smart HbA1c Test

Summary and Explanation of the Test:

Throughout the circulatory life of the red cell, Haemoglobin A1c (HbA1c) is formed continuously by adduction of glucose to the N-terminal of the haemoglobin beta chain. This process which is non enzymatic reflects the average exposure of haemoglobin to glucose over an extended period. Studies have shown that HbA1c on diabetic subjects was 2-3 fold over levels found in normal individuals.

Method-Range:

Enzymatic HbA1c test: Typical Range (Lot pending!) NGSP: 4,0% - 14,0%

Principal:

Endpoint measurement of the HbA1c- Concentration at 700nm.

HbA1c Test Procedure

Test kit preparation: Allow single test min. 10 minutes to warm to room temperature by placing the test into the test kit rack. Put test kit package back into refrigerator.

1a. Sample preparation

Direct from finger brick

HbA1c blood collection

1a.1) Aspirate 20µl whole blood using the smart capillary tube

HbA1c sample preparation

1a.2) Release filled capillary tube into lysing cup (prefilled with R1b)

1b. Sample preparation

From EDTA tube

HbA1c EDTA primary tube blood collection

1b.1) Aspirate 20µl EDTA whole blood

HbA1c EDTA primary tube sample preparation

1b.2) Dispense 20µl sample into lysing cup (prefilled with R1b)

2. Sample preparation

HbA1c dispenser (lysing buffer)

Dispense 2 pump strokes lysing buffer into lysing cup

HbA1c lysate cup shaking

Shake lysing cup vigorously 6-8 times and wait 6 minutes until complete lysis is evident =Lysate


3. Test application
insert RFID card analyser is reading:
  • calibration curve
  • test procedure
  • expiry date
  • lot number
 pipette 150µl lysate into ERS (Eurolyser-Reagent-System) cuvette apply patented ERS cap insert ERS into smart analyser, press "start" - read result

Test specification


  • Enzymatic assay
  • precision: cv < 3% (at 5% HbA1c ngsp)
  • linearity:
    • ngsp: 4.0-14%
  • throughput: 14 samples/hour

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