HbA1c reagent kit GLY-100 series

monoclonal antibodyfor clinical chemistrycalibration

Quantitative determination of Glycated hemoglobin(HbA1c) in human whole blood. METHODOLOGY This kit is based on latex agglutination. HbA1c in test samples is absorbed onto the surface of latex particles, which react with Anti-HbA1c (antigenantibody reaction). The turbidity caused by latex agglutination is measured at 660 nm, and the HbA1c concentration in whole blood is calculated from a standard curve. REAGENTS R1 : Latex R2 : Anti-HbA1c (Anti-human hemoglobin A1c mouse monoclonal antibody) Sample Diluent : Distilled wWater and stabilizers. CALIBRATION (Optional) For only use bt products (GLYCAL-10) Auto-HbA1c Calibrator Five (5) Level. PRECAUTIONS 1. For only in vitro diagnostic use. 2. Reagent R1 and R2 are light-sensitive. Store in a dark place. 3. Avoid ingestion and contact with skin and eyes. REAGENT PREPARATION All the reagents are ready to use. REAGENT DETERIORATION 1. Do not use the reagents after the expiration date. 2. Increment of blank reagent absorbance. 3. Presence of particles, turbidity. INTERFERENCES High lipid (3000 formazin turbidity units) or bilirubin (conjugated type 30mg/dL, free type 30 mg/dL) counts in blood samples do not affect the test results. ADDITIONAL EQUIPMENT 1. Spectrophotometer or photometer thermo stable at 37˚C with a 660 nm filter. 2. (GLYCAL-10) Auto-HbA1c Calibrator Five (5) Level and (GLYCON-10) Auto- HbA1c Control are recommended. CALIBRATION PROSEDURE Auto- HbA1c calibrator sets are intended for use with Auto- HbA1c assay reagents. Calculate the absorbance difference (Abs.2-Abs.1) of each point of the calibration curve