【INTENDED USE】
Anti-HCV ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of antibody to Hepatitis C Virus in human serum or plasma.

【SPECIFIC PERFORMANCE CHARACTERISTICS】

1. Sensitivity

The sensitivity studies have been made on a panel of 738 positive samples. DAAN HCV has presented a 99.8% sensitivity on true HCV positive panels.

2. Specificity

The specificity has been determinated on blood donors samples (2318 samples tested) and on hospitalized patients (348 samples tested). The specificity calculated is 98.9% and 98.5% respectively.

3. Precision

Assay reproducibility was determined by assaying 3 specimens in replicates of 10 on 2 consecutive runs using the same production lot. The Intra-assay and Inter-assay standard deviation (S.D.) and the coefficient of variation (%CV) were calculated (Table I).The mean signal to cut-off ratio (S/CO) is defined as the Mean Sample Absorbance divided by the calculated Cut-Off value.