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Test i-CHROMATM HbA1c Test

General Information
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.

Key Features of i-CHROMATM HbA1c Test


Quantitative Test Result Sample Type: Whole blood Sample volume: 5 l 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
Comparison Data with Variant II

Diabetes

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.

i-CHROMATM HbA1c Test


Test Procedure
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 L 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 L 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 L of the mixture onto the sample well and 100 L 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.

Diabetes

i-CHROMA

TM

same lot number


Check the contents : 1 ID chip, 25 Test Devices, 25 tubes of Hemolysis Buffer, 1 vial of Detection Buffer Check and make sure that the Test Device lot number matches ID chip lot number. Insert the ID chip into the instrumet.

Contents

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

Press "Select"

10 times

Add 100ul of Detection Buffer to Hemolysis Buffer tube.

Collect 5ul of sample directly from a fingertip or prepared specimen using a capillary tube.

Drop the sample containing capillary into the tube containing the mixture of hemolysis buffer and detection buffer. (from step #5)

the mixture of buffer and the sample blood has to be used within 30 seconds.

Shake the tube 10 times or more until the blood is completely out of collection capillary :

sample window

Hemoglobin window

of (of sample buffers from 9 Collect 50ulandthe mixture step #8)

the mixture onto the sample well 10 Transferslowly. of the Test Device

11

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

12

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

12 minutes

13

Wait 12 minutes.

14

Place the Test Device on the holder and push all way back.

15

Press "Select"

Read the result on the display screen.