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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.

Biosystems Hemoglobin A1C Reagent

CONTENTS AND COMPOSITION

1. 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.

STORAGE

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.

Biosystems Hemoglobin A1C Reagent

AUXILIARY REAGENTS

1. 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.

REAGENT PREPARATION

Reagents are provided ready to use.

ADDITIONAL EQUIPMENT

– Thermostatic water bath at 37ºC.
– Analyzer, spectrophotometer or photometer with cell holder thermostatable at 37ºC and able to read at 670nm.

Biosystems Hemoglobin A1C Reagent SAMPLES

Venous blood collected by standard procedures and with EDTA as anticoagulant.
HbA1C in blood is stable 7 days at 2-8ºC.

Biosystems Hemoglobin A1C Reagent

REFERENCE VALUES

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 patients1,2