located underneath Phadia 250 on the shelf in the table. It is
connected to the instrument at the rear.
Note: Use protective gloves
1. Disconnect the tubing.
2. Dispose of the waste according to local regulations.
Note: The waste might be infectious, handle it accordingly.
3. Rinse the waste container with water.
4. Put the bottle back into its position.
Unload Sample Racks

It is possible to unload the Sample Rack when it has been processed and the LED has turned to
green.
Quality Control Management

The processing of Quality Controls is very important. With Quality Controls (QC) it is possible
to see long term variations and/or trends that cannot be seen when running Curve Controls. This
section describes the handling of Quality Controls, from entering the information in IDM to
loading on the instrument.
Also a short description of how to handle Quality Club samples is included.
Entering QC data in IDM

Note: The following information is applicable for multi allergen/analyte QC articles to be used
with Phadia instruments.
Use Phadia QC limits from DfU or vial label and lot number.
1. In IDM Workplace, click F8 - SYSTEM. The System window will open.
2. Select the Methods tab. Then select the wanted method and click OPEN.
3. In the Method 'Method Name' window, select the QC tab.
4. Under the QC tab, select the desired Quality Control and click OPEN. The Quality Control
window will open.
Example: sIgE Pos, Test d1has been chosen
New Quality Control

1. In the Quality Control window, select the Acceptance range option button.
2. Enter lot min value and lot max value. The values are found in the DfU.
3. Click the SAVE button.
New Quality Control Lot No. to QC Rack

1. In IDM click the RACK - F5 button. The Rack List window will open.
2. Select a QC Rack from the list and click the OPEN button.
3. Click the yellow folder to the right of the QC that needs to be replaced.
4. In Quality Control Details window, click UNLOAD.
5. Click the MANUAL ENTRY button and scan, or enter, the seven digit barcode of the QC
vial.
6. Click OK.
7. The position to the left of the folder will be blinking. Open the yellow folder again and click
OK.
The new vial lot no. will be added to the Rack.
After Establishing your own Mean Value for the Control

1. In the Quality Control window, select the Laboratory specific target value option button.
2. Enter the expected mean value.
3. Calculate SD and enter the value in the Default lot expected SD field.
4. Enter 3 as Default lot SD limits.
When entering established SD (after 1 year)

Enter the SD value. This value is found under the Quality Controls tab of the Quality feature:
1. In the IDM Workplace, click the F4 - QUALITY button.
2. Under the Quality Controls tab, select a QC using the drop-down list boxes in the Quality
Control Selection group box and click the STATISTICS button.
3. The SD value is found in the All data - SD field. Make sure that outliers are excluded. This
will include batch changes and changes in environmental conditions over time.
When a Lot Number for a QC is Changed

Introduce the new lot number.
1. In the Quality Control window (see above), click the NEW button. The Quality Control
Lot window will open.
2. Select the Acceptance range option button and enter the lot min value and lot max value. The
values are found in the DfU.
3. After 20 runs, open the QC and select the Laboratory specific target value option button.
4. Enter the expected value, mean value calculated for minimum 20 runs.
5. Use the obtained CV for the previous lot number(s) and calculate the Expected SD for the
new lot. Enter the calculated Expected SD.
6. Enter 3 as Default lot SD limit
Before loading and processing these Quality Controls you need to define QC Racks and load
them in dedicated Quality Control Racks that are loaded into the instrument.
Define QC Rack
This section describes how set a sample rack as a QC Rack and how to configure a new or select
an existing QC profile.
Create QC Rack
1. Take a new Sample Rack and fasten a new barcode Label on the rightmost front area.
2. In the IDM Workplace, click the RACK F5 button.
3. In the Rack List window, click the NEW button.
The New Rackwindow will open.
4. Enter the Sample Rack Id and select QC from the Type of Rack list. Then click OK.
5. The new QC Rack is added to the Rack List. When adding a new Rack, click UPDATE
INSTRUMENTS.
Configure QC Profile
1. In the IDM Workplace, click RACK F5.
2. Click the CONFIGURE PROFILES button.
3. In the Quality Control Profiles window, click the NEW button and enter the name of the
profile.
4. Click OK.
5. Select the new profile and click the ADD button.
6. In the Add Quality Control window, select the wanted method(s) and test(s).
7. Click the ADD button. Several methods may be added to a profile.
8. When done, click the CLOSE button.
Select QC Profile
To connect a QC Profile to a QC Rack, do the following:
1. In the IDM Workplace, click the RACK F5 button.
2. Select the wanted QC Rack and click the SELECT PROFILE button. The Select Quality
Control Profile window will open.
3. Select the wanted profile from the list and make sure that the Set as default profile for this
rack checkbox is selected.
4. Click the OK button.
Load Quality Control Vials
1. In the IDM Workplace, click the RACK - F5 button.
2. In the Rack List window, select a QC Rack with 0 in the Used Rack Position column and
with the wanted profile. If you do not have any accessible QC Racks, define a new one.
3. If no empty QC Rack with the wanted profile is available, you can either select a Quality
Control Profile for the rack, or configure a new profile.
4. Click OPEN.
5. The QC Rack Id window will open.
6. Read the barcode on the QC vial with the handheld barcode Reader, or click the MANUAL
ENTRY button in the QC Rack Id window.
7. Type the barcode and click OK.
8. Load the Quality Control vial in the position according to QC Rack Id window.
9. Repeat the procedure for all QC vials.
10. The rack is now ready to be loaded into the instrument.
Note: Sample tubes and Quality Control vials must be placed in an upright position in the Sample
Racks and Quality Control Racks.
Load QC Racks
1. Load the Quality Control Rack with QC vials in any position of the Sample Loading Area
(loading of QC rack is continuous).
Note: The loading of the QC rack is not possible before the Blank Measurement is completed.
2. The Sample Load Rack Information window will open.
3. Check that the content is OK.
4. Press CONFIRM, and you will come to Sample Rack Information
5. As soon as the QC Rack has been processed, remove the QC vials. Re-cap them and put them
in a refrigerator.
Note: EliA QCs are single use and have to be discarded after the run.
Quality Control Information in IDM

Quality Controls tab in IDM (Result - F3): View Quality Controls, one (specific limits) or
several (select several from the list, limits normalized max - min). If you select a QC-point from
the list it will be highlighted in the time chart, and vice versa.
Use the Quality (F4) window in IDM to view detailed information about the Quality Controls
for all methods. Here you also can deactivate, activate, comment and delete quality information
or print Quality Control Logs.
Manage Quality Club Samples in IDM

This section describes the procedure for managing ImmunoCAP/EliA Quality Club samples in
IDM and processing them on Phadia 250/1000 instruments.
To register a new Quality Club sample in IDM
1. In the IDM Workplace, click the QUALITY - F4 button.
2. In the Quality window, select the Quality Club tab.
3. To create a new Quality Club sample, click the NEW button.
The New Quality Club window will open.
4. Enter the Identity (year and month, yymm or yyyymm), Method, Sample lot number and Tests.
All information can be found in the DfU for the Quality Club Package.
5. Click OK.
6. A request is automatically created . The Sample ID includes the Identity and the Sample lot
number.
7. Click the REQUEST - F2 button.
8. Select the sample and click the OPEN button.
9. Select the Rack and Position for the Quality Club sample.
You do not need to change the Tube type. As the sample is defined as a Quality Club sample,
the instrument will know the type of tube to be used.
10. Click the SAVE button.

11. Click the RACK - F5 button.
12. Open the Rack you have selected for the Quality Club sample.
13. Select the Skip barcode reading checkbox.
Include ImmunoCAP/EliA Quality Club Samples in an Assay

Run
Now everything is prepared for processing the Quality Club sample. You run it as a normal
sample without a barcode. After the assay run is performed and the run is approved, you can
view the results and report them.
Proceed as follows:
1. When the sample has been processed and approved, click the QUALITY - F4 button. Then
select the Quality Club tab and view the results.
2. The results can be printed from the Quality Club tab. Select the sample and click the PRINT
button to print a report including the results and the reagents used.
3. When the Laboratory report is ready, make sure to properly fill in the Quality Club result card
with the results, or send/fax the laboratory report.
Result Management
After the process is completed, the results need to be approved. You can approve, or reject, the
result of a single test, or you can approve the run. Approved results can also be exported to the
mainframe. For more information see IDM User Manual/IDM Workplace/Result F3.
Approve Run
1. In the IDM Workplace, click the RESULT - F3 button.
The Result window will open.
2. In the Result window, select Date and Analytical Run from the Select Analytical Run
drop-down list.
The Calibrator tab will open.
3. Verify that the Calibration Curve is OK.
4. Select the Approval tab.
5. Under the Approval tab, click the APPROVE button. You will be prompted to confirm the
action.
The Calibrators tab displays the calibration curve for an assay run.
The lists displays more detailed information about each replicate.
The Calibrators used and Judgement fields display the calibrators and judgment used for
evaluation.
Click the CURVE DATA button to view statistics for calibration curves.
Click the EDIT CURVE button to edit the curve.
Click the SELECT CURVE button to select another curve for evaluation of the assay run.
Note: When an approved run is selected, the EDIT CURVE and SELECT CURVE buttons will
not be available. When the results for a sample included in a run are approved, you will not be
able to edit the calibration curve, or select another curve for evaluation.
Approve Results
2. In the Result window, select the Samples tab.
3. Under the Samples tab, select the wanted test from the Samples list and then click the
APPROVE button. You will be prompted to confirm the action.
The Samples tab displays sample results. In this window you can select sample results for
approval.
Click the APPROVE button to approve the selected sample results. The whole run can be
approved under the Approval tab.
Click the REJECT button to reject results. In the Reject Test window, you can determine how
to handle the rejected result.
Click the REQUEST button to open the request belonging to the selected sample.
Click the DETAILS button to display detailed information about the selected sample.
Reject Results
It is possible to reject a result from both the Request window and the Result window. The
instruction below refers to the Result window. In the Request window, the REJECT button is
placed in the Tests tab.
2. In the Result window, select the Samples tab.
3. Under the Samples tab, select the wanted test from the Samples list and then click the REJECT
button.
The Reject Test window will open.
4. In the Reject Test window, select the appropriate option from the Select Option group box
and click the OK button.
Export Results
After the results are approved, you may need to export them from Phadia IDM to the mainframe.
You can activate the automatic export feature, or you can choose to export the results manually.
Print Results
You can print a laboratory report for an analytical run. In the report you will find the results for
all tests included in the selected run.
For more information, see IDM User Manual, Result - F3 chapter.
Calibration and Acceptance
Calibration Curve
Calibration Curve Algorithms
Calibration Curves for ImmunoCAP Specific IgE, ImmunoCAP Total IgE, ImmunoCAP Specific
IgG, ImmunoCAP specific IgG4 and ImmunoCAP Specific IgA methods use 5-parameter logistic
functions, also known as Rodbard functions, as curve algorithms. ImmunoCAP ECP, ImmunoCAP
Tryptase, EliA IgG, EliA IgA, EliA IgM and EliA Calprotectinuse 4-parameter logistic functions,
also known as Rodbard functions, as curve algorithm. The used functions have a built-in
expectancy of the curve and will try to calculate the curve as close as possible to the expected
curve. The EliA IgG, EliA IgA, EliA IgM and EliA Calprotectin methods use the 4-parameter
Rodbard function from the second lowest calibrator to the highest calibrator. Between the zero
point and the second lowest calibrator a linear function is established. This function will be
created out of the first 4 calibrator points.
Acceptance of Calibration Curve
Establishment and acceptance of a calibration curve in Phadia Information Data Manager Software
includes examination of the obtained calibrator point signal values against predetermined expected
levels and limits.
If all calibrator replicates fall within expected limits the calibration curve is fitted and evaluated.
The accepted calibration curve is set to valid status and used in analytical runs.
If one or more replicates are out of limits, the software will apply a set of rules to judge if
calibration curve will still be evaluated and used or not, see Acceptance Rules.
Monthly Calibration
A calibration curve is established for each new lot number of conjugate. In case of EliA technology
the calibration curve is established for each new lot number of conjugate or if the code of the
calibrator well lot has changed. The obtained response curve is checked by the built-in control
functions of the system. If the response follows the defined rules for curve acceptance, the curve
is stored as active in the memory.
Calibration Curve
Calibration Curve
The conjugate lot number is linked to the stored active calibration curve. In subsequent assay
runs, as long as the same lot number of conjugate is used, the stored active calibration curve is
verified by using only two determinations of curve controls. If the curve controls fall within
acceptance limits, the instrument will assume validity of the used calibration curve and
consequently recommend acceptance of the appropriate analytical run.
The stored calibration curve is valid for the specific conjugate lot number as long as the curve
controls are within the limits or for a maximum time of 28 days.
Curve Controls
Curve Controls
ImmunoCAP / EliA methods use as a rule two different curve controls, which are determined in
a single replicate. Some ImmunoCAP / EliA methods use one curve control, which is determined
in a duplicate.
Assay Run and Analytical Run

Assay Run
An assay run on Phadia instruments is defined as the period of time from the point when the
process is started until the point when the process is ended by the operator. An assay run can
include a number of analytical runs.
Analytical Run (AR)
An analytical run in Phadia instruments is defined as a number of tests from the same method,
always calculated against the same calibration curve. The maximum length of an AR is defined
by method parameters. An AR can never extend through more than one assay run. The instrument
will automatically start a new AR for a method if the maximum length is reached, or if there is
a change in conjugate lot (and/or calibrator well code for EliA).
If a new conjugate lot (and/or calibrator well code for EliA) is used for the first time, a
determination and establishment of a new calibration curve will be performed at the start of the
new AR.
If a conjugate lot has been used earlier, and the existing stored calibration curve is valid, the
curve can be verified with curve controls.
Run Flow
Load and Start
When the operator selects the Load and Start/Assay command in the instrument software, a screen
will automatically be shown where the operator can select active methods that shall be processed
in the immediate assay run.
The selection from the previous assay run will remain. This means that if the same selection shall
be used in this new assay run, the operator only needs to confirm the selection.
After this screen, the operator will be informed what calibrators and/or CCs to load. For each
method, parameter settings and calibration status in the system decides if calibrators or curve
controls are needed.
If the instrument asks for curve controls for a certain method, it is possible to change this to
calibrators instead. It is not possible to change from calibrators to curve controls.
Routine Calibration
In General Parameters Group Box the operator can define how often a new calibration curve
will be run. Possible settings for this parameter are:
A Every Assay Run
B Every nth day
The default value is every 28th day.
In the example below the "nth" is set to every 2nd day.
Example of Assay Runs and Analytical Run layouts with different "interval settings".
Any assay run that was not assigned calibrators will be assigned curve controls instead.
These "routine" calibrators and curve controls are always started at the beginning of an assay
run.
Acceptance of an Analytical Run

In the Phadia system, numerous functions are checked before the analytical run is accepted or
not. If all these functions have performed within the specified limits, the analytical run is
recommended to be accepted by the operator.
There might be occasions when, for example, the curve controls are outside the expected signal
limits.
If the curve controls are Not OK, see the Acceptance Rules section.
Acceptance Rules
Self-check routines
Before each assay run the instrument will automatically perform a self-check of important
functions such as the assay blank.
Validity of Calibration Curve
Phadia system will automatically verify if the calibration curve or the curve controls are within
pre-programmed limits and give a recommendation to accept or not accept the validity of
calibration curve.
Acceptance of a Calibration Curve

Signal levels obtained from runs with calibrator points are subject to a curve fitting procedure
including examination of the obtained signal values against predetermined expected levels and
limits.
Description of obtained results and acceptance rules
When all calibrator replicates fall within expected limits the calibration curve is evaluated,
accepted as valid, stored and set as active:
The calibration curve will be judged as Calibration Curve OK.
When one calibrator replicate is outside the limits and thus is discarded, the calibration
curve will be evaluated, used and set as active:
The calibration curve will be judged as Calibration Curve OK.
When two or three calibrator replicates are Not OK and at least one of the replicates for
the lowest calibrator (for EliA the second lowest calibrator) is OK:
The calibration curve will be judged as Calibration Curve Partly Not OK.
The calibration curve will be calculated and accepted for this analytical run but will not be
stored. A new calibration curve must be run the next time.
When more than three calibrator replicates are Not OK or both replicates of the lowest
calibrator (for EliA the second lowest calibrator) are Not OK:
The calibration curve will be judged as Calibration Curve Not OK.
The operator will be requested to choose one of the following options:
Process new calibration curve now
Select calibration curve from log
Skip calculation and continue
Skip calculation and new tests will not be started.
Note: When this message pops up, dispensing of ImmunoCAP/EliA Wells is automatically
suspended for all methods until a selection is made.
Available options when Calibration Curve is Not OK
Process new calibration curve now
Phadia 250/1000 with a strip loaded: The processing of a new calibration curve is started
immediately.
Phadia 250 without a strip loaded: The message 'Could not start calibrators' is displayed. A
new calibration curve must be run in the next analytical run.
Phadia 1000 without strip loaded: The operator must load a new calibration curve strip, and
the processing of a new calibration curve is started.
Select calibration curve from log

A valid curve must be selected in IDM.
Skip calculation and continue

Dispensing of ImmunoCAP /EliA Wells is starting again.
No concentrations will be calculated for this method until a new calibration curve is run or a
valid curve is selected.
Skip calculation and new tests will not be started

Dispensing of ImmunoCAP/EliA Wells is permanently stopped in this run. All started tests
will be completed.
Acceptance of Analytical Runs

Assay runs with newly established and valid calibration curves are considered as accepted by
the system. Together with other assay performance parameters, such as Quality Controls within
limits, the included analytical runs are recommended to be accepted by the operator.
In assay runs with stored calibration curves, curve controls can be used. If obtained values for
the curve controls are within the pre-programmed limits, the calibration curve validity is verified
and the assay run is considered as accepted by the system. Together with other assay performance
parameters, such as Quality Controls within limits, the analytical runs are recommended to be
accepted by the operator.
Acceptance Rules for Curve Controls - In General

ImmunoCAP and EliA methods, as a rule, use two different curve controls, which are determined
in single replicate. Some methods use one curve control, which is determined in duplicate. In
both cases two curve control results will be obtained.
There are two levels of limits for acceptance of curve controls, inner and outer limits.
Limits for acceptance of curve controls
There might be occasions when the curve controls are outside the expected concentration limits.
In such cases the system will apply a set of rules to determine if the stored calibration curve is
still valid or not.
Acceptance Rules for Curve Controls

When one or two curve control replicates is High* or Low* (between inner and outer
limits High* + Low * is not allowed must be High* + High* or Low* + Low*):
The curve controls will be judged as Curve controls Partly Not OK.
- Process new curve controls now
- Process new calibration curve in the next run
Note: When this message pops up the dispensing of ImmunoCAP / EliA Wells will continue
and results will be calculated. A new calibration curve will be requested in the next analytical
run unless curve controls have been rerun and judged as OK.
Available options when Curve controls are partly Not OK
- Process new curve control now
Phadia 250/1000 with a strip loaded: The processing of a new curve control is started
immediately.
Phadia 250 without a strip loaded: The message 'Could not start curve controls' is displayed.
A new calibration curve must be run in the next analytical run.
Phadia 1000 without strip loaded: The operator must load a new curve control strip, and the
processing of new curve controls is started.
- Process a new calibration curve in the next run
The operator will be required to run a new calibration curve in the next run.
When curve controls are rerun in the next analytical run they must be judged as OK.
Otherwise a new calibration curve must be processed.
When re-measured curve controls are not OK:
The re-measured curve controls will be judged as Re-measured Curve Controls Not OK.
- Process new calibration curve now
- Select calibration curve from log
- Skip calculation and continue
- Skip calculation and new tests will not be started.
For an explanation of the different options, see 'Calibration Curve Not OK'.
When any replicate for a curve control is out of the outer limits or curve controls are
High* + Low* or Low* + High*:
The curve controls will be judged as 'Curve Controls Not OK'.
- Process new calibration curve now
- Select calibration curve from log
- Skip calculation and continue
- Skip calculation and new tests will not be started.
For an explanation of the different options, see Calibration Curve Not OK.
Note: A laboratory report with results can be prepared and printed when the analytical run is
ended regardless if the used calibration curve is accepted by the system or not. The decision to
accept an analytical run and thus the obtained results is the responsibility of the laboratory
manager. Other assay performance parameters, including the quality controls results, should be
used to support the decision.
However, if the warning system indicates problems with the calibration procedure, Phadia AB
strongly recommends the operator to follow the recommended procedures.
Process Monitoring
During assay there are several ways to monitor the process. This section gives a brief description
for some of the ways to monitor the process.
Overview of the Assay Run

In the IDM Workplace, click the appropriate instrument icon to display the Process tab.
The tab displays a graphical presentation of the current process. You can view the temperatures
in each part of the instrument. By moving the mouse pointer over each individual position, you
get detailed information what that position contain in a 'pop-up' speech box. You can move to
the previous position or following position with the arrow keys.
The error code field will display an error code when an error occurs. The wheel position will
then appear in red color. For explanation of error codes, see the IDM Error Codes section.
The window contains more tabs with different information about the ongoing assay and the
Phadia instrument. E.g. you can use the Process List tab for more detailed information about
tests currently processing as well as requested tests not yet started.
For more information about these functionalities, see IDM User Manual.
IDM Error Codes (Phadia 250)
Code Description Instrument action
300 Shortage of sample Test is aborted
301 Clogged sample Test is aborted
302 Shortage of ImmunoCAP/EliA Well (or dispense error) Test is aborted
303 Shortage of conjugate Test is aborted
304 Shortage of development solution Test is aborted
305 Shortage of other components or system liquids (i.e. other Test is aborted
shortage that 300 - 304 or 306-307.)
306 Shortage of stop solution Test is aborted
307 Shortage of diluent Test is aborted
310 LAS sample too late into position Test is aborted
400 Instrument error Test is aborted
401 Error in pre-wash Test is aborted
402 Error in sample pipetting Test is aborted
403 Error in sample wash Test is aborted
404 Error in conjugate pipetting Test is aborted
405 Error in conjugate wash 1 Test is aborted
408 Error in CAP transfer Test is aborted
409 Error in development solution pipetting Test is aborted
410 Error in stop solution pipetting 1 Test is aborted
413 Error in measurement module Test is aborted
414 Error in dilution Test is aborted
415 Error in stop transfer Test is aborted
500 Result is calculated against reagent blank that is out of limits Test is measured
600 Temperature in Immuno reaction chamber was out of limits Test is measured
601 Temperature in Enzyme reaction chamber was out of limits Test is measured
700 Sample incubation prolonged Test is measured
701 Conjugate incubation prolonged Test is measured
702 Development solution incubation prolonged Test is measured
710 Sample incubation critically prolonged Test is aborted
711 Conjugate incubation critically prolonged Test is aborted
712 Development solution incubation critically prolonged Test is aborted
801 Conjugate pipette surface detection error Test is aborted
802 Development pipette surface detection error Test is aborted
803 Warning in sample-pipetting Test is measured
Check Temperatures in Phadia 250

In the instrument software, press INFORMATION to see the temperature.
Press BACK to return to the previous menu.
Unscheduled Operation
Unscheduled Operations are operations that you normally do not have to execute, but is possible
to do. This section also contains information about Mixed Technologies.
Initialization
3. On the Utilities screen, select User Maintenance and press INITIALIZE.
Initialization starts and the Initializing screen appears. This will take about 2 minutes.
Handle Expiration Date

If expired reagents are loaded on the instrument, the instrument software will inform you about
this right after you have chosen methods to run by displaying an error message. This section
describes the handling of expired reagents with given examples.
To replace an expired reagent:
1. Close the error message.
2. Select the expired reagent in the Load screen and unload according to the instruction in
Unload/Empty.
3. Load a new reagent according to the instruction in Load Reagents.
You can choose to use one or more of the listed expired reagent for one more run. The Expired
Reagents screen will appear only when expired reagents are loaded. The list displays all loaded
reagents that have past expiration date.
To use an expired reagent for one more run:
1. Press EXPIRATION SETUP in the Load screen.
2. Use the checkboxes to the left in theExpired Reagents screen to select reagents (although
expired) that you want to use in one more run. Use the NEXT and PREVIOUS buttons or
arrow buttons to view all expired reagents.
Note: Use of expired reagents are not recommended by Phadia.
Note: If you use expired reagents, this will be printed in the reports and sent to the LIS.
Add Extra Calibrator/CC

During Assay Processing it is possible to add extra Calibrators and/or Curve Controls if a sufficient
amount of these reagents has been loaded before starting the assay.
Note: Extra Calibrators and/or Curve Controls cannot be loaded onto the instrument during an
assay.
1. Make sure that there are unused Calibrators and/or Curve Controls loaded on the instrument.
If not, this functionality cannot be performed.
2. On the Assay Processing screen, press EXTRA CAL/CC.
3. On the Extra Calibrator/CC screen, select Calibrator, or Curve Control, and Method.
As long as another Calibrator or CC is processing, the boxes are slightly gray. In that case it
is not possible to select a new CC or Calibrator.
4. Press ADD.
If Calibrators/CC are already loaded you will return to the Assay Processing screen.
If not, the Load screen will appear.
6. If you have setup more than one Strip Tray.
7. Activate the Manual barcode Reader by pressing the button left to it.
8. Read the barcode on the Strip Tray.
9. On the Strip Information screen, select a position by touching the field for empty strip.
10. Press UNLOAD.You will be prompted to confirm the action.
11. Unload the existing strip.
12. Take a new Calibrator/CC Strip according to the Load List.
13. Activate the barcode Reader by pressing the button left to it.
14. Read the barcode on the new Calibrator/CC Strip with the handheld barcode Reader.
15. Load the Calibrator/CC Strip vial into the flashing position on the Strip Tray.
16. Load the Strip Tray into the Strip Compartment.
17. Press BACK to return to the Load Reagents screen.
Pause Current Process

If a process is running and the PAUSE button on the instrument screen is active, it is possible to
pause the process.
1. Press PAUSE.
The process stops immediately and the key name changes to CONTINUE.
2. To continue, press CONTINUE.
Abort Current Process

If a process is running and the ABORT key on the instrument screen is active, it is possible to
abort the process.
Note: This applies to processes other than an assay. Do not abort an assay. For more information
about ending assays, see the Operation chapter.
1. Press ABORT.
The process will stop immediately.
2. You will be prompted to confirm the action.
Registered Loading Trays

Carriers are often transferred from the Loading Tray to the cooled Carrier Storage, as the on-board
stability is longer there than in room temperature. However, Carriers can also remain on the
Loading Tray during an assay run. The Loading Tray and the cooled Carrier Storage are then
treated as storage, and Carriers from both locations can be used in the same assay run.
Moreover, the system can register several Loading Trays. The system will keep track of the
Carriers in the registered Loading Trays also between assay runs, when they are not loaded on
the instrument. A registered Loading Tray containing Carriers is stored in the refrigerator between
runs and is loaded on the instrument when the Carriers are needed for a test. For example, a
registered Loading Tray may contain EliA wells while ImmunoCAP Carriers are loaded in the
Carrier Storage, if EliA is tested rarely.
Preferably, all Carriers to be used during an assay can be loaded on Carrier Loading Trays. Each
tray can be scanned to register the Carriers, and the tray is then stored in the refrigerator until it
needs to be loaded. Once the Loading Tray on the instrument has been changed, the Carriers are
already registered and displayed on the instrument screen and need no further handling.
Description of Registered Loading Trays

The Registered Loading Tray functionality includes the following features:
Registers up to 10 scanned Loading trays, Tray 01 to Tray 10.
Ability to unload and load individual Carriers to a registered and unloaded tray.
Ability to change Loading Tray during assay.
Monitors time since each Carrier was loaded.
Discards empty Carriers to Waste Container.
Compatibility with the Wait Refill function.
Common prioritization among all Carriers on the instrument.
Note: If there are carriers of the same type in both the Loading Tray and the Carrier Storage,
the system identifies and uses the carrier with the highest priority. E.g., a carrier that has been
used earlier is used until empty before the system starts to use a full carrier.
Carrier Loading Tray Screen

This screen is reached by pressing LOAD in the Start Menu screen and then pressing
ImmunoCAP/EliA Well Carrier Loading Tray in the Load screen.
Part Function
Carrier ID Field displays the ID of the selected Carrier.
Unload Carrier Unload the selected Carrier.
Carrier Loading Tray ID Field displays the ID of the loaded Loading

Tray.
Color code The Carriers in the illustration to the left are

color coded according to status: Not loaded,
Full, In Use, Empty and Error/Expired.
Carrier table Table displays information about each carrier.
Start transfer to storage Loaded Carriers are transferred to Carrier

Storage.
Edit doses Set number of doses in previously used Carrier.

Note: Carriers in registered Loading Trays are
logged. Manual edit of these is not necessary.
Clear Tray All Carrier positions will be set to Not Loaded.
Toggle to open the alternative keys.
Unlock The tray is unlocked in order to remove the tray

from the instrument and unload or load Carriers.
Expiration Setup Handle expired Carriers.
Scan Load Tray The tray is locked and used as storage. All
Carriers are registered.
Back Return to the Load screen.
Information View the Information screen.
Register and Load a Carrier Loading Tray

Preferably, all Carriers to be used during an assay are loaded on Carrier Loading Trays. Each
tray is scanned to register the Carriers, and the tray is then stored in the refrigerator until it needs
to be loaded. Once the Loading Tray on the instrument has been changed, the Carriers are already
registered and displayed on the instrument screen and need no further handling.
To load and register a tray is similar to loading a tray without Carrier registration. Follow the
instruction below to load and register an empty Loading Tray. For information about loading
additional Carriers to a tray that already contains registered Carriers, see Load Additional Carriers
.
2. On the Load screen, select ImmunoCAP/EliA Well Carrier Loading Tray.
3. Press the Carrier Loading Tray ID field.

Result: A list of ten Loading Trays is displayed in the Select Carrier Loading Tray screen.
4. Select the desired Tray ID and press SELECT TRAY. Empty trays have 0 in the Loaded
position column.
Result: Information about the selected tray is displayed on the Carrier Loading Tray screen.
5. Verify that the tray on the screen is empty. If not, select another Tray ID.
6. Collect Carrier according to the Load List.
7. Load Carriers in the Carrier Loading Tray. Start with position 1 (left row, rearmost position),
fill row by row from left to right.
Note: If any Carriers contain less than full quantity of tests, these must be placed first and
the quantity manually changed according to Use Manual Barcode Reader and Edit Doses in
Carrier .
9. Press the TOGGLE Key.
10. Press SCAN LOAD TRAY and then press OK.

Result: The tray is locked and all Carriers are scanned.
11. If more Carrier Loading Trays will be used during the assay, register the remaining trays:
Press UNLOCK.
Remove the tray and store it in the refrigerator.
Repeat the instruction from step 3.
Note: Always unlock the registered Carrier Loading Tray after a run and store it in the refrigerator.
Change Loaded Tray

Follow the instruction below to change from a Loading Tray to another. This may be performed
before or during an assay run.
Note: Each instrument keeps track of up to 10 Loading Trays. Registration is instrument-based.
If there are two instruments connected to IDM, information about the registered trays on the first
instrument is not automatically copied to the other instrument.
Note: It is important to verify that the correct Loading Tray ID is selected on the screen. If a
carrier is missing for a test, the test is skipped. If an incorrect carrier has an invalid barcode, the
system will use the carrier and not identify the error. This situation will lead to incorrect results
without notification.
2. Remove the tray and store it in the refrigerator.
3. Collect the desired tray from the refrigerator.
4. Press the Carrier Loading Tray ID field.
Result: A list of registered Loading Trays is displayed.
5. Select the desired Tray ID and press SELECT TRAY.
Result: Information about the selected tray is displayed on the Carrier Loading Tray screen.
6. Verify that the tray on the screen contains the same reagents as the physical tray.
8. Press the TOGGLE key.
Result:
Before assay: The Loading Tray is locked and treated as a storage area. Transfer of Carriers
from the loading tray to the storage tray is prevented. Scanning of the Loading Tray starts
at the position after the last registered Carrier. Scanning ends after two consecutive empty
positions.
During assay: The Loading Tray is locked and treated as a storage area. Transfer of Carriers
from the loading tray to the storage tray is prevented. No scanning is performed.
Note: In the described procedure no additional Carrier is added to the registered tray. In order
to load additional Carriers before an assay, see Load Additional Carriers . In order to load
additional Carriers during an assay, use the Manual Barcode Reader as described in Use Manual
Barcode Reader and Edit Doses in Carrier . In order to load missing Carriers after an error
message, see Load missing Carrier on Registered Loading Tray .
Load Additional Carriers

Follow the instruction below to load additional Carriers to a Registered Loading Tray, before
starting an assay run. The Carrier Loading Tray must be unlocked and removed before a Carrier
can be unloaded or loaded on the tray.
2. Remove the tray.
3. If any Carriers contain less than full quantity of tests, use the Manual Barcode Reader, edit
the number of doses left and load them in the tray, as described in Use Manual Barcode Reader
and Edit Doses in Carrier .
4. Place full Carriers in empty positions on the tray. Do not leave more than two empty positions
between two Carriers.
6. Press the TOGGLE Key.

Result: The Loading Tray is locked and the transfer of Carriers from the loading tray to the
storage tray is prevented. Information about previously loaded Carriers remains. Scanning of
the Loading Tray starts at the position after the last registered Carrier. Scanning ends after
two empty positions.
8. To exit the registration and enable transfer to Carrier Storage, press UNLOCK, remove the
Loading Tray and press Clear Tray.
Note: Carriers with barcodes that have been read using the Manual Barcode Reader will not be
scanned, but are already displayed on the screen and registered.
Load missing Carrier on Registered Loading Tray

Either the Carrier can be discovered to be missing before it is needed in the assay, or the instrument
will alarm with an error message when it is needed. In the first case, it is possible load the Carrier
using the Manual Barcode Reader. If the error message is displayed, it is possible to use the
functionality Wait Refill.
In both cases, it is important to use the Manual Barcode Reader. No scanning will be performed
during an assay. Make sure to select SCAN LOAD TRAY instead of TRANSFER TO STORAGE
in order to keep the Carrier on the tray.
Note: If Test Pass has previously been selected for a test, the test will not automatically start if
a Loading Tray with the correct Carrier is loaded. The Sample Rack must be reloaded first.
For information about loading Carriers during an assay run, see Use Manual Barcode Reader
and Edit Doses in Carrier .
For information about Wait refill, see Load Missing Carrier.
Unload Carrier From Loading Tray

Follow the instructions below to unload an individual Carrier from the Loading Tray. This Carrier
will no longer be registered. The Carrier Loading Tray must be unlocked and removed before a
Carrier can be unloaded or loaded on the tray.
2. Remove the tray.
3. Select Carrier to remove in the illustration on the left hand side of the Carrier Loading Tray
screen.
Result: The corresponding position in the right hand side table is highlighted.
4. Press UNLOAD CARRIER.
Result: The Carrier is removed from the illustration and the table.
5. Remove the Carrier.
6. Push the Carrier Loading Tray onto the instrument or store the tray in the refrigerator.
Note: The Carrier can be selected from the illustration or the table.
Unload and Clear Loading Tray

Follow the instruction below to unload and clear the Loading Tray. The Carriers in the Loading
Tray will no longer be registered.
Note: To only unload the Loading Tray and not unregister the Carriers, only perform steps 1
and 2.
1. Press UNLOCK.
2. Remove the tray.
3. Press Clear Tray.
Result: The Carriers are no longer registered and the displayed Tray information is cleared.
4. Discard of empty Carriers and store the tray in the refrigerator.
Unload Carrier Loading Tray After a Run

Always unlock and remove the registered Carrier Loading Tray after an assay run and store it in
the refrigerator.
Unload Empty Carrier from Carrier Storage

Empty and low frequency tests are automatically unloaded from the Carrier Storage after assay
when the Carrier Storage is used as the only storage area, if the function is enabled in the parameter
settings.
Automatic unloading of empty and low frequency test is not available when the Carriers on the
Loading Tray are registered and the Loading Tray is locked. No Carrier can be transferred to or
from the Carrier Storage during this mode. The Carrier Loading Tray must be unlocked and
removed, and another empty tray loaded before performing unloading of Carrier, see
Unload/Empty.
Transfer Registered Carriers to Carrier Storage

Follow the instruction below to enable transfer of all Carriers on a loaded and registered Carrier
Loading Tray to Carrier Storage. The information about the Carriers will remain in the system.
1. Press UNLOCK.
2. Press Transfer to Storage.
Result: The Carriers are transferred to Carrier Storage. The Tray information is cleared, but
the data is moved to the Carrier Storage information.
Load Conjugate Tray

1. Take out the Conjugate Tray from the refrigerator.
5. If a Conjugate Tray is already loaded, unload that tray from the Conjugate Compartment.
6. If you have set up more than one Conjugate Tray.
7. Press the Manual barcode Reader to activate it.
8. Read the barcode on the Conjugate Tray.
9. Load the Conjugate Tray into Conjugate Compartment.
Load Strip Tray
1. Take out the Strip Tray from the refrigerator.
2. Go to Start Menu on the Instrument by pressing BACK till you get there.
3. In Start Menu Select LOAD.
4. In Load select STRIP TRAY.
5. If you have a Strip Tray already loaded, unload that tray from the Strip Compartment.
6. If you have setup more than one Strip Tray.
8. Read the barcode on the Strip Tray.
9. Load the Strip Tray into Strip Compartment.
10. Press BACK and to return to Load.
Load Missing Carrier

If one or more ImmunoCAP and/or EliA Wells are missing when they should be dispensed, the
instrument will display an error message (Error 0-1055). If the needed carriers are available and
can be loaded, use the Wait Refill functionality as described below.
Note: Wait refill is available for patient tests. It is not applicable for QC tests. All relevant
Carriers must be loaded before the assay starts in order to perform QC tests.
Note: For registered Carrier Loading Trays, the Manual Barcode Reader must be used even
though SCAN LOAD TRAY is selected to lock the tray. No scanning will be performed during
an assay.
1. Press WAIT REFILL in the Error screen.
Result: The Wait refill selection screen opens.

2. Select the checkboxes beside the tests that will be loaded. Tests that are not selected will be
set to Test Pass (not performed).
3. Press WAIT REFILL to confirm selection.
4. Press LOAD on the Assay Processing screen when available.

6. Remove the Loading Tray.
7. Read the barcode of a new Carrier with the Barcode Reader.
Result: If the barcode is recognized, a position in the illustration on the left hand of the Carrier
Loading Tray screen flashes with green color.
8. Place the new Carrier in the corresponding empty position on the tray.
9. Repeat steps 7 and 8 for all new Carriers.
11. Press
START TRANSFER TO STORAGE to transfer the Carriers to the Carrier Storage, or
SCAN LOAD TRAY to keep the Carriers in the tray. This alternative is used for registered
loading trays, see Registered Loading Trays .
Result after START TRANSFER TO STORAGE: Tests that are set to usage frequency High
will be transferred to storage and then dispensed from there in to the process. Tests that are
set to usage frequency Low will be dispensed from the Loading Tray in to the process. The
Wait Refill request is then able to start.
Result after SCAN LOAD TRAY: The tray is locked. The Wait Refill request is then able to
start.
Note: For more information about usage frequency, see Set Usage Frequency .
Note: If Test Pass has previously been selected for a test, the test will not automatically start if
a Loading Tray with the correct Carrier is loaded. The Sample Rack must be reloaded first.
Set Usage Frequency

It is possible to set the usage frequency for a certain Carrier. Tests that are set to usage frequency
Low will be dispensed from the Loading Tray in to the process, instead of being transferred into
the Carrier Storage. Follow the instruction below to set the usage frequency.
1. In IDM Workplace, click F8 - SYSTEM.
Result: The System window will open.
2. Select the Methods tab.
3. Select the wanted method and click OPEN.
4. Select the Tests tab.
5. Select the wanted test and click OPEN.
6. In the Test window, select the Miscellaneous tab.
7. Select High or Low from the Usage Frequency drop list.
Move Sample Rack Content

The Sample information can be moved from one Sample Rack to another. This can be useful
when using Samples with unvalid Barcodes.
1. Select the current empty Sample Rack in the Rack List window.
Result: The Rack ID window opens.
2. Click the Get Content button.
Result: The Get Rack Content window opens.
3. Enter the ID of the Sample Rack that you want to move the content from. Then click OK.
Result: The content in the selected ID is moved to the current ID.
Multiple Rack Selection

Follow the instruction below to select several Sample Racks to Delete, Clear or Configure.
Multiple Quality Control Racks can be selected in the same manner to Delete or Clear.
1. Open the Rack List Window.
2. Click on the first Rack of interest.
3. Press down the ctrl key while clicking on all remaining Racks of interest.
Result: The Racks are selected.
4. Click the Delete, Clear of Configure button.
Result: All the selected Racks are deleted, cleared or selected for configuration.
Note: For information about rack configuration, see Configure Sample Rack.
Filter Rack List

The Rack List can be filtered to list racks according to certain search criteria.
The filter criteria are found in the right-hand menu and comprise the following features:
All
Sample
QC
Configure profile
Minor allergens
Consumables
Note: Minor allergens are tests that are set to Usage Frequency Low in the System window.
1. The filters are displayed in the menu and in the sub-menu:
For filter based on All, Sample or QC Rack, click the desired radio button in the right-hand
menu and continue to step 3.
For filter based on Configure profile, Minor allergens or Consumables, click the Menu
button to display the sub-menu.
2. Click on the desired filter button in the right-hand sub-menu.
3. View the filtered Rack List, with altered heading according to filtration. In this example,
Minor allergens is filtered.
4. Click Print to print the list, if desired.
Loading Reagents During an Assay Run

In assay runs where the instrument performs a lot of dilutions, especially when the EliA technology
is used, the throughput of tests will decrease. The reason is that the amount of reagents needed
for optimal throughput of tests cannot be loaded before the assay run is started. You can solve
this problem by loading the dilution plates, development solution and diluent during the assay
run. The procedure for doing this is described below.
To get access to the features for performing these actions, you need to enter the correct settings
in your Phadia 250 Instrument Software (ISW).
Note!
To avoid the risk of operator injury or loss of test results, it is very important to perform the
loading of reagents according to this description.
Important Preparations
Before you can use the feature for loading reagents during an assay run, the Phadia 250 instrument
software must be set up correctly. This is can be done only by service engineers or Phadia
representatives.
Proper training of the operator is also required before access to the feature will be granted. Contact
your local Phadia representative for training and instrument setup.
Loading Development Solution

When needed, you can load a new development solution bottle during an assay run. You must
do this exactly as described here. Do not try to perform the loading in a different manner, because
doing this may cause unwanted response from the instrument and could lead to loss of results
and/or operator injury.
It is recommended to start the run with 2 full development solution bottles loaded.
Bottle 1 can be in use, but bottle 2 must always be full when the assay run is started.
Only one bottle can be reloaded on each occasion: the bottle the instrument is not pipetting from.
Do not load both development solution bottles at the same time during an assay run.
Note: Make sure that the instrument is correctly set up before starting an assay run, and that the
operator is properly trained.
Note: Blank measurement of the new bottle will not be performed during an assay run. The
operator is required to check the blank value before starting the run. The blank value used is the
blank value measured for the bottle that was placed in this position at the start of the assay run.
Reagent Loading Procedure

The following message (2-183) will appear when a development solution bottle is empty and it
is time to initiate the loading of a new bottle. When this message appears, press the CLOSE
button and load the bottle as soon as possible.
1. To initiate the loading of a development solution bottle, press the LOAD key on the Assay
Processing screen.
3. Press the LOAD key on the Development/Stop Solution Information screen to initiate
development solution loading.
4. Press OK on the Confirmation screen.
It may take up to 90 seconds before loading of the development solution can be performed.
Loading is allowed only at the point of the work cycle when the left moving arm is positioned
furthest away from the development solution and stop solution storage.
No further confirmation window is displayed during the 90 seconds. When the instrument is
ready, and loading is permitted, the instrument will provide the information below.
5. Message 2-182 appears and the instrument gives signals by means of sound and yellow light.
When this message appears, ImmunoCAP/EliA Well dispensing is halted for one position and
then reinitiated.
6. Now unload the empty development solution bottle, accessing the instrument from the left.
Avoid by all means reaching into the right area, highlighted in red in the picture above, where
the right moving arm is still moving (pipetting).
The empty bottle is the bottle displayed in green color on the Development/Stop Solution
Information screen. This is the empty bottle not used for pipetting mentioned in Message
2-183 above. Remember that the color changes from yellow (in use) to green (full) as soon
as the instrument starts pipetting from the other bottle.
7. Load a new full development solution bottle without reading the barcode from the left. Place
it in the empty position from where you just removed the empty bottle. The time allowed for
doing this is approximately 25 seconds, not longer! This step is performed by accessing the
instrument from the left only.
8. When done, press CONFIRM to close the message 2-182 and let the instrument return to
normal assay operations. Now the instrument is once again able to access development solution
and stop solution. If you do not press CONFIRM, the left moving arm will not move back to
the development/stop solution storage, and affected tests in the Enzyme Reaction Wheel
(ERW) will be flagged and results will be lost.
Do not press CONFIRM until you have unloaded the empty development solution bottle and
loaded a full one. By pressing this button you confirm that the loading has finished and tell
the instrument to return to normal operation mode, meaning that the left moving arm will
return to its normal operational behavior.
Note: By pressing CONFIRM you tell the instrument that a new development solution bottle
is loaded. If you initiate this feature and confirm the message, the instrument will think that
a new bottle is loaded even if you have not loaded a new one.
Note: Only load new, full bottles. The time allowed for unloading and loading is only 25
seconds. If the time limit is exceeded, affected tests will be flagged (and results lost) until you
press CONFIRM.
Note: To avoid operator injury, access the instrument only from the left hand side when
unloading or loading the development solution bottle. Both moving arms are still active, even
though the left moving arm does not reach as far as to the development/stop solution storage
area.
Note: ImmunoCAP/EliA Well dispensing is put on hold for one minute, and after that it is
resumed, meaning that new tests will be dispensed and processed.
Load Dilution Plates and Diluent

When needed, you can load new dilution plates and/or diluent bottles during an assay run. You
must do this exactly as described here. Do not try to perform the loading in a different manner,
because doing this may cause unwanted response from the instrument and could lead to loss of
results and/or operator injury.
Note: Make sure that the instrument is correctly set up before starting an assay run, and that the
operator is properly trained.
The instrument will not warn or inform when it is time to initiate the exchange of dilution plates
or the loading of a new diluent bottle. This feature is completely manual, and the operator is
responsible for performing the loading of new dilution plates and/or a new diluent bottle in time.
When the instrument runs out of dilution wells in the dilution plates and/or diluent, the dispensing
of new ImmunoCAP/EliA Wells will stop. Also keep in mind that, depending on the number of
ImmunoCAP/EliA Wells in the Immuno Reaction Wheel (IRW), it can take up to 40 minutes
before loading is possible.
Note: Loading of a new diluent bottle requires an empty position in the diluent tray. Unloading
of an empty bottle is not possible during assay.
Diluent and Dilution Plate Loading Procedure

1. To initiate the loading of dilution plates and/or a diluent bottle, press the LOAD key on the
Assay Processing screen.

3. Press LOAD on the Diluent screen to initiate dilution plate and diluent bottle loading.
4. Press OK on the Confirmation screen.
Note: If you press BACK on the Diluent screen, you will end the loading procedure.
Depending on the number of ImmunoCAP/EliA Wells in the IRW, it will take up to 40 minutes
before loading of reagents can be performed.This is due to the fact that all started tests in the
IRW wheel must pass the conjugate pipetting position before loading is possible.
Note: No confirmation screen is displayed until loading is possible (up to 40 minutes). It is
not possible to leave the Diluent screen during this time without aborting the loading procedure.
5. After the last dispensed ImmunoCAP/EliA Well has passed the conjugate pipetting position,
loading is allowed. The instrument will signal this by means of a yellow light and a sound,
and message 0-1194 will appear. The process can be supervised from IDM, and the operator
can tell how much time is remaining until loading is available (see the picture above, all
samples must pass the Conjugate position in the IRW).
Loading of dilution plates and diluent is now available. The right moving arm will be inactive
and positioned in the right corner. The left moving arm will work as usual.
During unloading and loading, the instrument must be accessed from the right side only. Avoid
by all means reaching into the area highlighted in red, where the left moving arm is still active
(pipetting).
Note: Do not open the safety guard during loading! The left arm will stop working, and for
that reason there is a risk of losing results.
6. Close the Message screen by pressing CLOSE, and then perform the loading procedure.
Loading a Diluent Bottle

Loading of diluent requires that at least one empty position is available in the diluent tray.
Load a new, full bottle as usual by reading the barcode label and placing the bottle in the empty
(flashing green) position.
Note: When loading, access the instrument only from the right hand side since the left moving
arm is still working.
Note: Unloading of an empty diluent bottle is not possible during assay.
Loading Dilution Plates

1. If the Diluent screen is displayed, press DILUTION WELL to open the Dilution Well
Information screen.
2. On the Dilution Well Information screen, press CLEAR to clear the instrument memory of
used dilution plate positions.
Note: All information about both plates will be cleared. This means, that the information
stored in the ISW about used positions in both plates will be cleared and both plates must be
reloaded.
3. Press OK on the Confirmation screen to confirm the unloading of the dilution plates.
4. Unload both dilution plates.

Note: Since the left moving arm is still active, access the instrument only from the right hand
side when unloading.
Note: When removing the dilution plates, do not move them over the sample loading area.
Any kind of spillage from the dilution plates can lead to contamination of the samples.
5. When unloading the dilution plates, Error Message 0-1182 will be displayed twice, once for
the dilution plate in position 1 and once for the plate in position 2. Press CLOSE on each
message screen.
6. Load new empty dilution plates in position 1 and position 2.
side when loading.
7. When you are finished loading new dilution plates, press BACK on the Dilution Well
Information screen. The Diluent screen will open.
8. On the Diluent screen, press BACK to exit the loading feature.

9. Confirm that you are finished loading dilution plates and/or diluent by pressing OK on the
Confirmation screen.
The instrument will return to normal mode and the dispensing of new ImmunoCAP/EliA
Wells will start.
side when unloading and loading to avoid operator injury.
Note: During loading of dilution plates and/or diluent, the ImmunoCAP/EliA Well dispensing
will be halted until you exit the function. The longer the loading takes, the more throughput
will be lost.
Replace Carrier Storage Tray

1. Go to Start Menu on the Instrument by pressing BACK until you get there.
3. On the Load screen, select ImmunoCAP/EliA Well Carrier Storage.
4. On the Carrier Information screen, press CARRIER STORAGE TRAY. If the key is not
visible, press the TOGGLE key.
Unload
1. On the Carrier Storage Tray screen, select the tray to unload.
2. Press LOAD/UNLOAD.
3. The selected tray will be moved to load/unload position. The position will be displayed in
grey on the Carrier Storage Tray screen.
4. Lift the Protection Hood.
5. Open the storage cover.
6. Unscrew the locking pins until they come free.
7. Unload the tray by lifting it by the locking pins.
If you are not going to load now

1. Close the cover.
2. Close the Protection Hood.
Load
1. On the Carrier Storage Tray screen, select one of the trays not loaded,
or
Read the Barcode of the tray you want to load. The Carrier Storage Tray screen will appear.
2. Press LOAD/UNLOAD.
3. The empty position will be moved to load/unload position.
4. Open the storage cover.
5. Load the tray by lifting it by the locking pins, tighten the locking pins.
6. Close the cover.
7. Close the Protection Hood.
Note: If you load the Tray without reading or entering the barcode the position will be yellow
(as Tray loaded) but there is no ID for the Tray in column Tray ID. Always define (read or enter)
ID before you load a Storage Tray.
Wash Volume Check
Correct wash volume in the washing steps is important for reliable results, especially for EliA
tests. Wash Volume Check verifies that the wash volume dispensed by the washing stations is
within acceptable limits.
Wash Volume Check can be performed either automatically at assay start, if the corresponding
system parameter is set to ON, or by selecting the volume check in Super User Maintenance
as described below.
Perform Wash Volume Check

Follow the instruction to perform Wash Volume Check. Super User access is required.
1. Make sure that at least 20 Xummy wells are loaded in the Carrier storage.
2. In the Main screen, press UTILITIES.
3. In the Utilities screen, press SUPER USER MAINTENANCE.
4. In the SUPER USER MAINTENANCE screen, press Functional test.
Result: The FUNCTIONAL TEST screen opens.
5. In the Functional test screen, press WASH VOLUME CHECK.

Result: Wash Volume Check screen opens.
6. In the Wash Volume Check screen, press START.
Result: The check starts.
7. Read the result in the Wash Volume Check screen after Wash Volume Check completion.
If Wash Volume Check is OK, continue as desired.
If Wash Volume Check is Not OK, follow the instructions in the section below.
If Wash Volume Check is Not OK

If the Wash Volume Check result has failed, contact your local Phadia representative for assistance.
Note: Running an EliA assay after failed Wash Volume Check is not recommended. The test
result may be affected.
To perform an assay run despite of failed Wash Volume Check, make first sure that other quality
parameters are within acceptable limits.
Mixed Technologies
1. If both ImmunoCAP and EliA technologies are used in the same run, the ImmunoCAP and
EliA in the same Run screen will appear after you press NEXT on the Check
Waste/Rinse/Wash Bottles screen.
2. On the ImmunoCAP and EliA in the same Run screen, use the Start with keys to select the
technology to start with. Use the Change technology keys to select automatic or manual change
of technology.
3. Press START to confirm the selection and to start the assay.
If MANUALLY was selected, the Confirm Change Technology screen appears when all
requests for the first technology are started. The technology change is performed only when
the step is confirmed on the Confirm Change Technology screen.
If AUTOMATICALLY was chosen, information about the technology change will be given
on the display. The current technology is used as long as there are non-started requests for
the technology. A manual change of technology during the assay is also possible if the
Automatically mode is seleced and you press the CHANGE TECHNOLOGY key on the
Assay Processing screen.
Selecting automatic change might cause several changes.

Changes between the technologies will be divided by a gap. The gap will be 15 minutes (15
empty positions) if technology is changes from ImmunoCAP to EliA and 30 minutes (30 empty
positions) if technology changes from EliA to ImmunoCAP.
Note: Switching back and forth between technologies will consume a lot of time and also racks
be locked and you run out of free spaces to load new racks.
Running two technologies in the same assay, demands loading of samples for the first technology
first, and then loading samples for the second technology not to cause problems with locking of
racks, several changes (time consuming) and to be efficient.
Quality Guide
Introduction
Accurate and reliable measurements of biochemical markers are needed for making a good
diagnosis.
These measurements must be done within a cost-effective and reliable framework justifiable to
patients, doctors and health authorities.
The laboratories performing in vitro tests can fulfill these demands and ensure that correct results
will be obtained by adapting a solid quality assurance program in the laboratory.
This guide gives an introduction to procedures for how to establish and use such programs in
laboratories using Phadia system for in vitro allergy, asthma and autoimmunity testing.
Quality Assurance
The American Society for Quality Control defines quality assurance as "all those planned or
systematic actions necessary to provide adequate confidence that a product or service will satisfy
given needs" (Glossary and tables for statistical quality control, Milwaukee, WI: American
Society for Quality Control, 1983).
Quality assurance of an in vitro allergy or autoimmunity test procedure involves 4 steps.
1. Documentation and implementation of routines regarding:
Handling of samples (type, collection, identity, transportation, storage, handling).
Calibration and maintenance of equipment (instruments).
Handling of reagents (ordering, transportation, storage, use).
Acceptance and reporting of results.
2. Training and 'validation' of operators
The laboratory staff has to go through a training program before a new method can be used
for routine testing.
3. Internal quality control (control charts)
The control samples are assayed in each run and the results are plotted against run number
(or time). Such a plot is generally called a Quality chart.
4. External quality assessment
Participation in external quality assessment programs is a prerequisite for obtaining information
about accuracy. The same samples are assayed by, preferably, all laboratories using the same
method.
For steps 1 and 2, a Phadia representative can help and advise laboratories to ensure the best
performance. Also selected areas are covered in this manual.
For steps 3 and 4, Phadia AB has developed special products and procedures for the laboratories.
These will be discussed in more detail in this chapter.
Basic Concepts
Measurements
A measurement is a set of operations used in determining the value of a quantity. In clinical
chemistry, the value is the concentration of an analyte in a sample (specimen).
The observed response from an assay is transformed to concentration via a calibration curve
estimated from assays of calibrators with known concentrations. A set of assays performed on
one occasion and evaluated with the same calibration curve is called an analytical run.
Measurements
Basic Statistics
The value obtained after a measurement is called a test result. When repeated measurements are
performed, the arithmetic mean is usually calculated. As a measure of imprecision, the standard
deviation or coefficient of variation is used.
If n individual test results are denoted by x1, x2,....xn, the mean, standard deviation (SD) and the
coefficient of variation (CV) are calculated and denoted as follows:
The individual results can be illustrated by a frequency distribution, often of the bell-shaped
Gaussian type. For such a distribution, about 95 % of the values are within mean 2 SD and
about 99 % within mean 3 SD.
Frequency distribution of Gaussian type
Obtained values should be related to the true value (or accepted reference value) which can be
defined in terms of:
1. An assigned value based on experimental results with a reference method.
2. A reference preparation with an assigned value, made by an internationally recognized authority,
e.g. WHO.
3. A consensus value based on collaborative results with the actual method.
As there are no generally accepted international reference methods for Total IgE and Specific
IgE, Specific IgA, and Specific IgG, ECP, and Tryptase, the true values for these methods are
determined according to (2) and (3).
Variation in Results
The variations of measurements are usually assumed to consist of two components.
A systematic component that remains constant in the considered set of measurements.
A random component that varies in an unpredictable way.
The variation in results may be caused by intrinsic factors within the testing procedure, or by
extrinsic factors. To be able to get high-quality results from an analytical run, it is essential to
recognize these different factors and understand their influence.
Examples of Sources of Variation

Samples: Identification, type, collection, preparation, transportation, storage and handling.
Equipment: Calibration and maintenance of equipment.
Calibrators and reagents: Within, and between batch variation, transportation, storage, expiration
dates and handling.
Performance and performance conditions in customer laboratories. This is usually a function
of laboratory routines (assay run according to Directions for Use) and training of the laboratory
staff.
Sources of variation
Accuracy and Precision

The relationship between obtained results and true values are defined in terms of 3 factors.
Accuracy: How close the agreement is between obtained results and the true value. Accuracy
describes a combination of random components and a common systematic error.
Trueness: How close the agreement is between the mean value obtained from a large series of
test results and the true value. The measure of trueness usually is expressed in terms of a systematic
error (also called bias).
Precision: How close the agreement is between independent test results obtained under prescribed
conditions. Precision is usually expressed in terms of standard deviations, however the relative
standard deviation, i.e. the coefficient of variation (CV), is often more relevant for in vitro testing.
Accuracy, trueness, and precision
Quality Controls
Quality Controls are provided for all the methods used in Phadia System.
The Quality Controls are optimized to be used in our Instruments.
The Quality Controls are predefined in each method for easy handling and it is easy to add
information on lot numbers and limits used.
The Quality Controls are barcode labeled for secure identification.
The software is automatically saving results, charts and statistics for the Quality Controls
which are used for follow-up of the method quality.
For each run the Quality Control results are presented in comparison with limits for acceptance.
Use Quality Controls to monitor long term variation.
Quality Controls have been run at Phadia AB and the acceptance range values are stated in the
Directions for Use (DfU), on the label of the QC bottle, or on the certificate that the QC bottle
package contains.
QC rules are used in order to interpret the QC results and to guide the operator for a sufficient
action when deviations have occurred.
Good laboratory practice dictates that every precaution must be taken to avoid evaporation and
contamination. It is recommended to take out and recap the QC vial as soon as possible. Repeated
freezing and thawing should be avoided.
Note: EliA Quality Controls are single use and have to be discarded after the assay run.
Note: All products are not available in all countries.
Handle ImmunoCAP Quality Controls
Recommendation how to use the Quality Controls for ImmunoCAP, and what result to expect,
is provided below. For information about the available Quality Controls, see the corresponding
Directions for Use or contact your local Phadia representative.
Control setup and CV: The table below shows the recommended control setup for each method
and what variation, CV, to expect.
Method Control set Expected variation, CV
ImmunoCAP Specific IgE 3 levels and 1 negative <8%1, <12%2
ImmunoCAP Total IgE 3 levels <10%2
ImmunoCAP Specific IgG 3 levels <15%2
ImmunoCAP Specific IgG4 2 levels <15%2
ImmunoCAP ECP 1 level <10%2
ImmunoCAP Tryptase 1 level <10%2
Autoimmunity ImmunoCAP 3 levels <15%2

Specific IgG
1
Short term. Within batch and monthly calibration.
2
Long term. Between batch and monthly calibration.
About precision: Higher CV% is often caused by unstable environmental conditions in
combination with the Monthly Calibration concept. Using Quality Control vials that have been
uncapped for a long time in the instrument, causing high evaporation and thereby increased
concentration, can contribute to higher variation in results.
Frequency: The Quality Controls must be run routinely in order to monitor variation and obtain
reliable measurements.
Instrument Frequency within Assay Run

Phadia 250 Each control set in the beginning of each Analytical run and in
the end of Assay Run. If an extensive Assay Run is performed,
then also after every 100 tests.
Phadia 1000 Each control set in the beginning of each Analytical run and
then after every 200 tests.
Handle EliA Quality Controls
For information about the available Quality Controls, see the corresponding Directions for Use
or contact your local Phadia representative. The EliA Quality Controls are ready for use and
should not be further diluted.
About precision:Higher CV% is often caused by unstable environmental conditions in
combination with the Monthly Calibration concept. Using Quality Control vials that have been
uncapped for a long time in the instrument, causing high evaporation and thereby increased
concentration, can contribute to higher variation in results.
Quality Control Targets and Limits

When a new QC is introduced, use limits stated in the Directions for Use, on the QC bottle label,
or on the certificate that the QC bottle contains.
Establish your own mean value from at least 20 runs. It is recommended that each customer
establish their own target values. Recommended range is +/- 30% which corresponds to 2 SD
limits for ImmunoCAP Specific IgE, Specific IgG, Specific IgG4 and for ImmunoCAP
Autoimmunity and to 3 SD limits for ImmunoCAP Total IgE, ECP and for ImmunoCAP Tryptase.
After using this range for a year, establish QC limits using the SD from your QC statistics.
When changing to a new QC lot number, establish a new mean value and calculate limits using
the %CV from previous lot number.
2 SD is a warning limit for the method. An investigation should be made to analyze if something
is wrong with the instrument or if other things are affecting the quality of results. Note that it is
normal for 5% of the observations to be outside the inner limit (2 SD). When a systematic drift
is visible, it is advisable to run a new calibration curve after having checked curve control data.
Note that curve controls only check the validity of the current calibration curve (when monthly
calibration is used) and are not used for monitoring long term variation. Quality Controls for this
purpose.
3 SD is the limit for accepting results. When results are outside the outer limit it is still possible
to run a new Calibration Curve to see if a systematic shift has occurred. If Calibration Curve run
later during the day or the day after is compensating for the shift the Method is considered as ok
and results can be accepted.
How to enter the QC information in the IDM is described in the Operation/Quality Control
Management chapter.
Quality Control Charts

The IDM software uses control charts to monitor internal quality control. There are two ways to
define the limits that are illustrated as lines in the Quality Control chart.
If... then...
a new quality control sample lot is used no expected values obtained in the laboratory
are available. In this case the ranges given in
the package insert may be used.
a minimum of 20 observations have been the laboratory mean and SD should be used for
collected the new control limits.
Example of control charts created using the IDM software.
The control charts created in the software can be plotted by defining a start date and a finish date.
All observations between these dates will then be displayed.
External Quality Assessment
Quality Club
Control charts give information about the precision and the pattern of variation within a laboratory,
but they give little information about trueness and no information about the performance of a
laboratory in relation to other laboratories. To obtain such information, laboratories using the
same type of testing need to assay the same samples.
If the internal quality control shows low variation of results on a constant level, this means the
analytical procedure is stable. By comparing the concentration levels obtained in the external
quality assessment program, it is possible to judge the accuracy of the measurements in the
laboratory.
Example of the difference between Internal
quality control and External quality assessment.
Once low variation and good accuracy has been established for the analytical procedure, it is
essential to continuously monitor the performance using internal and external quality control
programs in order to maintain high quality results.
Quality Club is an external proficiency testing program for laboratories using ImmunoCAP and
EliA for in vitro allergy, autoimmunity and inflammatory testing.
Participation in the external quality assessment programs of Quality Club gives the laboratory
management and staff a possibility to compare their in vitro test results with results obtained in
other laboratories worldwide. As there are no established true values for in vitro allergy,
autoimmunity and inflammatory testing, the common mean values obtained in Quality Club
programs are considered to be the best estimates of true values. Thus, participation in Quality
Club is a tool to monitor the accuracy of the laboratory measurement process for in vitro allergy,
autoimmune and inflammatory testing.
Programs in Quality Club

The programs for specific IgE, Total IgE, ECP, EliA IgG and EliA IgA are similar. Every fourth
month a kit with samples is distributed to the members. Included in the kit are also Directions
for Use.
Each month during the 4-month cycle the pre-requested samples are analyzed. The samples
should be treated as ordinary patient samples. Thus they should be put randomly in the assay
and analyzed according to the normal routine.
The results are reported on an electronic Result Card present on the Thermo Fisher Scientific
website at the end of the month for statistical evaluation.
How to enter Quality Club samples in Phadia IDM is described in the Operation/Quality Control
Management chapter.
Monthly Report
Specific IgE, EliA IgG and EliA IgA results for each of the three allergens/antigens requested
per month are put together by use of established statistical methods. The results are presented in
histograms with a class interval depending on the concentration level (see histogram below).
Results outside 3.5 SD are summarized in white bars. Results for total IgE and ECP for each
of the two samples are put together, using the same statistical methods as for specific IgE. The
results are presented in a format similar to specific IgE in order to facilitate the interpretation.
The results from the individual laboratory are given as concentrations, % deviation from common
means and deviation scores. In the histograms, the bars containing these results are black.
The use of deviation score makes it possible to compare different allergens and different
concentration levels in spite of only single determinations. In order to be able to compare
determinations from many allergens on different concentration levels, or many samples on
different concentration levels in the Summary Report (see below), these determinations must be
measured on a scale with the standard deviation between laboratories as unit of measure. Although
the standard deviations will differ between allergens and/or concentration levels, this method
provides a standardized measure of the deviation of a laboratory in relation to the performance
of the group of laboratories.
The deviation score is calculated as shown below:
Common mean 26.02
Standard deviation 2.73
Lab result 28.70
Deviation score (28.70 - 26.02)/2.73 = 0.98

Example of a Monthly Report for Specific IgE. Presented
results are from laboratories using Phadia 100.
Interpretation of Monthly Reports

Deviations from the mean up to 2SD indicate a well-functioning process. One single
determination outside this range need not cause any alarm. However, the use of the correct
reagents and ImmunoCAP within expiration dates should be checked in connection with the
routine check of the analytical run comprising calibration curve, range of patient samples and
quality controls. If two or all three results are outside the range, a procedure and instrument
check-up is recommended.
Summary Report
Summary Reports are sent out after each four-month cycle covering the last three cycles (one
year). The Summary Reports thus reflect the long-term method performance in the laboratory.
For each laboratory, the report is based on at most 36 (12 x 3) observations for Specific IgE,
EliA IgG, EliA IgA and 24 (12 x 2) observations for Total IgE and ECP.
Interpretation of Summary Reports

For each laboratory, mean and standard deviation of deviation scores are calculated. The first
two graphs in the Summary Report show the distribution of these data for all participating
laboratories. The bars including the results from the individual laboratory are black. Exact figures
are given below the graphs or in the left margin. Values outside 1 for mean of deviation score
and >1.4 for standard deviation of deviation scores are collected in the white bars.
Example of a summary report for Specific IgE. The presented
results are from laboratories using Phadia 100.
A small standard deviation (<1.4) and a mean close to zero (within 0.7) indicate a
well-functioning analytical process.
A small standard deviation (<1.4) and a mean far from zero (> 0.7) indicate a constant bias.
A large standard deviation, regardless of mean, indicates an unstable process ("high variation").
Note:
The results for the mean and standard deviation can be outside the above recommended ranges
due to a few extreme results during the latest year. This does not necessarily have to influence
the general impression of the long-term performance. These extreme results will not be included
in the next Summary Report.
To observe if deviations are related to the concentration level, the deviation score is plotted versus
the common mean concentration obtained by the laboratories during the last three cycles. The
observations from the last cycle are denoted with black dots. The range of the graph is between
-4 and +4. Deviation scores with results outside these limits are not included, but are given in
the margin.
Example of deviation score vs mean concentration
The deviation score is also plotted versus time. This can be done for a single allergen or for all
measured samples. These graphs make it possible to discover trends and/or shifts with time.
Example of allergen d1, deviation score vs time.

Example of a time trend plot.
The different graphs give a general view of the performance. The pattern of the dots, representing
observations from the last cycle in the concentration level graph, makes it possible to detect
changes in performance from the previous cycle.
Expected Results
All in vitro allergy, autoimmunity and inflammatory testing are immunodiagnostic procedures.
For such procedures it is not possible to obtain the %CV in the same range as for "classical"
clinical chemistry analytes like sodium, glucose etc, in internal quality control and external quality
assessment programs. For most immunodiagnostic procedures, such programs normally give CV
in magnitude of 5 - 10%.
For IgE, the WHO international reference preparation is the basis for calibrations. Thus, total
IgE tests are comparable to other immunodiagnostic tests from an external quality assessment
program point of view.
For specific IgE, the situation is somewhat different. The allergen preparations used are of
biological origin with no international reference preparations available. They consist of a complex
mixture of many different protein components. As an example, peanut allergen consists of 25
different major and minor allergenic components. There are thus many possibilities for
batch-to-batch variation of the allergen source material (natural variation).
These complex mixtures must be handled in a way to allow reproducibility throughout the whole
production process in order to secure high quality test results.
Results from laboratories participating in the Quality Club program in more than 30 different
countries and using different production lots of ImmunoCAP Allergen demonstrate performance
standards with coefficients of variation that are only slightly higher than for other
immunodiagnostic procedures.
External quality assessment programs involving different specific IgE methods show ImmunoCAP
to be the most robust, user-independent and reproducible specific IgE test on the market.
Quality Costs
It is important to understand that the concept of quality costs is broader than the cost of quality
control. Without this basic understanding, only the costs associated with day-to-day quality
control and external quality assessment will be apprehended. (Elin RJ, Elements of cost
management for quality assurance.)
College of American Pathologists (1980;34:182-3,194) has described the quality costs in clinical
laboratories as a concept consisting of two different components.
Costs of securing good quality:
Prevention costs: "expenses for developing, using and improving a planned quality control
program". Examples are training, calibration and maintenance.
Appraisal costs: "expenses for the operation and maintenance of an internal (intra-laboratory)
quality assurance program and an external (inter-laboratory) quality assurance program".
Examples are inspection and quality control.
Costs of inadequate quality:
Internal failure costs: "expenses for reworking and/or discarding an entire batch of specimen
results or an individual specimen due to some element of improper processing that leads to
an erroneous result". Examples are repeated runs and repeated work efforts.
External failure costs: "expenses for the investigation of all inquiries by the physician or patient
consumer as a result of the inability of the laboratory result (or lack of result) to help solve
the patient care problem". Examples are complaints, service and repeat requests.
Keep in mind that without proper quality efforts the laboratory will have higher quality costs and
products and services of lower quality. With a solid quality assurance program implemented in
the laboratory, the costs of inadequate quality will decrease and the quality of products and
services will increase.
Maintenance
Maintenance has to be performed regularly to keep the instrument in good condition and to secure
the instrument performance. Negligence of maintenance leads to processing errors as well as
assay result errors.
The following symptoms could be caused by insufficient maintenance:

Visual impression, i.e. dark tubing, liquid containers and buffer tanks
Wash Solution looks cloudy and is smelling badly
Processing errors related to IRW drainage, blocked tubings/filters/valves, clogged wash rake,
retries at level detection
Typical result problems related to 'dirty' instruments:
Erroneous results due to blockage in liquid system.
Higher variation for CAL
Increased backgrounds, i.e. results for negative controls
Increased Blank results
Low RU messages
To avoid errors, perform maintenance regularly according to this chapter. If the maintenance has
not been performed according to the schedule a warning will be presented when the instrument
starts up.
Note:
The instrument should never be left with Washing Solution remaining in the liquid system
overnight.
This chapter describes how to maintain the Phadia 250 instrument. The following maintenance
is required:
Daily Maintenance
Weekly Maintenance
Monthly Maintenance
Unscheduled Maintenance
Daily Maintenance
In Daily Maintenance, the Wash is replaced with Rinse in the liquid system in order to prevent
growth that could cause blockage and/or carry over.
Daily Maintenance includes following actions:
Daily Rinse
Surface cleaning
Reboot of the instrument
Daily Rinse
Daily Rinse has to be done immediately after each run. Daily Rinse shall be performed by selecting
Daily rinse on the Assay Processing/ End Assay screen.
After all tests have been processed, the instrument will automatically continue with rinsing of
the liquid system.
The Daily Rinse procedure takes approximately 38 minutes and will consume 2.5 litres of Rinse
Solution from the Rinse Bottle and 0.1 litres of Washing Solution from the Wash bottle.
For special needs, Daily Rinse can also be started manually from the Utilities/User Maintenance
screen and will then consume 3.3 litres of Rinse Solution from the Rinse Bottle and 0.2 litres of
Washing Solution from the Wash bottle.
Note: If the time since the last ImmunoCAP/EliA Well in the reaction wheels was ejected exceeds
the default value 180 minutes, and no rinse has been performed, a rinse is automatically started.
A warning message is displayed: Assay run was finished automatically due to inactivity to secure
instrument function.
Note: Do not prime the instrument with wash after finished Daily maintenance. The instrument
shall be left rinsed until next assay starts.
Surface Cleaning
Clean the outer surface with a dry cloth if spillage has occurred.
Reboot of the Instrument

It is recommended to reboot the instrument each day. The shutdown of the instrument is normally
included at the end of the Daily Rinse procedure (Parameter Setting).
Weekly Maintenance
The purpose of Weekly Maintenance is to substitute Rinse Solution for all liquids in the Washing
Solution and Rinse Solution system, and to clean the Wash, Rinse and Waste bottles in order to
prevent growth that could cause blockage and carry-over. Weekly Rinse shall also be performed
if a breakdown of the instrument occurs, and the problem is solved within same day.
The Weekly Maintenance shall be performed at the end of the week or before a longer break and
includes following actions:
Weekly Rinse
Cleaning of Wash, Rinse and Waste Bottles including connectors
Surface Cleaning
After finished Weekly Maintenance, the instrument shall be left clean with empty bottles until
next assay starts.
When Weekly Maintenance is performed the Daily Rinse is not needed that day.
Note: If more than 10 days have passed since last Weekly Maintenance, it will not be possible
to start an assay until a Weekly Maintenance is performed.
Weekly Rinse
Weekly Rinse is started from the Utilities \ User Maintenance window and can be performed
as ordinary or extended procedure. The extended procedure is default whenever any IgG, IgA
or IgM method is set as active in IDM in order to prevent carry over.
There is also an option to shut down the instrument automatically after the final rinse has been
performed.
1. Disconnect the tubing from the Wash and Rinse bottles.

2. Empty and rinse the Wash and Rinse bottles, including connectors.
3. Empty the Waste bottle.
Note: Do not unscrew the cap from the bottles if the tubing is still connected. This can cause
problems with insufficient distribution of rinse solution due to twisted tubing.
4. Fill the Rinse bottle with a minimum of 3.7 litre Rinse solution.
5. Fill the Wash bottle with a minimum of 1.1 litre Rinse solution.
6. Load and connect the bottles on the instrument.
7. If extended procedure is to be performed, prepare also a sample tube with at least 5 ml 5%
Sodium Hypochlorite. Load a sample rack in the leftmost position with the sample tube placed
in position 1. This tube will be used for extra cleaning of right Pipette tip and Overflow Cell.
8. In Weekly Rinse press START.
Essential parts of the system are rinsed. The Weekly Rinse takes about 45 minutes for the ordinary
procedure and 48 minutes for the extended procedure.
Note:
Do not prime the instrument with wash after finished Weekly Maintenance. The instrument shall
be left rinsed until next assay starts.
Note:
When experiencing problem with Carry Over also perform the following:
Clean right arm pipette with 70% ethanol (or isopropanol) on a lint-free cloth or a disposable
pre-soaked alcohol wipe before run.
Clean overflow cell with alcohol-soaked cotton-bud.
Cleaning of Wash, Rinse and Waste Bottles

When the procedure is completed, disconnect the tubing and empty and rinse the Wash and Rinse
bottles including connectors using Rinse Solution. Empty and rinse containers for preparation
of Washing Solution using Rinse Solution. Empty and rinse the Waste bottle using tap water.
Empty the Solid Waste Container. If extended procedure has been performed, unload the sample
tube with Sodium Hypochlorite.
Surface Cleaning
1. Make sure the System Power is off.
2. Wipe of the pipette tip and the upper inner part of the right Overflow Cell with a lent free
tissue moistened with Ethanol (70%) or Isopropanol (70%). Start the cleaning of the pipette
tip from the upper part towards the lower.
3. Clean the outer surfaces including Touch Screen on the instrument, if spillage has occurred.

It is recommended to reboot the instrument each day. The shut down of the instrument can be
included in Weekly Rinse procedure.
Monthly Maintenance
The purpose of the Monthly Maintenance is to clean all essential parts involved in liquid system
on the instrument in order to prevent growth that could cause blockage, or carry-over, and
transmission of infections. Monthly Maintenance can also be performed when experiencing
precision or carry over problems. Monthly Maintenance shall also be performed if a breakdown
of the instrument occurs and the problem cannot be solved within same day.
When Monthly Maintenance is performed, the Weekly Maintenance is not needed that week and
Daily Rinse is not needed that day, except if EliA technology is to be run on the instrument (see
further Additional actions after Sodium Hypochlorite).
The Monthly Maintenance shall be performed once a month, preferably at the end of the week
or before a longer break, and includes following actions:
Monthly Maintenance Procedure
Additional actions after using Sodium Hypochlorite as Cleaning Solution
Cleaning of Wash, Rinse and Waste bottles including connectors
Lubrication of O-rings
Cleaning of ImmunoCAP Transfer and Ejection Tool
Cleaning of Sample Racks
Surface Cleaning
The following cleaning solutions are used in the Monthly Maintenance procedure:
Maintenance solution, prepared according to the DfU (recommended).
Sodium Hypochlorite, diluted to 1% solution (3-4 times/year if running EliA).
Note:
If Sodium Hypochlorite has been used as Cleaning Solution, some additional actions are needed
before starting next assay.
Note:
If extended procedure is to be performed, you need also 5 ml 5% Sodium Hypochlorite.
After the Monthly Maintenance is finished, the instrument shall be left clean with empty bottles
until next assay is started.
Note: If more than 40 days have passed since last Monthly Maintenance, it will not be possible
to start an assay until a Monthly Maintenance is performed.
Monthly Maintenance Procedure

Monthly Maintenance is started from the Utilities \ User Maintenance window and can be
performed as an ordinary or an extended procedure. The extended procedure is default whenever
any IgG, IgA or IgM method is set as active in IDM in order to prevent from carry over.
There is also an option to shut down the instrument automatically after the final rinse has been
performed.
When handling Cleaning Solution (Maintenance Solution or 1% Sodium Hypochlorite) protective
gloves should be used.
1. Before starting the cleaning procedure, clean and rinse Wash, Rinse and Waste bottles and
tubing with connectors.
Note: Do not unscrew the cap from the bottles if the tubing is still connected. This can cause
problems with insufficient distribution of rinse solution due to twisted tubing.
2. Fill the Rinse bottle with a minimum of 2.3 litre Cleaning solution.
3. Fill the Wash bottle with a minimum of 1.3 litre Cleaning solution.
4. Load and connect the bottles on the instrument.
5. If extended procedure is to be performed, prepare also a sample tube with at least 5 ml 5%
Sodium Hypochlorite. Load a sample rack in the leftmost position with the sample tube placed
in position 1. This tube will be used for extra cleaning of right Pipette tip and Overflow Cell.
6. In Monthly Maintenance press START.
The liquid system in the instrument is now primed with Cleaning Solution which takes about
36 minutes. After priming, the incubation is started. The incubation time is 15 minutes. During
this time the Wash and Rinse bottles should be cleaned thoroughly.
7. Rinse both bottles five times with tap water and once with purified water. Tubing and quick
connectors must also be thoroughly rinsed. When Wash and Rinse bottles have been filled
with Rinse solution (3.5 + 3.5 litres) it is time to press CONTINUE.
The remaining rinse time is approximately 73 minutes for the ordinary procedure and 80
minutes for the extended procedure.
Note:
Do not prime the instrument with wash after finished Monthly Maintenance. The instrument shall
be left rinsed until next assay starts.
Note:
When experiencing problem with Carry Over also perform the following:
Clean right arm pipette with 70% ethanol (or isopropanol) on a lint-free cloth or a disposable
pre-soaked alcohol wipe before run.
Clean overflow cell with alcohol-soaked cotton-bud.
Additional actions after using Sodium Hypochlorite as

Cleaning Solution
As even very small residuals of Sodium Hypochlorite can affect assay results following additional
actions shall be done:
Do not start assay within 60 h (e.g. from Friday to Monday) after finished Monthly Maintenance.
EliA Technology
Perform in addition two Daily Rinse and one Weekly Rinse. Do not start assay within 60 h (e.g.
from Friday to Monday) after finished Monthly Maintenance.
Cleaning of Wash, Rinse and Waste bottles

1. When the procedure is completed, disconnect the tubing and empty and rinse the Wash, Rinse
and Waste bottles including connectors.
2. Empty the Solid Waste container.
3. If extended procedure has been performed, unload the sample tube with Sodium Hypochlorite.
Lubrication of O-rings
The lubrication of O-rings on the bottle connections is important in order to secure the connection
and make it smooth.
1. Lubricate the O-rings on the Wash, Rinse and Waste bottle connectors with Vacuum Grease
(12-3505-12). Use only a small amount of grease to avoid the lubricant from entering the
bottles.
2. Connect the tubing and load the bottles into the shelf.
Clean ImmunoCAP Transfer and Ejection Tool

1. Wipe of the ImmunoCAP Transfer Tool with a dampened cloth.
2. To dissolve possible stop solution crystals, soak the ImmunoCAP ejection Tool in a small cup
of hot water and wipe of with a dampened lint-free cloth.
Clean Sample Racks

1. Check that all racks are OK and that they are not broken. Check that all tube holders that
centre the tubes are OK and that the tubes stand firmly straight up. A broken rack shall never
be used on the instrument as this can cause incorrect pipetting from sample tube.
2. Clean the racks with Ethanol (70%) or Isopropanol (70%).
Surface Cleaning
1. Make sure the System Power is off.
2. Wipe of the pipette tip and the upper inner part of the right Overflow Cell with a lent free
tissue moistened with Ethanol (70%) or Isopropanol (70%). Start the cleaning of the pipette
tip from the upper part towards the lower.
3. Clean the outer surfaces including shelf and Touch Screen on the instrument.
It is recommended to reboot the instrument each day. The shut down of the instrument can be
included in Monthly Maintenance procedure.
Unscheduled Maintenance
Test Functions
Unscheduled Maintenance consists primarily of test-functions on the Utilities/User Maintenance
and Super User Maintenance screens. The functions are used only for troubleshooting.
The following functions are available on the Utilities/User Maintenance screen:
Prime
Blank Measurement
Initialize
The following functions are available on the Utilities/Super User Maintenance screen (you
need a password to access these functions):
Initialize
FluoroC Measurement
Functional Test (only for service purpose)
Washing (only for service purpose)
Verify Carrier Storage
Request result to diskette (only for service purpose)
Eject ImmunoCAP/EliA well
Carrier Transfer between Storage Trays
Sensor Setting (only for service purpose)
Prime
This function is started in User Maintenance and is used only for trouble shooting. The same
procedure is automatically carried out when an assay run is started.
1. Load new bottles with fresh Wash Solution and Rinse Solution and ensure that Waste bottle
is connected.
2. Press START.
The Liquid System is filled with new fresh solutions.
Prime procedure takes approximately 9 minutes and consumes 0.8 litres Rinse from Rinse Bottle
and 0.8 litres Wash from Wash bottle.
Note:
The instrument should never be left with Washing Solution remaining in the liquid system.
Perform a Daily Rinse or Weekly Rinse as soon as possible.
Blank Measurement
This function is started in User Maintenance and is measuring Rinse and Reagent Blank. The
same procedure is automatically carried out when an assay run is started.
1. Make sure that Rinse Solution, Development Solution and Stop Solution bottles are loaded
and that Waste bottle is connected.
2. Select Technology (ImmunoCAP or EliA Well) and press START.
The blank measurement starts and the results are presented when the Blank Measurement is
completed.
Initialize
This function is started in User Maintenance or Super User Maintenance and is checking all
mechanical movements. The same procedure is automatically carried out when an assay run is
started.
This procedure can be used when you need to take off the upper lid and want to move away the
robotic arms.
The procedure takes approximately 1 minute.
FluoroC Measurement
This function is started in Super User Maintenance and is checking the performance of the
Fluorometer.
1. Make sure that Rinse Solution and Stop Solution bottle are loaded and that Waste bottle is
connected.
2. Read the Barcode on the FluoroC vial label to establish Target value.
3. Press START.
The FluoroC measurement starts and the results are presented when the measurement is completed.
If the results are Not Ok it might be necessary to calibrate the Fluorometer. Contact your local
Phadia representative for service.
Wash Volume Check

Correct wash volume in the washing steps is important for reliable results, especially for EliA
tests. Wash Volume Check verifies that the wash volume dispensed by the washing stations is
within acceptable limits.
Wash Volume Check can be performed either automatically at assay start, if the corresponding
system parameter is set to ON, or by selecting the volume check in Super User Maintenance
as described below.
Perform Wash Volume Check

Follow the instruction to perform Wash Volume Check. Super User access is required.
1. Make sure that at least 20 Xummy wells are loaded in the Carrier storage.
2. In the Main screen, press UTILITIES.
3. In the Utilities screen, press SUPER USER MAINTENANCE.
4. In the SUPER USER MAINTENANCE screen, press Functional test.
Result: The FUNCTIONAL TEST screen opens.
5. In the Functional test screen, press WASH VOLUME CHECK.
Result: Wash Volume Check screen opens.
6. In the Wash Volume Check screen, press START.

Result: The check starts.
7. Read the result in the Wash Volume Check screen after Wash Volume Check completion.
If Wash Volume Check is OK, continue as desired.
If Wash Volume Check is Not OK, follow the instructions in the section below.
If Wash Volume Check is Not OK

If the Wash Volume Check result has failed, contact your local Phadia representative for assistance.
Note: Running an EliA assay after failed Wash Volume Check is not recommended. The test
result may be affected.
To perform an assay run despite of failed Wash Volume Check, make first sure that other quality
parameters are within acceptable limits.
Verify Carrier Storage

This function is started in Super User Maintenance and is checking that the content of the Carrier
Storage is according to the ImmunoCAP Carrier Information list.
The procedure takes approximately 25 minutes.
Press START.
The verification of all positions in the Carrier Storage will start.
All carrier positions with errors will be marked and are then possible to remove from the Storage.
Eject ImmunoCAP / EliA Well

This function is started in Super User Maintenance and makes it possible to remove all
ImmunoCAP / EliA Well from the reaction wheels.
This function can be used when the instrument has been stopped unexpectedly in the middle of
a process or the assay has been aborted by the operator.
Press START
The ejection of all ImmunoCAP / EliA Well from the reaction wheels will start. The process
takes approximately 25 minutes.
After the ejection a Weekly Rinse has to be performed as soon as possible.
Note:
The instrument should never be left with Washing Solution remaining in the liquid system.
Carrier Transfer between Storage Trays

This function is started in Super User Maintenance and allow transfer of all carriers from one
Storage tray to an empty Storage tray.
This procedure can be used when you want to check the carrier holders in a Storage tray or clean
the Storage tray that has been used.
1. In Transfer ImmunoCAP Carrier between Storage Trays first select the Tray you want to
transfer the carriers from.
2. Then select the Tray you want to transfer the carriers to. ID for chosen Trays will be shown
on display.
3. Press START.
The transfer of the carriers between Storage Trays will start.
Troubleshooting
How to Avoid Problems

In order to avoid problems and error messages with Phadia 250, the user needs to have knowledge
regarding the critical steps in handling the instruments. It is critical to understand the importance
of maintenance and the importance of working according to the instructions for users in this
manual.
This chapter describes how to avoid problems and how to handle existing problems.
Placement/environment
Do not place the instrument in direct sunlight or draft.
Note: Variances in the humidity and the temperature of the laboratory can affect the assay results.
In order to establish a homogeneous environment during the assay, secure that the air conditioner
in the laboratory is switched on before starting an assay. It is recommended to have the air
conditioner on throughout the whole assay, in order to avoid variations in the environmental
temperature and humidity.
Reagent handling
For on-board stability see the Instrument Description chapter in this manual.
ImmunoCAP Conjugate
The IgG and IgA methods are more sensitive to contamination of the conjugate since IgG and
IgA are present in much higher concentrations in human blood. To avoid contamination, do not
touch the threads of the conjugate bottles. Change gloves before and after handling the conjugates.
Make sure that there are no bubbles in the conjugate bottle, before loading it into the instrument.
The presence of bubbles in the bottle may lead to incorrect level detection resulting in incorrect
results.
It is not recommended to pool the conjugates!
Note: IgA is not an available method on the Phadia 250, Phadia 2500 and Phadia 5000.
EliA Conjugate
The IgG and IgA methods are more sensitive to contamination of the conjugate since IgG and
IgA are present in much higher concentrations in human blood. To avoid contamination, do not
touch the threads of the conjugate bottles. Change gloves before and after handling the conjugates.
Make sure that there are no bubbles in the conjugate bottle, before loading it into the instrument.
The presence of bubbles in the bottle may lead to incorrect level detection resulting in incorrect
results.
It is not recommended to pool the conjugates!
EliA Conjugate is for single use. The stability of the conjugate is reduced over time and also with
increasing sample dilution. However, EliA IgA, EliA IgG and EliA IgM Conjugate 200 can be
used the next calendar day if less than 50 samples have been run the first day and the bottle is
recapped and stored at 2-8 C over night. EliA IgA, EliA IgG and EliA IgM Conjugate 50 can
be used the next calendar day if less than 10 samples have been run the first day and the bottle
is recapped and stored at 2-8 C over night.
Make sure that there are no bubbles in the Development Bottle, before loading it into the
instrument. The presence of bubbles in the bottle may lead to incorrect level detection resulting
in incorrect results.
If there is a problem with the results (low values) make sure that there are no crystals in the
Development Bottle. During storage in the refrigerator crystals may precipitate, leading to
concentration problems.
CC/Calibrators
When reloading an already used Curve Control Strip which has been removed from the Strip
Rack, the used wells must be marked as used. Marking of used wells is done manually on the
instrument software screen, see the Load CC/Calibrators section in the Operation chapter.
Remember to gently mix the strips before use if the strips have been standing for a long time.
Carriers
If there is a problem with dispensing of the ImmunoCAP/EliA Well Carriers, try shaking the
carriers before loading them into the instrument.
EliA Wells are sensitive to moisture/humidity and should therefore be stored in the refrigerator
in an aluminum foil bag when not stored in the instrument.
Washing Solution
The quality of the water is highly important. Make sure to use Purified Water for preparation of
the Washing Solution, in order to avoid growth in the instrument which can lead to instrument
malfunction. Always perform Weekly Maintenance on a weekly basis. After finished Weekly
Maintenance the instrument shall be left rinsed with an empty Wash Tank until starting the next
assay.
Bad smell from and poor visibility in the Washing Solution is an indication of bacterial growth.
Clean the tank thoroughly according to the description in the Maintenance chapter of this manual.
Specification for Purified Water
The specification for Purified Water according to Pharmacopeia guidelines is:
Parameter Purified Water Specification

Conductivity ( S/cm at 20 C) < 4.3
TOC (ppb C) < 500
Nitrates (ppb) < 200
Heavy metals (as ppm Pb) < 0.1
Bacteria (CFU/mL) < 100
Evaporation
Good Laboratory Practice (GLP) dictates that every precaution must be taken to avoid evaporation
and contamination in order to guarantee reliable results. Try to minimize the time period from
uncapping the reagents until loading them into the instrument.
Note: The Quality Control samples of the ImmunoCAP methods have to be recapped and removed
from the instrument as soon as the Rack is unlocked. The EliA Quality Control samples are for
single use and should be discarded after the run.
Pooling
Note: It is NOT recommended to pool any reagents.
Securing reagent volumes

Use the Load List to verify that the needed volumes of the reagents are available.
Never use reagents for more determinations than recommended.
Sample Handling
Only the tubes types that are defined in the instrument should be used. To view the tube type,
see the Request List window. Ensure that the tube parameters are properly defined for used
sample tube types.
In order to ensure proper sample volume pipetted, it is always important to visually check the
samples before loading them into the instruments e.g. check that the volume is enough for
requested tests, including necessary dead volume.
It is important to pop air bubbles and remove any fibrin clots from the sample tubes. Remaining
foam or air bubbles might be aspirated instead of sample.
Before loading sample tubes into racks ensure that all racks are OK and that they are not broken.
A broken rack shall never be used on the instrument; this can cause incorrect pipetting from
sample tube.
Sample tubes must be placed in an upright position at the bottom of the Sample Racks. Any
misalignment of the sample tube might cause the sample not to be properly aspirated.
is solved.
When the rack is inside the sample loading area during process. It is strictly forbidden to lift,
or remove, tubes from the rack. Tubes shall only be handled outside the instrument, i.e. when
the rack is not loaded into the instrument.
The importance of maintenance

Poor maintenance may lead to processing errors related to drainage of the Immuno Reaction
Wheel (IRW), blocked tubing/filters/valves and clogged Wash Rakes. To avoid errors, perform
maintenance regularly according to the instructions described in the Maintenance chapter of
this manual.
Most common issues

Mix up of samples (operator handling)
Missed pipettings, caused by:
- Level detection problems
- Incorrect sample tube settings
- Wrong tubes used, gel tubes (sample volume is not enough)
- Damaged Sample Racks
Clogged samples, which can lead to pipetting errors
Problems with the sample wash (EliA)
High blanks
Fluorometers liquid system problem
Correct sample handling and a well maintained instrument can prevent a lot of the issues above.
The importance of following the instructions in the

manual
Follow the instructions in the manual in order to avoid introducing errors in the sample handling
procedures, maintenance procedures etc.
If problems appear go through the described procedures in the Manual, e.g Operation and
Maintenance chapters, to make sure that the procedures in the lab are in accordance with the
recommendations.
Deviation
QC
QC out of limit is usually a consequence of:
Too narrow limits
Air bubbles
Variation in environmental conditions
Too low/ high Calibrator run, recalibration needed
ImmunoCAP lot change
Fluorometer
Incorrect sample wash volumes (most critical for EliA)
To avoid getting QCs out of limit consider the following:
It is important to set the relevant QC limits in order to avoid incorrectly rejected runs.
Always cap the QC bottles in between runs to avoid evaporation of the QC leading to incorrect
results.
Cal/CC
Rejected Calibration Curves or Curve Controls are usually a consequence of:
Poorly mixed strips.
Contamination directly to the strip either from a sample or from skin contact. Do not touch
the foil (this is most critical for IgA and IgG products). Change gloves when handling the
strips.
Sample and Conjugate wash problems. (EliA)
Variation in the environmental conditions.
APD calibrations.
Fluorometer.
IDM Messages
IDM Messages can be generated both from Windows and IDM, and will be displayed in a similar
way. The text in the messages is well explained, and will give the operator directives to continue.
If an Error message will re-occur repeatedly contact your local Phadia representative.
Some of the messages will be logged in the System Log, and is accessible if you have logged in
as a Superuser. Some messages will also cause the SYSTEM button to flash, in order to have the
attention of the operator.
The windows below will pop up when calibrator errors or curve control errors are detected during
a run.
Calibration Curve Not OK
This window is displayed when the RU values for more than 3 replicates, or both replicates of
the lowest calibrator, are out of range. The values for both replicates of the lowest calibrator
point must be bad (for EliA the second lowest calibrator). The dispensing of ImmunoCAP/EliA
Well will be stopped while this message is displayed, but the processing of tests already started
will continue. No concentrations will be calculated.
Window Items
The Calibration Curve Not OK window provides the following features.
The recommended selection is placed first.
Message Field
Displays the error message and additional information.
Method Field
Displays the method used for processing the calibration curve.
Instrument Field
Displays the identity of the instrument generating the error message.
Calibrators List
Identity Column Displays the identity of the calibrator.
Measured Column Displays the time when the calibrator was processed.
Status Column Displays the status for the calibrator (OK, Not OK).
Resp Column Displays the response value for the calibrator.
Calc Column Displays the calculated concentration for the calibrator.
Conc Column Displays the known concentration for the calibrator.
Calibration Curve Graph

Displays the RU values for the calibrators included in the calibration curve. Bad replicates are
represented by a red 'x'.
Process new calibration curve now Option Button
Select this option button to process a new calibration curve.
Phadia 250 and Phadia 1000 with a strip loaded:
The processing of a new calibration curve is started immediately.
Phadia 250 without a strip loaded:
The message 'Could not start calibrators' is displayed. A new calibrator curve must be run in
next analytical run.
The operator must load a new calibrator strip, and the processing of a new calibrator curve is
started.
The dispensing of ImmunoCAP/EliA Well will resume when this option is selected. If the new
curve is ok, concentrations for current tests will be calculated using the new curve.
Select calibration curve from log Option Button
Select this option button to select a previously processed calibration curve from the log. Dispensing
of ImmunoCAP/EliA Well will resume when this option is selected. Concentrations for current
tests will be calculated using the selected curve.
This option is recommended to use to quickly check and verify that the samples and quality
controls would be good in this run by calculation with another stored calibrator curve in order
to later process a new calibration curve for evaluation. This is specially useful when running
Phadia 250 without a strip loaded.
Skip calculation, and continue Option Button
Select this option button to continue the processing. No concentrations will be calculated. The
dispensing of ImmunoCAP/EliA Well will resume when this option is selected.
This option shall be selected when a new calibration curve is not possible to process and it is
obvious that it is only a problem with the results of the Calibration Curve. A new calibration
curve has to be run later to be used for evaluation. With this selection it is good to add additional
QC in the run to better confirm the quality in results.
Skip calculation, and new tests will not be started Option Button
Select this option button to continue the processing of tests currently in the process. No
concentrations will be calculated. The dispensing of ImmunoCAP/EliA Well will not resume,
and new tests will not be started.
This option shall be selected when a new calibration curve is not possible to process and there
is a risk that there is a problem with the results in general. A new calibration curve can be run
later for evaluation and the quality of the run can then be judged by checking the QC results.
Select Button
Click this button to execute the option selected.
Minimize Button
Click this button to minimize the window without making a selection now. The window will
reopen each time you click the F3 - RESULT button or press F3 on your keyboard.
Calibration Curve Partly Not OK

This window is displayed when the RU values for 2-3 replicates are out of range. The RU value
for at least one replicate of the lowest calibrator point must be OK (for EliA the second lowest
calibrator point). The run will proceed normally, i.e. concentrations are calculated and the
dispensing of ImmunoCAP/EliA Well will continue. You will be informed to process a new
calibration curve with the next assay run.
Note:
This window is for information only, and no action needs to be taken. Click the OK button to
close the window. For more information about the elements of this window, see the Calibration
Curve Not OK window above.
Curve Controls Not OK
This window is displayed when the RU value for one curve control replicate is High or Low, or
when the values for the replicates are a combination of High* and Low*. No concentrations will
be calculated for measured tests. The dispensing of new tests will continue.
Window Items
The Curve Controls Not OK window provides the following features.
Message Field
Displays the error message and additional information.
Method Field
Displays the method used for processing the curve controls.
Instrument Field
Displays the identity of the instrument generating the error message.
Curve Controls List
Identity Column Displays the identity of the curve control.
Measured Column Displays the time when the curve control was processed.
Status Column Displays the status for the calibrator (High, High*, OK, Low*,
Low).
Resp Column Displays the response value for the curve control.
Conc Column Displays the calculated concentration for the curve control.
Expected Column Displays the expected concentration for the curve control.

Displays the RU values for the calibrators used for calculation.
The message 'Could not start calibrators' is displayed. A new calibrator curve must be run in
started.
If the new curve is accepted, concentrations for current tests will be calculated.
dispensing of ImmunoCAP/EliA Well will resume when this option is selected.
This option shall be selected when a new calibration curve is not possible to process and it is
obvious that it is only a problem with the results of the Calibration Curve. A new calibration
is a risk that there is a problem with the results in general. A new calibration curve can be run
later for evaluation and the quality of the run can than be judged by checking the QC results.
Select Button
Minimize Button
Curve Controls Partly Not OK

This window is displayed when the RU value for one curve control replicate is High* or Low*,
or the value for both replicates is either High* or Low* (the same status for both replicates).
Concentrations for tests in this run will be calculated. Unless new curve controls are processed
in this run and are OK, you will have to process a new calibration curve in next run.
Note:
This window is similar to the Curve Controls Not OK window. For more information about
the elements of this window, see the Curve Controls Not OK window above.
Window Items
The Curve Controls Partly Not OK window provides the following features.
Process new curve controls now Option Button
Select this option button to process a new set of curve controls.
The processing of a new curve control is started immediately.
The message 'Could not start calibrators' is displayed. A new curve control must be run in
The operator must load a new calibrator strip, and the processing of a new curve control is
started.
If the concentration for the curve controls are OK, concentrations for current tests will be calculated
and the dispensing of ImmunoCAP/EliA Well will resume.
Process a new calibration curve in next run Option Button
Select this option button to process a new calibration curve in the next run.
Select Button
Minimize Button
Re-measured Curve Controls Not OK

This window is displayed when the RU values for the re-processed curve controls are not perfect.
No concentrations will be calculated for measured tests. The dispensing of new tests will continue.
Note:
This window is similar to the Curve Controls Not OK window. For more information about
the elements of this window, see the Curve Controls Not OK window above.
Window Items
The Re-measured Curve Controls Not OK window provides the following features.
Recommended selection is placed first.
The message Could not start calibrators' is displayed. A new calibrator curve must be run in
started.
If the new curve is OK, concentrations for current tests will be calculated.
dispensing of ImmunoCAP/EliA Well will resume.
is obvious that there is only a problem with the results of the Calibration Curve. A new calibration
This option shall be selected when a new calibration curve is not possible to process and it is a
risk that it is a problem with the results in general. A new calibration curve can be run later for
evaluation and the quality of the run can than be judged by checking the QC results.
Select Button
Minimize Button
Instrument Alerts
All alerts are shown as an Instrument Alert Display, which pops up when something abnormal
occurs. All alerts from Phadia 250 are sent to the IDM software and logged in the Messages tab
for each individual instrument.
Some alerts may cause the HOME button and the instrument icon to flash.
Three types of Alerts exists:
Error
Warning
Message
Alert Display
Message Field
Example: 0-1545 STOP SOLUTION BOTTLE EMPTY (ImmunoCAP dispensing is stopped)
Errors, messages, warnings are all coded. The first digit refers to the Subsystem and the second
is just a sequence number.
Subsystems
0 = Main program (Communication, Article definitions, missing liquid etc.)
1 = Subsystem 1 (Immuno Reaction Chamber, Fluorometer, Wash Supply)
2 = Subsystem 2 (Left Moving Arm, Level Detection)
3 = Subsystem 3 (Right Moving Arm, Level detection)
4 = Subsystem 4 (Process Chamber, Wash functions)
Extended Information Field
This area describes the malfunction more in detail, and one or several reasons can be pointed
out.
Next Alert - Previous Alert
When there are more Alerts present at the same time, you can toggle between them by using
these keys.
Release Keys
The Release Keys are used to continue the process, after the instrument has displayed an alert.
They are individually activated depending of which kind of alert it is, and also the function of
the key may differ. The main functions of the keys are: Release/Return, Retry, Continue, Stop,
Close, Mute.
Release/Return The Release/Return key is only active at very rare occasions,
for example when a power failure has occurred, and something
has stopped in the middle of a movement. RELEASE is used
for fulfillment of the movement. After release the key change
to RETURN for movement to home position.
Retry Retry to perform the failed function.
Continue The actual sample will be deleted. The processing will continue,
and new ImmunoCAP / EliA Wells and Samples dispensed.
Stop Stop aborts the processing.
Close Close closes the Alert Display.
Mute = Beep The beep sound is stopped.
Note: Selecting stop may result in an immediate termination of the assay. All processing reagents
and samples will be lost! A Super User must initialize ejection of ImmunoCAP and Elia well
from the reaction wheel. This Super User Maintenance is described in the Maintenance chapter.
Also, weekly maintenance is required according to the instructions in the Maintenance chapter.
Active keys area
The function of the active keys are displayed. In most cases they have the function described
above for each individual key, but there are exceptions.
Prev Page/Next Page
If the message requires more than one page you can toggle within the message with these keys.
Message
When an error occurs the message key will blink in red. By pressing MESSAGE you will return
to the main function, but if you try to do something, you will get a new message.
By pressing MESSAGE again you will come back to message mode.
Attention Light
On top of the instrument there is a light, to call for the attention of the operator.
0-Type Alerts
1-Type Alerts
2-Type Alerts
3-Type Alerts
4-Type Alerts
Power Failure
When a Power Failure occurs, the whole instrument is switched off. When the power returns,
the Primary Power is switched on, but the System Power is still switched off.
So, after a power failure, you will face a black instrument display.
If a power failure has occurred during an assay
1. Switch System Power on.
Result: The ISW starts, and when the Start Menu is displayed
2. Press ASSAY.
Result: The Confirmation Window opens.
3. Press OK
If the power failure has occurred during a movement you may get some Alert Display(s)
1. Do as the message(s) says.
2. Press BACK until you reach the Start Menu screen.
4. On the Utilities screen, select User Maintenance.
5. On the User Maintenance screen, select Initialize.
6. On the Initialize screen, press START.
Result: The instrument will make an initialization and check all sensors and restore to the
original condition.
Note: Initialization can be started from User Maintenance or Super User Maintenance.
When the initialization is complete, continue according to the instruction below:
1. Switch System Power off
2. Switch Primary Power off
3. Open Processing Chamber
4. Remove all ImmunoCAP by means of the ImmunoCAP Transfer Tool
5. Close Processing Chamber
6. Switch Primary Power on
7. Switch System Power on
8. Perform a Washing
Index
A D
Abort Loading 160 Daily Maintenance 379
Acceptance of an Analytical Run 324 Daily Rinse 207
Accuracy and Precision 366 Define Sample Rack 285
Acronyms and Abbreviations 31 Development/Stop Solution Information 183
Add Extra Calibrator/CC 167 Deviation score 372
Analytes 104 Diluent Information 176
Analytical Run 323 Dilution Well Information 179
Analytical Run (definition) 364 Disable test 283
Approve Results 319
Approve Run 318
Arithmetic mean 364
E
Assay - Method 153 Edit Doses 190
Assay Initializing 160 Eject ImmunoCAP/EliA Well 224
Assay Priming 161 Ejecting ImmunoCAP/EliA Well 225
Assay Processing 164 Electrical Safety 18
Assay Run 323, 329 Electrical Safety Classification 19
Assay Termination - Select Options 169 Electrical Specifications 121
Avoid problems 393 Electromagnetic Compatibility 19
EliA IgA 97
B EliA IgG 94
EliA IgM 99
Barcode Decode Window 109 EliA Technology
Barcode Settings 44 EliA IgA 97
Basic Configuration Settings 64 EliA IgG 94
Biochemical Safety 17 EliA IgM 99
Blank Measurement 162 EliA Well Description 13
Blank Run 204 End Assay 272
Error List 200
Errors/Warnings Settings 63
C European Directives and Standards (Mechanical Safety) 16
Calibration European Standards 19
Monthly Calibration 322 Expected Results 376
Calibration and Acceptance 321 Expired Reagents 156
Acceptance of an Analytical Run 324 Export Results 321
Analytical Run 323 External Quality Assessment 370
Assay Run 323
Calibration Curve 321 F
Monthly Calibration 322
Run Flow 323 FluoroC Measurement 217
Calibration Curve 321 FluoroC Run 216
Carrier Fluorometer 147
Loading Alternatives 301 Fluorometer Specifications 121
Carrier Loading Alternatives 301 Functional Test 218
screen 335
Carrier Loading Tray Information 188
G
Carrier Loading Tray Screen 335 General Instrument Specification 118
Carrier Storage Information 193 Glossary 24
Carrier Storage Tray 195 Good Laboratory Practice 12
Carrier Storage Tray Information 197
Change Loaded Tray 338
Change Loading Tray 338 I
Check Inventory 262
Check Request 262 IDM 107
Coefficient of variation 364 IDM Error Codes (Phadia 250) 330
Conjugate Information 184 IDM on Multiple Workstations 108
Copying results 224 IDM Printouts 112
Copyright and Trademarks 24 IDM Setup 32
IDM Shortcuts 108
ImmunoCAP and EliA Description 78 Instrument Screens (continued)
ImmunoCAP and EliA in Same Run 157 Carrier Storage Tray Information 197
ImmunoCAP Description 12 Intended Use
ImmunoCAP ECP 87 Phadia 250 11
ImmunoCAP EliA/Reagents Phadia IDM 10
Analytes 104 ISW Parameter Setting 229
ImmunoCAP Specific IgE 79 Miscellaneous settings 239
ImmunoCAP Specific IgG 83 Parameter Selection 229
ImmunoCAP Specific IgG4 85
ImmunoCAP ECP 87
L
ImmunoCAP Specific IgE 79 Laser Safety Considerations 15
ImmunoCAP Specific IgG 83 Load Additional Carriers 339
ImmunoCAP Specific IgG4 85 Load Carrier
ImmunoCAP Total IgE 81 Transfer to Storage 302
ImmunoCAP Tryptase 90 Load Reagents 173, 263, 296
ImmunoCAP Total IgE 81 Load Sample Tubes 289
ImmunoCAP Tryptase 90 Load Samples 270
ImmunoCAP/EliA Reagents 103 Loading Tray
Reagent Handling 106 Alternatives 301
Reagents 104 Primary Storage 334
ImmunoCAP/EliA Well Distribution 135 Registered 334
Infection Transfer Registered Carriers to Carrier Storage 341
avoiding 18 Unload and Clear Loading Tray 340
Prevention 18 Unload Carrier 340
risk of 17
Information
Service 202 M
Information Data Manager (IDM) 107
Initialize 206, 215 Mains Power Supply (AC) 18
Installation and Upgrade 32 Maintenance 378
Instrument Screens 152 Daily Maintenance 379
Abort Loading 160 Monthly Maintenance 382
Add Extra Calibrator/CC 167 Unscheduled Maintenance 387
Assay - Method 153 Weekly Maintenance 380
Assay Initializing 160 Maintenance Programs 202
Assay Priming 161 Blank Run 204
Assay Processing 164 Copying results 224
Assay Termination - Select Options 169 Daily Rinse 207
Blank Measurement 162 Eject ImmunoCAP/EliA Well 224
Conjugate Information 184 Ejecting ImmunoCAP/EliA Well 225
Development/Stop Solution Information 183 FluoroC Measurement 217
Diluent Information 176 FluoroC Run 216
Dilution Well Information 179 Functional Test 218
Edit Doses 190 Initialize 206, 215
Error List 200 Monthly Maintenance 209
Expired Reagents 156 Pipette Test 219
ImmunoCAP and EliA in Same Run 157 Prime 203
Load Reagents 173 Request Result to diskette/USB 223
Post Processing - End Assay Procedure 171 Sensor Setting 228
Reagent To Load 154 Super User Maintenance 214
Sample Information 192 Transfer Carriers between Storage Trays 226
Sample Load Rack Information 168 User Maintenance 202
Sample Rack Information 191 Verify ImmunoCAP Storage 222
Select Conjugate Tray 187 Washing 221
Select Strip Tray 182 Weekly Rinse 208
Shut Down 173 Manage Results 275
Start Menu 152 Manufacturer Information 20
Strip Information 179 Measurement (definition) 364
Temperature Monitor 201 Mechanical Safety 16
Utilities 172 Miscellaneous settings 239
Wait Refill 155 Miscellaneous Settings 56
Waste/Rinse/Wash Bottles Check 158 Mixed Technologies 361
Waste/Wash/Rinse Information 175 Module Settings 64
Carrier Loading Tray Information 188 Monthly Calibration 322
Carrier Storage Information 193 Monthly Maintenance 209, 382
Carrier Storage Tray 195 Monthly Report 372
Moving Arms 133 Phadia 250 Settings 38
Phadia 250 Specification 118
Electrical Specifications 121
O Fluorometer Specifications 121
On board Stability 295 General Instrument Specification 118
Operation Tubes Sample and Reagent Specifications 122
Quality Control Management 308 Phadia 250 System 107
Request Management 277 Phadia AB 20
Operator Requirements Copyright and Trademarks 24
Phadia 250 12 Phadia IDM
Phadia IDM 11 Approve Results 319
Operators Panel 126 Approve Run 318
Overview 123 Barcode Decode Window 109
Overview of the Assay Run 329 Define Sample Rack 285
Error Codes 330
Export Results 321
P IDM on Multiple Workstations 108
IDM Printouts 112
Parameter Selection 229 IDM Shortcuts 108
Parameter Setting Screen 39 Important System Parameters 36
Parameter Settings Intended Use 10
Barcode Settings 44 Operator Requirements 11
Basic Configuration Settings 64 Overview of the Assay Run 329
Errors/Warnings Settings 63 Print Loadlist 294
Miscellaneous Settings 56 Print Results 321
Module Settings 64 Reject Results 320
Pipetting Depth 45 Useful Preferences and Settings 32
Regional Settings 41 Phadia IDM Setup 32
Tube Settings 45 Installation and Upgrade 32
Parameters Pipette Test 219
changing 39 Pipetting Depth 45
Perform Wash Volume Check 360, 389 Post Processing - End Assay Procedure 171
Phadia 250 Power Supply 150
Parameter Settings 38 Prepare Samples 285
Phadia 250 Instrument Prime 203
Check Temperatures 332 Principal Functionality
End Assay 272 Phadia 250 11
Load Reagents 263, 296 Phadia IDM 11
Load Samples 270 Print Loadlist (IDM) 294
Operation 258 Print Results 321
Routine Operation 260 Process Monitoring 329
Sample and Rack Handling 288 Processing Chamber 144
Shut Down 260 Processing Flow 130
Start Assay 264
Start Up 259
Unload/Empty Reagents 305 Q
Phadia 250 Instrument Description 123
Fluorometer 147 Quality Assurance 363
ImmunoCAP/EliA Well Distribution 135 Quality Club 370
Moving Arms 133 Interpretation of Monthly Reports 373
Operators Panel 126 Interpretation of Summary Reports 373
Overview 123 Monthly Report 372
Power Supply 150 Programs in Quality Club 371
Processing Chamber 144 Summary Report 373
Processing Flow 130 Quality Club Samples
Reagent Loading 140 processing 313
Sample Loading 139 Quality Control
Strip Tray 132 EliA 369
System Reagents 142 Recommendations 368
Table 151 Targets and Limits 369
Warnings 151 Quality Control Charts 369
Wash/Rinse System 149 Quality Control Management 308
Waste Handling 147 Quality Controls 367
Phadia 250 Instrument Software 151 Quality Costs 377
Instrument Screens 152 Quality guide
ISW Parameter Setting 229 Introduction 363
Maintenance Programs 202 Quality Guide 363
Accuracy and Precision 366
Quality Guide (continued) Sensor Setting 228
Basic Concepts 364 Service 202
Expected Results 376 Shut Down 173
External Quality Assessment 370 Shut Down the Instrument 260
Quality Assurance 363 Standard deviation 364
Quality Club 370 Start Assay 264
Quality Control Charts 369 Start Menu 152
Quality Costs 377 Start the Instrument 259
Quality Controls 367 Strip Information 179
Strip Tray 132
Summary Report 373
R Super User Maintenance 214
Reagent Handling 106 SuperUser Information 12
Reagent Loading 140 System Computer Specifications 107
Reagent Management System Description
On board Stability 295 ImmunoCAP and EliA Description 78
Reagent To Load 154 ImmunoCAP/EliA Reagents 103
Reagents 104 Phadia 250 Instrument Description 123
Reflex test 281 Phadia 250 Instrument Software 151
Regional Settings 41 Phadia 250 Specification 118
Register and Load Carrier Loading Tray 336 Phadia 250 System 107
Register Carrier Loading Tray 336 System Reagents 142
Registered Loading Tray 334 System Specification
Change Tray 338 Phadia Information Data Manager (IDM) 107
Load Additional Carriers 339 System Computer Specifications 107
Unload and Clear 340
Unload Carrier 340 T
Unload Tray 341
Unregister Carrier 340 Table 151
Register and Load 336 Temperature Monitor 201
Transfer Carriers to Storage 341 Terminology 24
Registered Loading Trays Transfer Carriers between Storage Trays 226
Description 335 Transfer Registered Carriers 341
Reject Results 320 Tube Settings 45
Request Management 277 Tube type 278
Request Result to diskette/USB 223 Tubes Sample and Reagent Specifications 122
Result Management
Approve Results 319
Approve Run 318
U
Calibration and Acceptance 321 Unload and Clear Loading Tray 340
Export Results 321 Unload Carrier From Loading Tray 340
Print Results 321 Unload/Empty Reagents 305
Reject Results 320 Unscheduled Maintenance 387
Routine Operation 260 Unscheduled Operation
Check Inventory 262 Abort Current Process 334
Check Request 262 Add Extra Calibrator/CC 333
Manage Results 275 Initialization 332
Run Flow 323 Load Conjugate Tray 341
Load Missing Carrier 342
S Loading Reagents During an Assay Run 347
Pause Current Process 334
Safety 13 Replace Carrier Storage Tray 358
Biochemical Safety 17 User Maintenance 202
Electrical Safety 18 Utilities 172
Mechanical Safety 16
Warnings 13
Sample and Rack Handling 288
V
Sample Information 192 Variation in Results 365
Sample Load Rack Information 168 Verification of Instrument Performance 65
Sample Loading 139 Calculation of CV % Values 65
Sample Management 285 EliA IgG
Prepare Samples 285 EliA IgA and EliA IgM 73
Sample Rack Information 191 ImmunoCAP ECP and ImmunoCAP Tryptase 70
Sample tube type 278 ImmunoCAP Specific IgE 66
Select Conjugate Tray 187 ImmunoCAP Specific IgE 0-100 67
Select Strip Tray 182 ImmunoCAP Total IgE 69
Verification of Performance Wash Volume Check 360, 389
Calculation Model 74 Perform 360, 389
ImmunoCAP Specific IgG 71 Wash/Rinse System 149
ImmunoCAP Specific IgG4 72 Washing 221
Verify ImmunoCAP Storage 222 Waste Handling 147
Waste Management of Instruments 20
Waste/Rinse/Wash Bottles Check 158
W Waste/Wash/Rinse Information 175
Wait Refill 155 Weekly Maintenance 380
Warning Labels 14 Weekly Rinse 208
Warnings 13, 151

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Phadia 250 User Manual

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Issued April 2010

About this Manual

Good Laboratory Practice

This warning label is located between the Operators Panel

This warning label is located close to the Barcode

This label should only be used in the United States

Laser Safety Considerations

European Directives and Standards

How to Avoid Getting Infected

What to do after Serum and Plasma Contact

Mains Power Supply (AC)

Electrical Safety Classification

Waste Management of Instruments

To ensure the minimizing of disposal of Waste from Electrical and

Unknown Sometimes used as a synonym for a patient sample.

Phadia IDM Setup

Installation and Upgrade

Useful Preferences and Settings

Automatic Deletion of Results

Automatic Deletion of Requests

Displaying/Hiding an 1. In the IDM Workplace, click the PREFERENCES - F12

Positioning an 1. In the IDM Workplace, click the instrument name above

1. In the IDM Workplace, click the PREFERENCES - F12

Setting Automatic Deletion 1. Start the SettingsTool program. It is located in the

Adding Methods 1. In the IDM Workplace, click the SYSTEM - F8 button, or

Deleting Methods 1. In the IDM Workplace, click the SYSTEM - F8 button, or

Editing Methods 1. In the IDM Workplace, click the SYSTEM - F8 button, or

Importing Methods 1. In the IDM Workplace, click the SYSTEM - F8 button, or

Exporting Methods 1. In the IDM Workplace, click the SYSTEM - F8 button, or

Adding Articles 1. In the IDM Workplace, click the SYSTEM - F8 button, or

Deleting Articles 1. In the IDM Workplace, click the SYSTEM - F8 button, or

Editing Articles 1. In the IDM Workplace, click the SYSTEM - F8 button, or

Importing Articles 1. In the IDM Workplace, click the SYSTEM - F8 button, or

Adding Users 1. In the IDM Workplace, click the SYSTEM - F8 button, or

Deleting Users 1. In the IDM Workplace, click the SYSTEM - F8 button, or

Phadia 250 Settings

Opening the Parameter Setting Screen

Changing a Parameter Setting

5. Press REGISTER to save new parameter setting(s).

hh:mm:ss Hour:Minute:Second (24h)

hh:mm am/pm Hour:Minute am/pm (12h)

hh:mm Hour:Minute (24h)

hh:mm:ss Hour:Minute:Second (24h)

Sample Barcode (Max: 4 Items)

1-16 Enter a value between 1 and 16

Sample Barcode Length

1-16 Enter a value between 1 and 16

Bottom Level: The position where the pipette can detect

Calculating values to enter in Sample Tube settings

Example: (using three instead of five liquid detections):

Enter Tube Settings

Theoretical Level drop of 40 l in mm at different tube diameters

Diameter Level drop Pipetting depth

4.0 3.18 3.78

5.0 2.04 2.64

6.0 1.41 2.01

7.0 1.04 1.64

8.0 0.80 1.40

9.0 0.63 1.23

10.0 0.51 1.11

12.0 0.35 0.95