利用入境人员血清盘评价西尼罗病毒IgG抗体检测试剂盒  

Evaluation of a Self-prepared Anti-WNV-IgG Diagnostic ELISA Kit with a Panel of Serum Samples Collected from the People from Areas in which West Nile Fever is Endemic

作　　者：王玉春[1,2] 邵强[1] 张丽萍[2] 甄维[2] 吴学敏[2,3] 马雪征[2] 赵勇[2,4] 胡孔新[2] 

机构地区：[1]河南师范大学生命科学学院,新乡453007 [2]中国检验检疫科学研究院,北京100123 [3]温州医科大学,温州325000 [4]吉林大学,长春130000

出　　处：《病毒学报》2014年第5期549-553,共5页Chinese Journal of Virology

基　　金：国家传染病科技重大专项(2013ZX10004805-008);国家传染病科技重大专项(2013ZX10004101-006);中国检科院基本科研项目(2014JK008)

摘　　要：鉴于国内尚无明确的西尼罗病毒(West nile virus,WNV)感染病例报道,通过建立入境人员血清样品盘来评价自行研制西尼罗病毒IgG抗体的间接ELISA检测试剂盒。选择来自WNV感染区的入境人员血清286份,通过美国食品药物管理局(Food and drug administration,FDA)认证的FOCUS公司的West Nile Virus IgG Dxselect试剂盒以及Panbio公司的Dengue IgG Capture ELISA试剂盒筛选出评价用血清样品盘,平行比较评估自行研制的WNV IgG检测试剂盒结果,进一步对试剂盒的特异性,重复性和稳定性进行评价研究。结果显示,自行研制的试剂盒阳性检出率为35.6%,FOCUS West Nile Virus IgG Dxselect检测试剂盒则为32.5%,两者之间无统计学差异(χ2=3.05,P=0.078>0.05),并具有良好的一致性(Kappa=0.837 2);其中两者的阳性检出符合率为91.18%,阴性符合率为95.34%,总符合率为92.66%。研制的间接ELISA方法诊断试剂盒具有良好的特异性,稳定性和敏感性,检测效果与境外权威认证的商品化试剂盒基本一致,为我国防控西尼罗病毒等外来传染病入境提供技术储备,也为尚未传入的传染病免疫试剂盒评价方法提供了参考依据。In view of that there is no report of west Nile virus infection cases in our country, evaluation the self-prepared anti-WNV-IgG diagnostic ELISA kit should be employed with the establishment of the serum sample panel collected from the entry personnel. All individuals of entry personnel were traveled from epi- demic area of infectious west Nile disease. In our study, the serum samples were both detected by self-pre- pared anti-WNV-IgG diagnostic ELISA kit and the FDA certified kits ,which are FOCUS West Nile Virus IgG Dxselect and Panbio Dengue IgG Capture ELISA kits. The self-prepared kit and FDA certified kits were compared and assessed simultaneously. Furthermore, the specificity, repeatability and stability of the kits were also evaluated. The results indicated that no significant difference of detective rates （35.6% for self-prepared kit vs. 32.5% for FOCUS kit, Z2 =3.05,P〉0.05） and good consistency （Kappa=0. 8372） between the self-prepared kit and FDA certified kits. Also, the positive coincidence rate, the negative co- incidence rate and the total coincidence rate were calculated as 91.18%, 95.34% and 92.66% ,respective- ly. The laboratory self-developed kit presented similar quality as the counterpart kits with FDA certificate. The development of our self-prepared anti-WNV-IgG diagnostic ELISA kit will provide technicalsupport for the prevention and control of west Nile virus entry.

关 键 词：间接ELISA法 西尼罗病毒 入境人员 

分 类 号：R373.9[医药卫生—病原生物学]