肠道病毒71型假病毒荧光定量检测方法在疫苗中和抗体检测中的应用  

System Suitability of Pseudovirus Luciferase Assay for the Detection of EV71 Neutralizing Antibody

作　　者：吴星[1] 姚昕[1] 毛群颖[1] 张军楠[1] 邵杰[1] 梁争论[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2014年第2期174-177,共4页Chinese Pharmaceutical Affairs

基　　金：国家"十二五"科技重大专项课题(编号2012ZX10004701)

摘　　要：目的假病毒荧光定量方法 (PVLA)应用于EV71疫苗动物样本和人体样本检测的适用性研究。方法分别采用细胞病变法(CPE)和PVLA方法检测82份EV71试验小鼠血清以及27份疫苗临床试验人体血清样本,比较两者检测的一致性。结果应用两种方法检测82份疫苗免疫小鼠血清,EV71中和抗体滴度的相关系数为0.842,Bland-Altman分析显示高度一致性;检测27份EV71临床试验人体血清样本的中和抗体,两种方法具有高度一致性。结论 PVLA与CPE方法具有高度一致性,适用于疫苗免疫动物样本和临床评价人体样本EV71中和抗体的检测。Objective To evaluate the system suitability of the pseudovirus luciferase assay （PVLA） for the detection of EV71 neutralizing antibody. Methods Serum from experimental animal for the study of EV71 vaccine and samples from EVT1 vaccine clinical trial were tested by these two methods. Results Totally 82 mouse serum samples were analyzed by both methods, the correlation coefficient for EV71 neutralizing antibody titer turned out to be 0. 842, and the Bland-Altman analysis revealed a high consistency. Analysis of neutralizing antibody in 27 EV71 clinical samples using these two methods also gave a high consistency. Conclusion Overall, the results suggested that there is a high consistency between the PVLA and CPE methods, and that PVLAwas a good alternative method for the detection of EV71 neutralizing antibody in both pre-clinical and clinical samples.

关 键 词：肠道病毒71型(EV71) 假病毒 荧光定量 中和抗体 

分 类 号：R927.1[医药卫生—药学] R915