利用RIBA试验确定HCV抗体检测的cut-off值及比较分析  

An Evaluation of the Anti-Hepatitis C Virus Antibody Cut-Off Values with the Recombinant Immunoblot Assay Test

作　　者：陈陆[1] 徐东[1] 宋玉杰[1] 石磊 李英 曹正 翟燕红[1] CHEN Lu;XU Dong;SONG Yujie;SHI Lei;LI Ying;CAO Zheng;ZHAI Yanhong(Department of Laboratory Medicine,Beijing Obstetrics and Gynecology Hospital,Capital Medical University,Beijing Maternal and Child Health Care Hospital,Beijing 100026,China;Cancer Hospital,Chinese Academy of Medical Sciences,Beijing 100021,China)

机构地区：[1]首都医科大学附属北京妇产医院/北京妇幼保健院,北京100026 [2]中国医学科学院肿瘤医院,北京100021

出　　处：《标记免疫分析与临床》2022年第9期1465-1468,共4页Labeled Immunoassays and Clinical Medicine

基　　金：北京市属医院科研培育计划项目(编号:PX2020060)。

摘　　要：目的利用重组蛋白免疫印迹分析(RIBA)实验,制定本实验室所用的日本希森美康公司的HISCL-5000型化学发光免疫分析仪及配套的相关试剂检测丙型肝炎病毒抗体(抗-HCV)的cut-off值。方法在2015年10月至2016年9月所检测的19341例患者标本中收集抗-HCV阳性标本80例,进行RIBA确认实验后进行分析,再利用ROC曲线计算出cut-off值。结果在本室HCV抗体阳性率为0.41%的数据中,RIBA结果可分为3种,其中25例(31.3%)为阴性,18例(22.5%)为不确定,37例(46.2%)为阳性。当截断值为3.95 COI时,灵敏度为81.1%,特异性为95.1%。另外当特异性为100%时,截断值为5.25 COI,灵敏度为73%。结论希森美康HISCL-5000型化学发光免疫分析仪及配套的相关试剂检测丙型肝炎病毒抗体(抗-HCV)与RIBA结果间呈正相关;当cut-off值为3.95 COI时,是一个适合本实验室的cut-off值。Objective Based on the recombinant immunoblot assay(RIBA)hepatitis C virus(HCV)test results,we aim to evaluate the cut-off values with SYSMEX HISCL-5000 automated immunochemiluminescent platform and SYSMEX recomLine HCV IgG reagent.Methods A total of 80 HCV-IgG positive serum samples were retained from the screening population of 19341 subjects from October,2015 to September,2016.These positive serum samples were subsequently subjected to RIBA HCV test for confirmation.Receiver operating characteristic(ROC)curve and proper statistical analysis were then applied.Results Of 80 subjects tested by RIBA assay,25(31.3%)were tested negative,18(22.5%)were tested uncertain and 37(46.2%)were tested positive.With cut-off value of 3.95 COI obtained,the sensitivity was 81.1%and the specificity was 95.1%.When the specificity was set at 100%,with cut-off value of 5.25 COI,the sensitivity was 73.0%.Conclusion It’s necessary to setup the laboratory’s own cut-off value of the anti-HCV IgG immunoassay in HCV screening,depending on the clinical needs and applications.

关 键 词：HCV抗体检测 希森美康HISCL-5000 RIBA试验 CUT-OFF值 

分 类 号：R392-33[医药卫生—免疫学]