应用ROC曲线评价化学发光法及酶联免疫法对HCV感染的诊断价值  

Evaluation of CLIA and ELISA in the diagnosis of HCV infections using ROC curve

作　　者：李锋[1,2] 王菊英[1] 姚琳芳[1] 顾常梅 魏军[1,2] LI Feng WANG Ju-ying YAO Lin-fang GU Chang-mei WEI Jun.(Genral Hospital of Ningxia Medical Uni- versit Key Laboratory of Clinical pathogenic microorganisms of Ningxia, Yinchuan 750004, China)

机构地区：[1]宁夏医科大学总医院医学实验中心 宁夏临床病原微生物重点实验室,宁夏银川750004 [2]宁夏医科大学总医院医学实验中心,宁夏银川750004

出　　处：《国际病毒学杂志》2016年第6期398-400,404,共4页International Journal of Virology

基　　金：宁夏临床病原微生物重点实验室开放课题项目（LCPM201504）

摘　　要：目的 探讨国内五种主流丙型肝炎病毒抗体（抗-HCV）酶联免疫法（ELISA）试剂与进口化学发光法（CLIA）检测性能的可比性及其对HCV感染的诊断价值.方法 应用CLIA及五种ELISA（编号为A、B、C、D、E）,同时检测免疫印迹法（RIBA）确认的抗-HCV阳性、阴性血清样本各68例,应用受试者工作特征曲线（ROC）评价其性能指标.结果 CLIA及A、B、C、D、E五种ELISA试剂ROC曲线下面积（AUC）分别为：0.989、0.784、0.945、0.841、0.890、0.883（P ＜0.05）,差异有统计学意义;CLIA的敏感性大于五种ELISA试剂（P＜0.05）,差异有统计学意义,差异主要在于CLIA 8＞S/CO值≥1标本的符合率较低;几种试剂间特异性无显著性差异（P=0.75）.结论 国内五种主流HCV抗体ELISA试剂与进口CLIA对HCV感染均具有较高的诊断价值,利用CHA高敏感性及ELISA的高特异性联合检测抗-HCV,可提高HCV感染的诊断效率.Objective To discuss the comparability of detection performance between five frequently-used domestic ELISA reagents and an imported CLIA reagent.Methods To detect 68 samples which were positive Anti-HCV confirmed by RIBA with CLIA and ELISA （numbered with A,B,C,D and E） and evaluated the performance parameters of them by ROC curve.Results The areas under the ROC curve of the imported CLIA reagent and five frequently-used domestic ELISA reagents are 0.989,0.784,0.945,0.841,0.890 and 0.883 respectively.In all these groups,the difference was significant.The sensitivity ofCLIA is greater than five kinds of ELISA reagents （P 〈 0.05）,which showed significant difference between each groups （P 〈 0.05）.The difference of sensitivity is mainly due to the low coincidence of the CLIA-Positive samples with 8 〉 S/CO ≥ 1.The specificity between different kits showed no significant difference （P =0.75）.Conclusions All five frequently-used domestic ELISA reagents and an imported CLIA reagent have great diagnostic value in HCV infection.A better diagnostic performance can be achieved by using ELISA and CLIA simultaneously,based on the high sensitivity of CLIA and well sensitivity of ELISA assay.

关 键 词：免疫印迹法 化学发光法 酶联免疫法 ROC曲线 

分 类 号：R195[医药卫生—卫生统计学]