摘要目的 应用丙型肝炎病毒抗体确证试验检测肝病患者血清抗HCV,进一步确认HCV感染.方法 对北京万泰生物药业股份有限公司初步研制重组免疫印迹法检测抗HCV试剂(简称CWT)与CHIRON RIBA HCV 3.0 Strip Immunoblot Assay进行比较,采用477份血清标本进行检测分析(慢性丙型肝炎病毒感染者血清350份、非甲非戊型肝炎患者血清7份、对照组采用乙型肝炎患者血清30份、戊肝肝炎患者血清30份及正常献血人员血清60份).结果 120份对照组非丙型肝炎患者血清均为抗HCV阴性;350份慢性丙型肝炎病毒感染者血清,国产试剂检出阳性341份,9份不确定;CHIRON RIBA HCV 3.0 SIA试剂检出阳性343份,不确定7份.7份非甲非戊型肝炎患者血清两种试剂检测均为阳性2份,阴性4份,不确定结果1份.两种试剂比较,检测结果一致率为99.16%(473/477),两者有很强的一致性(Kappa=0.98).结论 两种试剂对丙型肝炎病毒抗体的检测方法具有高度的一致性.特别是对于非甲-非戊型肝炎患者中的HCV感染者更有一定的诊断意义.

abstractsObjective To detect anti-HCV in serum of hepatic disease patients by performing the confirmatory test, and further to confirm HCV infection. Methods Two recombinant immunoblot assays (CWT and CHIRON RIBA HCV 3.0 Strip Immunoblot Assay) were used respectively to detect anti-HCV in 477 human serum samples, which comprised 350 HCV-infected patients' specimens, 7 none-A none-E hepatitis specimens, 30 HBV-infected patients' specimens, 30 hepatitis E virus infected patients'specimens, and 60 specimens drawn from blood donors. The latter three groups served as controls. Results A total of 120 control non-HCV-infected patients' specimens were negative when tested by both assays. Among 350 HCV-infected patients, 341 were positive and 9 were indeterminated by CWT assay; 343 were positive and 7 were indeterminated by CHIRON RIBA HCV 3. 0 SIA. Seven none-A none-E hepatitis specimens tested by both assays turned out to be 2 positive, 4 negative and 1 indeterminate. The consistency rate of these two assays was 99. 16% (Kappa=0.98). Conclusion CWT assay is highly coherent with CHIRON RIBA HCV 3.0 SIA assay in the methodology of anti-HCV antibody detection, which can be applied in the determination of HCV infection among none-A none-E hepatitis patients.