Diagnostic Kit for HbA1c (Immunofluorescence Assay) is intended for in-vitro quantitative determination of HbA1c in human whole blood as an aid in the diagnosis of diabetes and in identifying patients who may be at risk for developing diabetes.
CE marked
For professional in-vitro diagnostic use
Working only with MPQuanti® Immunofluorescence Analyzer
Linear working range: 4 ̴14.5%, R≥0.990
Test results should be interpreted at 10 minutes
A marker of long-term metabolic control in persons with diabetes
mellitus
Product Description
Diagnostic Kit for HbA1c is based on fluorescence immunoassay technology.
The test cassette includes HbA1c antibody coated fluorophores, Rabbit IgG coated fluorophores, Hb antibody and Goat anti Rabbit IgG coated on the membrane.
The sample moves through the strip from sample pad to absorbent pad. HbA1c in the sample, attaches to the HbA1c antibody which is conjugated with fluorescent microspheres. Then captured by hemoglobin (Hb) antibody coated on the nitrocellulose membrane. The concentration of HbA1c in the sample correlates linearly with the fluorescence signal intensity. According to the two fluorescence intensity, the MP Fluorescent Immunoassay Analyzer could calculate the value of HbA1c percentage in the sample.
The HbA1c Test Cassette should only be used by approved medical professionals.
Usage Statement
For professional in vitro diagnostic use only.
Should not be used as the sole criterion for treatment decisions.
Usage Statement
For professional in vitro diagnostic use only