化学发光微粒子免疫检测法和实时荧光RT-PCR法检测甲型肝炎病毒的比较分析  

Comparison of Two Methods for Detecting Hepatitis A Virus in Human Sera-chemiluminescence Immunoassay and Real-time RT-PCR Assay

作　　者：麻丽丹 何平[2] 王青 李莉[4] 郭雨时 高世光 卢福荣 于洋 MA Li-dan;HE Ping;WANG Qing;LI Li;GUO Yu-shi;GAO Shi-guang;LU Fu-rong;YU Yang(Dandong Entry-Exit Inspection&Quarantine Bureau,Dandong 118000,China;China National Accreditation Center for Conformity Assessment,Beijing 100062,China;Donggang Entry-Exit Inspection&Quarantine Bureau,Dandong 118300,China;Liaoning Entry-Exit Inspection&Quarantine Bureau,Dalian 116000,China)

机构地区：[1]丹东出入境检验检疫局,辽宁丹东118000 [2]中国合格评定国家认可中心,北京100062 [3]东港出入境检验检疫局,辽宁丹东118300 [4]辽宁出入境检验检疫局,辽宁大连116000

出　　处：《辽宁大学学报（自然科学版）》2018年第1期64-70,共7页Journal of Liaoning University：Natural Sciences Edition

摘　　要：目的:比较化学发光微粒子免疫检测法(CMIA)和实时荧光RT-PCR法对218份人血清中甲型肝炎病毒的检测结果.方法:选取2016年8月~2016年11月辽宁省丹东市传染病医院住院患者的血清样本218份,采用CMIA法和实时荧光RT-PCR法检测甲型肝炎病毒,同时对采用实时荧光RT-PCR法的ISO/TS15216-2、FDA-BAM、GB/T 22287-2008三个标准检测甲型肝炎病毒的引物和探针组合进行了比较分析.结果:化学发光微粒子免疫检测法的阳性检出例数为3例,其S/CO值分别为2.22、4.15、1.31.ISO/TS 15216-2、FDA-BAM、GB/T 22287-2008三种实时荧光RT-PCR法的阳性检出例数分别为7例、5例和4例.而CM IA法和实时荧光RT-PCR法有2个阳性样本的检测结果一致,测序的BLAST比对结果表明CM IA法1个阳性样本为假阳性结果,5个CMIA法阴性样本为假阴性结果.结论:ISO方法的实时荧光RT-PCR法用于人血清中甲型肝炎病毒的检测,准确度及灵敏度最佳.Objective To compare the result of ARCHITECT HAVAb-IgM assay and real-time PCR method for detection of 218 hepatitis A virus(HAV)in human sera.Methods Two methods,chemiluminescence immunoassay(CIA)and real-time RT-PCR assay for detecting hepatitis A virus(HAV)in human sera were compared,and primer and probe combinations of ISO/TS 15216-2,FDA-BAM,GB/T 22287-2008 were compared too.218 sera samples collected in hospital from August to November 2014 were analyzed.Results An automated CMIA kit for anti-HAV IgM-Architect was used,and 3 samples were considered reactive,with the signal/cut-off(S/CO)2.22,4.15,and 1.31 respectively.The real-time RT-PCR results showed that there was some agreement among the three PCR groups,and 7,5 and 4 positive sera were observed in the ISO,FDA and GB group,respectively.Compared comprehensively,there were 2 accordant samples between the CMIA and PCR assay,and 1 sample was false positivity with the CIA test,and 5 samples were false negative with the CMIA test.Conclusion ISO-based method for real-time RT-PCR method for the detection of human serum accuracy and sensitivity of the hepatitis A virus is the best.

关 键 词：甲型肝炎病毒 人血清 实时荧光RT-PCR法 化学发光微粒子免疫检测法 

分 类 号：R185[医药卫生—流行病学]