Evaluation and Analysis on Performance Verification Methodology of HBsAg

[Objective]To evaluate and analyze the performance verification methodology and experimental methods of HBsAg.[Methods]HBsAg weak positive serum of controlled specified by Clinical Laboratory Centre of Ministry of Health was used. The serum was prepared at the threshold concentration of +20% and -20%,and then were detected to establish their own laboratories threshold concentration. HBsAg weak positive serum of controlled was detected for continuous 20 days,then the s/co value and CV were calculated. Accorded rate of positive and negative was calculated by using quality control material of EQA to detect HBsAg.[Results]The critical value of HBsAg qualitative test was 0.55 IU/ml; all accorded rates of positive and negative were 100%; HBsAg:CV≤11.42%.[Conclusion] HBsAg qualitative test can satisfies the requirements of clinic,with simple evaluation program. The difference of critical value between manufacturer given and the actual indicates that the index provided by manufacturer can not be directly quoted,and the clinical laboratory should establish their own index.