HBsAg和HBsAb双阳性乙肝患者血清中HBsAb确认方法的建立

Establishment of confirmatory test for HBsAb in serum of coexistence of hepatitis B surface antigen and antibodies to HBsAg

目的 建立一种基于酶联免疫吸附实验（ ELISA）的HBsAb确认方法,验证HBsAg和HBsAb双阳性的乙肝患者血清中HBsAb阳性的真实性,剔除假阳性结果,避免错误诊断.方法收集60例电化学发光免疫分析法（ ECLIA）检测的HBsAg浓度在1000 COI以上的混合血清作为确认血清,将不同稀释度的确认血清与收集的HBsAb阳性混合血清中和,筛选并确定确认血清中HBsAg的最佳试验浓度.收集40例HBsAg和HBsAb双阳性的血清,与确认血清中和后采用ELISA检测COI的下降率,验证HBsAg和HBsAb双阳性标本中HBsAb阳性的真实性.结果 确认血清HBsAg浓度为2000 COI时对HBsAb的中和效果最好,ELISA确认法对40例HBsAg和HBsAb双阳性标本确认结果为37例真阳性和3例假阳性,与ECLIA法完全一致.结论 成功建立了HBsAg和HBsAb双阳性血清HBsAb的确认方法,该方法简单、准确且成本较低.

Objective Establish a kind of confirmation method based on ELISA,and use to verify authenticity of HBsAb ＋ in HBsAg ＋ HBsAb ＋ serum,pick and get rid of the false masculine gender the result,and avoid the mistake diagnosis.Method Collect 60 pieces of serum whose thick degree of H BsAg at 1000 COI above tested by ECLIA as confirm serum,mixed the confirm serum of different dilution with HBsAb positive serum to screen and verify best thick degree of HBsAg.Collected 40 pieces of HBsAg ＋ HBsAb ＋serum,ELISA tested the descend rate of HBsAb COI after neutralized with confirm serum in order to confirm authenticity of HBsAb ＋ in pieces of HBsAg ＋ HBsAb ＋ serum.Result When thick degree of HBsAg is 2000 COI,the performance of neutralization to HBsAb is best.The ELISA confirmatory test is fully consistent with the ECLIA method with true positive of 37 pieces of HBsAg ＋ HBsAb ＋ serum while falsepositive of 3 pieces of serum.Conclusion The ELISA confirm method is a simple,accurate and low cost initial validation method.