Product Name: Glycated Hemoglobin Determination Kit (Fluorescence Immunoassay)

Abbreviation:  HbA1c

APPLICATION:

The reagents are used for quantitative determination of glycated hemoglobin in human whole blood in vitro. They are for professional use only.

Glycated hemoglobin (HbA1c) refers to the non-enzymatic binding of hemoglobin and sugar in the blood, and its syntheses rate is directly proportional to the concentration of sugar in the environment of red blood cells. Therefore, the proportion of glycosylated hemoglobin can reflect the average blood glucose level of human body within 1-2 months, and it is a good indicator to determine the long-term control of diabetes.

PRCINCIPLE:

When the sample is added to the sample hole on the test card to be tested, HbA1c in the sample binds to the antibody coated with fluorescence particles coupled on the glass fiber to form the fluorescence granule-antibody-antigen complex. The immune complex is then chromatographed along the nitric acid cellulose membrane to the detection are (T) an combined with the pre-coated rat anti-hba1c monoclonal antibody. The fluorescence intensity is directly proportional to the content of HbA1c in the sample. The remaining of fluorescence antibody particles were chromatography to the quality control area (C) and combined with the pre-coated sheep anti-rat IgG.

Method:

Fluorescence Immunoassay

Assay Time: 15 min

Sample Volume: 4ul

Sample Type: Whole blood

Technical parameters:

Analytical Sensitivity: 2%

Measuring Range: 2-14%L

Precision: CV≤15%

Accuracy: Relative deviation does not exceed ±15%

Stability: Stable up to 18 months if stored at 2 - 30°C in its sealed pouch.

STORAGE AND STABILITY:

The strip is stable for 18months (while sealed in an aluminum foil pouch) if stored at 2 ° C - 30 ° C. Do not freeze After the strip is opened, the test should be performed in 1 hour.

The date of manufacture is detailed in the label.

Package:

25 pieces/box

Applicable POCT Analyzer

D-10, D-20, KHF01