HumaMeter A1c

HumaMeter A1c

1. Product Overview
2. HbA1c and Diabetes
3. Performing a Test
4. Basic Maintenance
5. Summary

Page 2

HumaMeter A1c

Product Overview
HumaMeter A1c is a revolution in HbA1c measurement:
It combines market-leading PoC analyser accuracy with low
cost, easy to use technology.

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HumaMeter A1c

HumaMeter A1c Analyser

Large
backlit
display

Door with
automatic
switch

Reagent
cartridge

Barcode
scanner

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HumaMeter A1c

Product Features

Easy to use
Step by step
instructions on
display
Multi-lingual menu
Innovative blood
collector allows
easy sampling

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HumaMeter A1c

Practical

Data

Fast and
accurate

Stores up to 7,000
records

Self-testing

Results in
4 minutes

Barcode
identification

Small sample size (4

l)

Imprecision:
CV <3% at 7% A1c

USB port for PC

Compact size
Weight: 0.7kg

Barcode reader for

calibration data,
patient and
operator ID

Accessories
Optional label
printer

Technical Information
Boronate Affinity methodology (interference free)
Traceable to the IFCC reference method
Imprecision: CV <3%

(at 7% A1c)

Measuring range:
4-15% A1c (20-140 mmol/mol)
Unaffected by Hb variants (which do not result in reduced erythrocyte life span)
User selectable dual reporting.
Choose from % DCCT, IFCC mmol/mol, % JDS, eAG mg/dL or eAG mmol/L
Optional printer

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HumaMeter A1c

HumaMeter A1c Reagent Test Cartridges

Small sample size required (4 L)
Fast measuring time (approx. 4 minutes)
Reagent stability of 12 months at 2-8 C;
thereof up to 90 days @ room temp. (uncooled)*
Sold in compact boxes of 50 (2 * 25) reagent cartridges with
50+ sample sticks; imprinted calibration barcode
*18 25C

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HumaMeter A1c

Components and Accessories

Ordering information:
Product
HumaMeter A1c analyzer

Included

HumaMeter HbA1c reagent kit

50 test cartridges, 50 sample sticks, 1 IFU,

calibration barcode

Analyzer, User Manual (GB, F, E, RUS), Barcode

scanner, Power supply

HumaMeter HbA1c control

Ref. No.
16080
16085/50
16086

Optional accessories:
Product

Ref. No.

Printer HumaMeter A1c

16081

Printer label rolls HumaMeter A1c (320 labels)

16082

Spare parts:
There are no serviceable parts. If broken or lost, the following parts can be exchanged by the user:
Barcode scanner HumaMeter A1c (Ref. No. 16083)
Printer cable HumaMeter A1c (Ref. No. 16081/1)

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HumaMeter A1c

HbA1c and Diabetes

HbA1c and Diabetes

Diabetes mellitus (commonly : Diabetes):
-Diseases in which a person has high blood sugar (=Glucose)
-Reasons: Body produces not enough insulin or cells do not respond to the insulin produced.
-2 Types:

Type 1 diabetes (Insulin-dependent diabetes):

Caused by loss of insulin-producing beta cells in pancreas.
Usually young people.

Type 2 diabetes (Non-insulin dependent diabetes):

Results from insulin resistance (cells fail to use insulin properly).
Sometimes combined with insulin deficiency.
Typically in adults over 40 and overweight patients.

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HumaMeter A1c

HbA1c and Diabetes

Causes of Diabetes
High Blood Pressure
High blood triglyceride (fat) levels
Poor diet (processed simple carbs and sugars)
Sedentary lifestyle
Obesity or being overweight
Increasing age
Pregnancy (gestational diabetes)
Pancreatitis

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HumaMeter A1c

HbA1c and Diabetes

Signs and Symptoms of Diabetes
Excessive thirst
Frequent urination
Blurry vision
Sedentary lifestyle
Tingling or numbness in the hand and feet
Wounds that dont heal
Extreme unexplained fatigue

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HumaMeter A1c

HbA1c and Diabetes

Diabetes: High blood sugar (=Glucose)

Blood Glucose level

is used for
DIABETES Diagnosis &
DIABETES Monitoring

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HumaMeter A1c

HbA1c and Diabetes

Functions of Blood:
Transport

Regulation

of fluid and electrolyte balance, temperature

Protection

against bacteria, viruses, toxins

of oxygen, nutrients, electrolytes,

hormones and enzymes throughout the body

Wound healing through clotting mechanism

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HumaMeter A1c

HbA1c and Diabetes

Components of Blood
Red Blood Cells (RBC) or Erythrocytes ~99% of blood cells
RBC contain hemoglobin, an oxygen-carrying protein. Oxygen
binds to hemoglobin in lungs and is the transported to the tissues.

White blood cells (WBC) or Leukocytes

Initiate immune responses, < 1% of blood cells.

Platelets (PLT) or Thrombocytes

Crucial for blood clotting & wound healing.

Plasma
Yellow fluid that carries all blood cells; makes up ~55% of blood.

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HumaMeter A1c

HbA1c and Diabetes

Hemoglobin and Glucose
Glucose rapidly diffuses into RBC by
facilitated diffusion.
N terminal valine of hemoglobin
alpha chain is available for
irreversible glycation:
Hemoglobin Hb HbA1c
Hb glycation level (= HbA1c level)
is proportional to glucose
concentration in plasma !

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HumaMeter A1c

HbA1c and Diabetes

WHY HbA1c?

RBC lifespan: 8-12 weeks

HbA1c concentration indicates average
blood glucose level over previous 8-12
weeks

HbA1c testing - one of the best ways to ensure

good diabetes control as it reports an overall
level, not a snap-shot concentration

HbA1c is not the same as a glucose

measurement!
Note: A patients HbA1c level is affected
e.g. by RBC lifespan, which may be
decreased in some conditions.

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HumaMeter A1c

Summary HbA1c principle - RBC Red blood cells,

Hemoglobin & Glucose
RBC: Uptake, transport and release of oxygen
Oxygen bound to Hemoglobin Hb
Glucose easily moves between blood & RBC
Irreversible Glycation (=binding of Glucose) of Hb
Glycated Hb - HbA1c
Level of Glycation ~ Glucose in plasma
RBC lifespan = 8-12 weeks: HbA1c concentration indicates average blood
glucose levels last 8-12 weeks
HbA1c reports an overall glucose concentration, not only a snap-shot
concentration!
HbA1c testing - the best way to ensure good diabetes Discovery & Control!

HbA1c and Diabetes

HbA1c LEVELS
Commonly used clinical ranges for glycated hemoglobin (HbA1c) are:

Normal:

< 5.7%

Pre-diabetes: 5.7% - 6.4%

Diabetic:

6.5% or higher

Targets should be set for each individual, taking into consideration

their risk of severe hyperglycaemia, cardiovascular status and comorbidities.
Note: The American Diabetes Association recommends a goal of less than 7% DCCT (53 mmol/mol
IFCC) for effective management of diabetes and to minimize long-term diabetic complications.

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HumaMeter A1c

Performing a Test

Performing a Test
A Few Easy Steps plus fool-proof display-guidance
Scan lot calibration,
remove cartridge foil
and insert into
analyser.

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HumaMeter A1c

Press reagent bead

into the cartridge.

Take blood sample.

Close lid.

Insert into cartridge

and snap the stick.

Results in 4 minutes.

Performing a Test
Set Up
Make sure a tray of cartridges & the analyser
are equilibrated to working temperature
(room temperature)

Page 22

Scan lot calibration barcode

Remove foil lid from cartridge
Place cartridge into analyser
When prompted, press reagent bead into the
cartridge with blunt end of the sample stick

HumaMeter A1c

Performing a Test
Preparing to Take a Blood Sample

1. Make sure your patient sits comfortably.

2. There should be good blood circulation in
the hand from which the sample is to be
taken.
3. The hand should be warm and relaxed.
If in doubt, warm the hand in lukewarm
water.

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HumaMeter A1c

Performing a Test
Stimulating Blood Circulation
1. Lightly massage the fingers in order to
stimulate the circulation.
2. Operator should wear protective gloves.
3. Middle or ring finger should be used for
taking a sample. Patient should not wear a
ring on the finger used for sampling.
4. Disinfect the puncture site and allow it to
dry completely.

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HumaMeter A1c

Performing a Test
Lancing the Finger
1. Lance the finger on the side of the fingertip.
This is less painful and the blood flow is better.

2. Press lightly on the fingertip and puncture it with a lancet.

3. A lancet that will create a blood flow of 10-20 l is
recommended.
4. Blot away the first drop of blood.
5. If necessary, press the finger gently again to get a second
drop of blood which is large enough to fill the capillary .
6. Avoid milking the finger for blood.
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HumaMeter A1c

Performing a Test
Filling the Sample Stick
1. Hold the sample stick with the blood collector
and lightly touch the pointed tip on the surface
of the blood droplet.
2. Hold the stick in this position until it is filled
completely with blood.
3. Check that the blood collector cavity is
completely filled and is free of air bubbles.
4. Do not top-up the blood collector if it does not
completely fill with blood. Instead, repeat the
process with a fresh blood sample and stick.

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HumaMeter A1c

Performing a Test
Calibration
Lot calibration is performed by
scanning in the bar-code label
found on of each cartridge box
Lot calibration can be done:

When the analyser is idle

When the analyser requests it =

When Scan Lot Barcode appears
on the screen

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HumaMeter A1c

Performing a Test
Calibration (Cont.)
Each reagent lot is directly calibrated to IFCC standards received from
the European Reference Laboratory.
Cartridge lot calibration is entered into the instrument by scanning the
bar code on the box of reagents.
Once the test is finished the results will be expressed in:
% HbA1c/total Hb traceable to DCCT
mmol/mol traceable to the IFCC standard
Reporting methods JDS, Mono-S and eAG also can be selected from
set-up menu

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HumaMeter A1c

Performing a Test
Measuring Procedure
1. Insert the blood collector end of the
sample stick into the cartridge that is in
the analyser.
2. Snap off the sample stick handle.
3. Close the lid of the analyser.
4. The result will appear on the screen
within ~4 minutes.

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HumaMeter A1c

Basic Maintenance

Basic Maintenance
Cleaning Procedure
Clean the analyser with a
non-abrasive lint free cloth.
Use a mild detergent or
commercially available
disinfectant if necessary.
Always turn off the analyser
by unplugging the power
supply before performing any
cleaning operation.

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HumaMeter A1c

Basic Maintenance
Storage
Turn off the analyser on a weekly basis for a
minimum of 10 seconds so that when it is turned
back on again, it will perform the internal self-checks.
If the instrument is stored when not in use, ensure
that the mains cord is not liable to damage or kinking.
The analyser is calibrated by the manufacturer and
there are no user-serviceable parts.
Reagent shelf-life of up to 90 days (un-refrigerated).
Total Reagent stability of 12 months at 2-8 C.

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HumaMeter A1c

Competition

Competitor analysis I

HumaMeter A1c

CERTIFICATION

Axis Shield
Nycocard

NGSP and IFCC

certification

METHODOLOGY
TIME TO RESULT

MEASUREMENT
RANGE % A1C
SAMPLE VOLUME
IMPRECISION, CV
AT 7% A1C
SPECIMEN TYPE

Hemocue 501
(OEM of Clover)

NGSP certified
NGSP certified
Barcode calibration Barcode calibration

Boronate Affinity
Fluorescence
Quenching
<4 mins

Infopia Clover

Boronate Affinity
reflectance
3 mins

Boronate Affinity

Boronate Affinity

Inverse
Amperometry
5 mins

Inverse
Amperometry
5 mins

Boditech iCHROMA

Ceragem Labona
Check

Ceragem CeraStat 2000

Bio-Rad IN2IT

NGSP certified

NGSP and IFCC

certification

NGSP certified

NGSP certified

Immunological
>12 mins

Boronate Affinity
with optical
reflectance
3 mins

Boronate Affinity
with optical
reflectance
3 mins

Chromato-graphy
10 mins

4 - 14%
10 ul
<4%

Boronate Affinity

4 - 15%
4 l

4 - 15%
5 l

4 - 14%
4 l

4 - 14%
4 l

4 - 15%
5 l

4 - 15%
5 ul

HbA1c: 4 % - 15
%, Hemoglobin: 5 26 g/dL
5 ul

<3%

8.5%

<3%

<3%

<5%

2.8 - 3.8%

No info

Capillary
No

Capillary
No

Capillary
Yes

Capillary & venous Finger & venous

No
No

Capillary & venous Capillary & venous Capillary & venous

No
No
No

AFFECTED BY HB
VARIANTS*

REAGENT TYPE

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Cartridge:
Ready to use

Test disc:
Add reagents to
sample and disc

Cartridge:
Shake reagents
before taking
sample

Cartridge:
Lateral flow strip
Shake reagents
before taking
sample

Sample capillary Sample capillary

with hemolysis
with hemolysis
vials or step
vials or step
dropper, 2 liquid
dropper, 2 liquid
reagents, pipette, reagents, pipette,
cartridge
cartridge

Cartridge:
Ready to use

Competitor analysis II

MEMORY: PATIENT
& QUALITY
CONTROL

REAGENT
STORAGE

Axis Shield
Nycocard

Infopia Clover

Hemocue 501
(OEM of Clover)

7,000 P & QC

Last Patient

200 P

200 P

Boditech iCHROMA

12 months @ 2 8C; thereof 90

days at room
2 - 8C 90 days at
temperature
room temperature Room temperature Room temperature 2 - 8C 20 months

18 - 30C
Yes

18 - 30C
No

17 - 32C
Optional

17 - 32C
Optional

10 - 40C
No

PRINTER

External

No

External

External

External

AC or DC9

AC or DC9

QUALITY CONTROL

SELF-TEST
PC INTERFACE

Ceragem Labona Ceragem CeraCheck

Stat 2000

300 results

OPERATING
CONDITIONS
PATIENT/USER ID

POWER

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HumaMeter A1c

300 results

Bio-Rad IN2IT

200 P & QC

2 - 8C 30 days at
room temperature

2 - 8C
20 - 25 C;
20 - 25 C;
Humidity:15 - 75% Humidity:15 - 75%
No
No (Patient ID
manual entry)
Integrated thermal Integrated thermal
printer
printer

18 - 30C
No

External

AC

AC

battery

battery

AC or 12v battery

AC

AC

AC or 4 type AA
batteries

2 levels

2 levels

No

No

No

2 levels

2 levels

2 levels Must be
diluted

During start up
Optics check
before each test

Calibration check

Check cartridge
supplied

Check cartridge
supplied

Yes

Yes

Yes

Optics check

Serial port

Serial port, USB

port

Serial port, USB

port

None

Serial port, USB

port

USB port

Serial port

None

Competitor analysis III

HumaMeter A1c
DEVICE
CHARACTERISTICS

Axis Shield
Nycocard
DCCT reporting
only

Infopia Clover

Hemocue 501
(OEM of Clover)

Boditech iCHROMA

Dual reporting

Dual reporting

DCCT reporting
only

Multilingual
display

No
CE

Bio-Rad IN2IT

Reporting either
DCCT or IFCC,
touch screen

Reporting either
DCCT or IFCC
and Hb, touch
screen

Symbols and
codes used on
display

Hemoglobin
CE
CLIA waived

No
CLIA waived

No
CLIA waived

Requires multiple
pipette steps

Dual Reporting,
user selectable
units % DCCT,
mmol/mol IFCC,
% JDS, eAG
mg/dl and eAG
mmol/l
OTHER ANALYSIS
APPROVALS

Ceragem Labona Ceragem CeraCheck

Stat 2000

CRP, D-Dimer,
Micro Albumin
510(k)

Blood glucose
PSA, D-dimer,
Optional module HS-CRP, TROP
510(k)

No
CE

MAXIMUM TIME
PERMITTED
AFTER BLOOD
COLLECTION
SIZE AND WEIGHT

7 minutes
30 seconds
95x205x135 mm 200x170x170mm 200x200x139mm 185x80x250mm
0.7kg
0.54kg
1.4kg
1.3kg
OEM of Clover

OTHER

Page 36

5 minute
178x195x77mm
0.73 kg

5 minute
10 seconds
10 seconds
178x195x77mm 140x100x145mm 140x100x145mm
0.73 kg
0.84kg
0.84 kg
Noisy in use

Insert cartridge
into machine then
insert reagent
Easy operation
pack with sample
Bulky cartridges
Noisy in use
(2 steps instead Reagents stable
take up lots of
Reagents stable
of
1)
fridge
space
at room
for 20 months Updated nycocard
Bulky cartridges
temperature for 1 Multi-step manual 1 cartridge must Multi step manual with multi-step Multi-step manual
take up lots of
month
process
be assembled
process
manual process
process
refrigerator space

RECAP

Name some of the most common causes of diabetes.

Name some of the symptoms of diabetes.
What does HumaMeter A1c measure?
Why must the reagent cartridges be removed from storage
40 minutes before use?
Which fingers should be used for taking a blood sample?
How long does HumaMeter A1c take to provide results?

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HumaMeter A1c