Biosystems Hemoglobin A1C Reagent
PRINCIPLE OF THE METHOD
After preparing the hemolysate, the Hemoglobin A1C (HbA1C) concentration is quantified by a
latex turbidimetric assay. The different hemoglobins present in the hemolysate are unspecifically
adsorbed on the latex particles surface in a ratio equivalent to their concentration in the sample.
The addition of an anti-human HbA1C antibody causes agglutination that is proportional to the
concentration of hemoglobin A1C and can be measured by turbidimetry.
CONTENTS AND COMPOSITION
A. Reagent. 1 x 50 mL. Suspension of latex particles, sodium azide 0.95 g/L, pH 8.0.
B. Reagent. 1 x 10 mL. Anti-human HbA1C antibody, stabilizers, pH 6.0.
Store at 2-8ºC.
Reagents are stable until the expiry date shown on the label when stored tightly closed and if
contaminations are prevented during their use.
Indications of deterioration: absorbance of the blank over 0.700 at 670 nm.
S. HbA1C Direct Standards (Cod. 31048). 4 levels for 0.5 mL. Human blood. HbA1C
concentration is given on the label.
Human blood used in the preparation of the standard has been tested and found to be
negative for the presence of antibodies anti-HIV and anti-HCV, as well as for HBs antigen.
However, the standard should be handled cautiously as potentially infectious.
Reconstitute with 0.5 mL of distilled water. Stable for 30 days at 2-8°C.
Reagents are provided ready to use.
Thermostatic water bath at 37ºC.
Analyzer, spectrophotometer or photometer with cell holder thermostatable at 37ºC and able to read at 670
Venous blood collected by standard procedures and with EDTA as anticoagulant.
HbA1C in blood is stable 7 days at 2-8ºC.
The following cut-off points have been established by the Diabetes Control and Complications
Trial Research Group (DCCT) and have been adopted by many countries for a reference
population (Non diabetic) and for the evaluation of the degree blood glucose control in diabetic