胶体金免疫层析试剂盒对甲型H1N1流感病毒(2009)抗原快速检测的敏感性分析  

Sensitivity analysis on colloidal gold immunochromatography assay kit in rapid antigen test of influenza A pandemic (H1N1) 2009 virus

作　　者：田棣[1] 何静[1] 刘祎[1] 张万菊[1] 徐磊[1] 陈功祥[2] 周志统[1] 胡芸文[1] 

机构地区：[1]上海市公共卫生临床中心病原体检测与生物安全部,上海201508 [2]浙江大学附属第二医院临床检验中心,浙江杭州310009

出　　处：《检验医学》2013年第2期154-158,共5页Laboratory Medicine

基　　金：国家十二五"艾滋病和病毒性肝炎等重大传染病防治"科技重大专项(2012ZX10004211);上海市公共卫生临床中心萌芽计划基金项目(2010MY02)

摘　　要：目的了解胶体金免疫层析试剂盒对甲型H1N1流感病毒(2009)抗原快速检测的敏感性。方法分别用甲型流感病毒抗原检测试剂盒(胶体金免疫层析法)和甲型/乙型流感病毒抗原检测试剂盒(胶体金免疫层析法)对171例疑似甲型H1N1流感(2009)患者鼻咽拭子标本进行检测,以实时荧光定量聚合酶链反应(FQ-PCR)核酸检测结果为参考,比较胶体金免疫层析试剂盒对不同病程以及不同病毒核酸载量标本检测的敏感性。结果 2种试剂盒的检测敏感性与标本的病毒核酸载量呈正相关(P<0.01),病毒载量≥108拷贝/mL时均可达73.3%。同时,2种试剂盒的阳性检出率与标本的病程呈负相关(P<0.01),发病1～2 d时分别为66.7%和62.5%,推测其在实际应用中的理论敏感性分别可达77.3%和74.6%。结论胶体金免疫层析试剂盒检测甲型H1N1流感病毒(2009)在发病初期及病毒载量较高时有较好的检测效果,可帮助临床早期诊断和海关口岸等机构的现场筛查。但鉴于胶体金免疫层析法自身的局限性,其结果只能作为初步参考,最终的确认结果应以PCR结果为准。Objective To research the sensitivity of colloidal gold immunochromatography assay kit in rapid antigen test of influenza A pandemic（H1N1） 2009 virus. Methods A total of 171 nasal-pharyngeal swabs were tested retrospectively by the colloidal gold immunochromatography assay kits,and the results determined by real-time fluorescence quantitative polymerase chain reaction（FQ-PCR） were as reference. Compared to the results of real-time FQ-PCR,the sensitivities of the 2 kits were then obtained at various courses of disease and virus RNA concentrations. Results The sensitivities of the 2 kits had significantly positive correlation with virus RNA concentrations（P〈0.01）,and reached both 73.3% when the virus RNA concentration was ≥108 copies/mL. The positive rates of the 2 kits showed significantly negative correlation with the courses of disease（P〈0.01）,and were 66.7% and 62.5% respectively between 1 to 2 d after the symptoms appeared. Theoretical study demonstrated that the sensitivities would be 77.3% and 74.6%. Conclusions The colloidal gold immunochromatography assay kit could provide early diagnostic efficacy of influenza A pandemic（H1N1） 2009 virus,and the feature is high virus concentration. It could be used in early diagnosis and screening test of massive specimens or field test for customs. Since the colloidal gold immunochromatography assay has some limitations,the results of the assay should be confirmed by PCR.

关 键 词：甲型H1N1流感病毒(2009) 抗原快速检测 胶体金免疫层析法 实时荧光定量聚合酶链反应 

分 类 号：R446.5[医药卫生—诊断学]