One step test for HbA1c is intended for the quatitative measurement of HbA1c in whole blood. This test is used as an aid for monitoring glycemic control in diabetes. In addition, it can identify people at risk of developing the disease and ongoing monitoring.
The test uses an anti-human Hb monoclonal antibody conjugated with colloidal gold and anti-human HbA1c monoclonal antibody coated on the test line. After the sample has been applied to the test strip, the gold-labelled anti-human Hb monoclonal antibody binds with the HbA1c and Hb in sample proportinally and forms marked antigen-antibody complex. The complex moves to the detection zone by capillary action. Then marked antigen-antibody complex is captures on the line test line by the anti-human HbA1c
monolonal antibody. The color intensity of the test line increases in propotion to the amount of HbA1c in sample.
Then insert test card into FIA8000 Quantitative Immunassay Analyzer (hereafter referred to as FIA8000), the concentration of HbA1c
is measured and displayed on the screen. The HbA1c concentration of HbA1c concenration of HbA1c is stored in the FIA8000 and is available on demand. The result can be transmitted to the lab or hospital information system, if it is connected to FIA8000.