05885442001V4.

Total MPA Controls

04357230 190 2 x 5mL LevelI
2 x 5mL LevelII
2 x 5mL LevelIII

English Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.
System information
For use on Roche/Hitachicobasc analyzers the control codes are: All human material should be considered potentially infectious. All products
derived from human blood are prepared exclusively from the blood of
Level I (TMPA1) Code 107 donors tested individually and shown to be free from HBsAg and antibodies
to HCV and HIV.
Level II (TMPA2) Code 108 The testing methods applied were FDA-approved or cleared in compliance
Level III (TMPA3) Code 109 with the European Directive 98/79/EC, AnnexII, ListA.
However, as no testing method can rule out the potential risk of infection
For use on COBASINTEGRA analyzers the systemIDs are: with absolute certainty, the material should be handled with the same level
of care as a patient specimen. In the event of exposure, the directives of the
Level I (TMPA1) systemID 0769355 responsible health authorities should be followed.1,2
Level II (TMPA2) systemID 0769363 Handling
Level III (TMPA3) systemID 0769377 The product is readyforuse. Prior to use swirl bottle carefully to obtain a
homogenous solution. Record the date that the bottle was opened on the
Intended use relevant bottle label.
The Roche TotalMPAControls are for use in quality control by monitoring The enclosed barcoded labels are intended exclusively for cobasc
accuracy and precision for the quantitative method as specified in the value systems to identify the control. Attach the barcoded labels to the tubes
sheets. carrying the sample cups containing the control material.
Summary Storage and stability
TotalMPAControls consist of 3 ready-for-use controls based on human Store at 28C.
serum. Stability:
The adjusted concentrations of the control components are usually in the
normal range or at the normal/pathological threshold. Unopened: up to the stated expiration date at 28C
Some methods specified in the relevant value sheet may not be available in After opening: 6months, or until the printed expiration date,
all countries. whichever comes first, at 28C
Reagents working solutions Store controls tightly capped when not in use.
Reactive components:
Materials provided
Human serum with added mycophenolic acid.
Non-reactive components: See Reagents working solutions section
Preservative Barcoded labels
The concentrations of the control components are lot-specific. The exact Materials required (but not provided)
target values are given in the electronically available or enclosed value Roche system reagents and clinical chemistry analyzers
sheets.
General laboratory equipment
The values are also encoded in the enclosed control barcode sheets for
COBASINTEGRA analyzers. Assay
For the cobasc analyzers (except for the cobasc111 analyzer) the values Dispense the required volume into a sample cup and analyze in the same
are encoded in electronic files sent via the cobas link to the analyzers. way as patient samples.
The controls should be run daily in parallel with patient samples and after
Target values and ranges every calibration. Control intervals must be adapted to individual
The target values were determined using the method stated in the laboratorys requirements.
electronically available or enclosed value sheets. Determinations for Roche
methods were performed under strictly standardized conditions on Roche Follow the applicable government regulations and local guidelines for
analyzers using Roche system reagents and the Roche master calibrator. quality control.
The target value specified is the mean of all values obtained. The References
corresponding control range is calculated as the target value 20%. 1 Occupational Safety and Health Standards: Bloodborne pathogens.
Results should be within the defined ranges. Each laboratory should (29CFR Part 1910.1030). Fed. Register.
establish corrective measures to be taken if values fall outside the range.
2 Directive 2000/54/EC of the European Parliament and Council of
A clinically insignificant difference may be seen between the value(s) listed 18September 2000 on the protection of workers from risks related to
on the value sheet and the value(s) obtained from the instrument readable exposure to biological agents at work.
data. This is caused by:
A point (period/stop) is always used in this Method Sheet as the decimal
the rounding of value(s) during conversion from the unit in the separator to mark the border between the integral and the fractional parts of
instrument readable data to the unit that is being used. a decimal numeral. Separators for thousands are not used.
the calculation of the ranges by the analyzer using the percentage Symbols
values for the ranges encoded in the barcodes.
Roche Diagnostics uses the following symbols and signs in addition to
The traceability of the target value is given in the respective Method Sheets those listed in the ISO 152231 standard.
for the system reagents to be used in combination with the recommended
calibrator. Contents of kit
Precautions and warnings Volume after reconstitution or mixing
For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory
reagents.

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Total MPA Controls

FOR US CUSTOMERS ONLY: LIMITED WARRANTY
Roche Diagnostics warrants that this product will meet the specifications
stated in the labeling when used in accordance with such labeling and will
be free from defects in material and workmanship until the expiration date
printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY
OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE
FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL
DAMAGES.
COBAS, COBASC and COBASINTEGRA are trademarks of Roche.
All other product names and trademarks are the property of their respective owners.
Significant additions or changes are indicated by a change bar in the margin.
2013, Roche Diagnostics

Roche Diagnostics GmbH, SandhoferStrasse116, D-68305 Mannheim

www.roche.com
Distribution in USA by:
Roche Diagnostics, Indianapolis, IN
US Customer Technical Support 1-800-428-2336

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