乙肝病毒表面抗原可疑阳性标本确认方法的建立

目的 建立基于酶联免疫吸附试验（ELISA）的乙肝病毒表面抗原（HBsAg）确认方法，避免错误诊断。方法收集ELISA检测HBsAb〉15COI的血清，取HBsAb阳性；HBsAb、HBeAb、HBcAb阳性；HBsAb、HBcAb阳性三种模式的血清各20份混合，与HBsAgELISA结果浓度〉20COI的血清中和以确认HBsAb的中和活性，制成确认试剂。确认试剂与30例HBsAg弱阳性阳性患者血清中和，HBsAgCOI下降率〉50％判定为阳性，其结果与罗氏确认试剂盒进行比对。结果确认试剂可以很好的中和HBsAg，对30例HBsAg弱阳性标本的判定结果为24例阳性，6例阴性，与罗氏确认试剂盒结果完全一致。结论成功建立HBsAg确认方法，适用于对HBsAg弱阳性样本进行确认，并且简单经济。

Establishment of confirmatory test for suspicious hepatitis B surface antigen positive samples

Objective Establish a confirmatory test based on ELISA, and use to verify the authenticity of HBsAg weak positive samples, pick and get rid of the false result, and avoid the mistake diagnosis. Method The particles （reagent A） coated by streptavidin and biotinylated HBsAb （reagent B） were mixed in different proportions, then neutralized with serum whose the COI of HBsAg 〉 20 by ELISA in order to identify the activity of HBsAb in confirmatory reagent. 30 pieces of HBsAg weak positive serum neutralized with the confirmatory reagent, the serum were considered to be positive if rate of decline of HBsAg COI〉 50%. The results were compared to Roche confirmatory Kit. Result Confirmatory reagent was able to neutralized with HBsAg. 24 of 30 pieces of HBsAg weak positive samples were judged to be positive, while 6 poeces were negative. The ELISA comfirm method is fully consistent with Roche confirmatory Kit. Conclusion The ELISA confirmatory test for suspicious HBsAg positive samples is a simple, accurate and low cost initial validation method, After further clinical trials, should be widely applied.