The CDIATM Hemoglobin A1c Immunofluorescence Test Cassette is designed for quantitative determination of hemoglobin A1c in human whole blood.
The test uses an anti-human HbA1c monoclonal antibody conjugated with fluorescence latex and another anti-human HbA1c monoclonal antibody coated on the test line. After the sample has been applied to the test strip, the fluorescence latex-labelled anti-human HbA1c monoclonal antibody binds with the HbA1c in sample and forms a marked antigen-antibody complex. This complex moves to the test card detection zone by capillary action. Then marked antigen-antibody complex is captured on the test line by the anti-human HbA1c monoclonal antibody. The fluorescence intensity of the test line increases in proportion to the amount of HbA1c in sample. Then insert test card into the Fluorescent Immunoassay Analyzer FIA7100, the concentration of HbA1c in sample will be determined and displayed on the screen.
Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average plasma glucose concentration. The test is limited to a three-month average because the lifespan of a red blood cell is four months (120 days). However, since RBCs do not all undergo lysis at the same time, HbA1C is taken as a limited measure of 3 months. It is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose. HbA1c is a measure of the beta-N-1-deoxy fructosyl component of hemoglobin.In diabetes mellitus, higher amounts of glycated hemoglobin, indicating poorer control of blood glucose levels, have been associated with cardiovascular disease, nephropathy, neuropathy, and retinopathy. This kit is intended to use in quantitative detection of HbA1c content in human whole blood.