【INTENDED USE】
Anti-HBs ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of Anti-HBs in human serum or plasma.

【SPECIFIC PERFORMANCE CHARACTERISTICS】

1. Sensitivity

The sensitivity studies have been evaluated by using the national panel of purified Anti-HBs prepared by National Institute For the Control of Pharmaceutical and Biological Products (China), the minimal concentration of detection was not above 10mIu/ml.

2. Specificity

The specificity has been determinated on blood donors’ samples (9340samples tested) and on hospitalized patients (1325samples tested). The specificity calculated is respectively 100% and 99.16%.

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.