第三代抗-HCVELISA试剂盒抗干扰能力分析

Antiturbulent effect of the third-generation anti-HCV ELISA kits

目的 了解目前国内用于抗-HCV检测的第三代ELISA试验盒抗干扰能力之间的差异.方法 使用四家国产和一家进口抗-HCV ELISA试剂盒检测,结果呈阳性的样本均用HCV BLOT（免疫转印）检测确认,并对.HCV BLOT测定不确定的样本用RT-PCR方法测定HCVRNA.结果 对所选择的可能存在干扰物质的268份样本,五家ELISA试剂盒测定的假阳性率为0.37%～12.68%.不同厂家的测定结果之间有较大程度的不一致性,随机两家试剂组合,可使假阳性率降至0～2.2%（P＜0.01）.结论 目前国内使用的第三代抗-HCV ELISA试剂盒在抗干扰能力方面差异明显.因此,对抗-HCV初检阳性的标本,应使用不同于初检试剂的国产或进口试剂盒进行复检,条件许可则可用HCV BLOT予以确认.

Objective To determine antiturbulent effect of the third-generation anti-HCV ELISA kit. Methods Anti-HCV ELISA kits from domestic and foreign manufacturer were used to detect the samles. Thost samples with positive results obtained using different anti-HCV ELISA kits from five manufacturers were further tested by HCV BLOT to determine which result would be true. Then RT-PCR would be done on the samples with anti-HCV ＂Indeterminate＂ by HCV BLOT. Results False positive rate of five kinds of anti-HCV ELISA kits on 268 selected weak positive samples were 0.37 % - 12.68 %. The results from different anti-HCV ELISA kits showed markedly inconsistent. If any two kinds were combined to detect the samples, the false positive rates declined 0- 2.2 % （P 〈 0.01 ）. Conclusions The samples which are positive for anti-HCV detected primarily by a kind of the third-generation ELISA kit must be retested by another domestic or foreign anti-HCV ELISA kits and is better tested by HCV BLOT.