【INTENDED USE】
HBsAg ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of Hepatitis B Surface Antigen(HBsAg) in human serum or plasma.

【SPECIFIC PERFORMANCE CHARACTERISTICS】

1. Sensitivity

The sensitivity studies have been evaluated by using the national panel of purified HBsAg prepared by National Institute For the Control of Pharmaceutical and Biological Products (China), the minimal concentration of detection was not above 0.5 ng/ml.

2. Specificity

The specificity has been determinated on blood donors’ samples (11083 samples tested) and on hospitalized patients (1580 samples tested). The specificity calculated is respectively 100% and 99.87%.

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.