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i-CHROMATM HbA1c Test

Glycated proteins are formed post-translationally from the slow, nonenzymatic reaction between glucose and

amino groups on proteins. For hemoglobin, the rate of synthesis of Hemoglobin A1c (HbA1c) is principally a

function of the concentration of glucose to which the erythrocytes are exposed. HbA1c is a clinically useful index

of mean glycemia during the preceding 120 days, the average life span of erythrocytes. Carefully controlled

studies have documented a close relationship between the concentrations of HbA1c and mean glycemia, while

routine determinations of blood glucose by patients or by their healthcare providers are not considered as

reliable as HbA1c to quantify mean glycemia. Concentrations of other blood-based glycated proteins (e.g.,

glycated serum or plasma proteins, "fructosamine") also reflect mean glycemia, but over a much shorter time than

HbA1c: 15-30 days and 60-120 days, respectively.

General Information

Key Features of i-CHROMATM HbA1c Test

• Quantitative Test Result

• Sample Type: Whole blood

• Sample volume: 5 µl

• Detection Limit: 4 %

• Working range: 4 %~15 %

• Cut Off: < 6.5 %

• Precision: CV(%) ≤5% in working range.

• Long Shelf Life: 20 months

• Fast Test Result: 12 minutes

• User Friendliness: Pipette Used

• Comparable Test Result with Full Automatic Analyzer

• No Calibration Needed

Principle

The i-CHROMATM HbA1c is based on fluorescecnce immunoassay technology. It uses competition immunodetection

method. Whole blood from blood specimen is added to the mixture of hemolysis buffer and detection buffer which

results in hemolysis of red blood cells. The mixture containing HbA1c from the hemolyzed red blood cells and

fluorescence-labeled HbA1c peptides from detection buffer is loaded onto the sample well of Test Device and migrates

the nitrocellulose matrix of test strip by capillary action. HbA1c of whole blood competes with fluorescence-labeled

HbA1c peptides for binding sites on HbA1c antibodies of nitrocellulose matrix.

Thus, the concentration of HbA1c antigen in blood specimen shows inversely proportional relationship with intensity of

fluorescence of HbA1c-peptides. The result is displayed on i-CHROMATM Reader in units of percentage.

Comparison Data with Variant II

i-CHROMATM HbA1c Test

1. Place a Test Device on a clean, dust-free flat surface.

2. Check and insert ID chip into the instrument. Make sure that Test Device lot # matches ID chip lot #.

3. Take out a Detector Buffer vial from the refrigerator and leave it at room temperature for 20 minutes.

4. Take 100 µL of Detection Buffer from the vial, put into the pre-dispensed Hemolysis Buffer tube and mix

well.

5. Prick a fingertip and prepare blood sample in a test tube.

6. Draw 5 µL of Whole Blood with a glass capillary.

7. Put the glass capillary into Hemolysis Buffer tube and shake the tube up and down ten times to take the

blood out of the capillary.

8. Apply 50 µL of the mixture onto the sample well and 100 µL onto the Hb sample well of Test Device

(refer to the picture above).

9. Leave Test Device at room temperature for 12 minutes before inserting the device into the holder.

10. To start scanning, insert Test Device onto the holder of i-CHROMTM Reader and press “SELECT” button.

Checking the direction of Test Device, push the device back all the way.

11. The instrument will automatically start to scan Test Device immediately.

12. Read the results on the display screen of i-CHROMATM Reader or the printer output.

Test Procedure

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i-CHROMATM HbA1c Test

12 minutes

same lot number

7

13

8

14 15

9

5

10 11

6

4

12

Hemoglobin window

Contents box 25 Test Device pouches(1 Test Device per pouch)

Test Device 1 ID chip 1 Manual

Hemolysis Buffer Pouch 25 tubes of Homolysis Buffer

1 Detection Buffer Vial

Check the contents : 1 ID chip, 25 Test Devices,25 tubes of Hemolysis Buffer,1 vial of Detection Buffer

Check and make sure thatthe Test Device lot numbermatches ID chip lot number.

Insert the ID chip into theinstrumet.

Press "Select"

Add 100ul of Detection Buffer to Hemolysis Buffer tube.Drop the sample containingcapillary into the tube containingthe mixture of hemolysis bufferand detection buffer.(from step #5)

Shake the tube 10 times or moreuntil the blood is completely outof collection capillary :the mixture of buffer and thesample blood has to be used within 30 seconds.

Collect 5ul of sample directlyfrom a fingertip or preparedspecimen using a capillarytube.

10 times

Collect 50ul of the mixture(of sample and buffers fromstep #8)

Transfer the mixture ontothe sample well of the TestDevice slowly.

Collect 100ul of the mixture(of sample and buffers fromstep #8)

Transfer the mixture onto theHemogloin Window of the Test Device slowly.

Wait 12 minutes. Place the Test Device onthe holder and push allway back.

Press "Select" Read the result on the display screen.

sample window

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TMi-CHROMA