国产与进口RIBA试剂试验结果分析及随访研究  

Follow up study of domestic and imported HCV RIBA assay in anti-HCV positive blood donors

作　　者：王立林[1] 孙元璋 龙洁萍 孙亚纯 崔秀娟[1] 陈云龙[1] 邬林枫[1] 杜丹丹[1] 曾劲峰[1] 杨宝成[1] 

机构地区：[1]深圳市血液中心,广东深圳518035

出　　处：《中国输血杂志》2016年第12期1336-1339,共4页Chinese Journal of Blood Transfusion

基　　金：深圳市科技创新委员会项目(JCYJ20140403093211510);深圳市卫生计生系统科研项目(201401074)

摘　　要：目的在抗-HCV阳性献血者中,以进口重组免疫印迹试剂为参考,分析国产丙型肝炎病毒重组免疫印迹试验作为补充试验的质量差异。方法对107例抗-HCV阳性献血者血液标本,补充进口及国产2种重组免疫印迹试剂检测,不一致标本进行随访研究,参考进口重组免疫印迹试剂检测结果,分析国产重组免疫印迹试剂作为抗-HCV阳性献血者补充试验的意义。结果国产重组免疫印迹试剂阳性率50.47%(54/107),进口重组免疫印迹试剂阳性率60.75%(65/107)。国产重组免疫印迹试剂灵敏度83.87%,特异度71.88%,两者相关性强(Spearman相关系数rs=0.645,P<0.01),Kappa检验2种试剂盒检测结果一致性中等(Kappa=0.599,P<0.001),配对χ2检验2种重组免疫印迹试剂差异有统计学意义(Mc Nemar-Bowker,P<0.05)。对2种重组免疫印迹试验不一致献血者中6人进行随访,HCV RNA核酸定性检测均为阴性,抗-HCV检测2例阳性,国产重组免疫印迹试验均为阴性,进口重组免疫印迹试验3例阳性,2例可疑,1例阴性。结论国产重组免疫印迹试剂在灵敏度与特异度上接近进口重组免疫印迹试剂,但仍有进一步提升改进空间。Objective To evaluate the domestic recombinant immunoblot assay and its potential value in anti-HCV pos- itive blood donors. Methods A total of 107 anti-HCV positive samples were tested by domestic and imported RIBA. An a- nalysis was conducted on two complementary experiments and a follow up study was used to evaluate their values for applica- tion. Results The positive detective rate of domestic RIBA was 50.47% （54/107）, and 60.75% （65/107） of imported RIBA. Based on the detection of anti-HCV antibodies by imported RIBA, the sensitivity of domestic RIBA was 83.87%, the specificity was 71.88%. There were good correlation between domestic and imported RIBA （Spearman rs = 0. 645, P〈0.01 ）. The Kappa statistic for results of two RIBA assays was 0. 599, indicating moderate concordance （ P〈0. 001 ）. The McNe-mar- Bowker test revealed a poor agreement between domestic and imported RIBA （P〈0. 05）. Six donors with discrepant samples were followed up. No HCV RNA yield was detected by NAT. Two were positive for anti-HCV positive, while all the six sam- pies were tested negative by domestic RIBA, but three were tested positive, two undetermined and one negative by imported RIBA. Conclusion Although domestic RIBA reagent is only slightly inferior to imported R1BA in sensitivity and specificity, it still presents more challenge for further improvement.

关 键 词：RIBA HCV 随访研究 临界值指数 核酸检测 

分 类 号：R457.1[医药卫生—治疗学] R446.62[医药卫生—临床医学]