我国柯萨奇病毒A组16型抗原标准品的协作标定和适用性研究  

Collaborative study on calibration and applicability of national antigen standard for coxsackievirus A16 vaccine

作　　者：毛群颖[1] 高帆[1] 王泽鋆 李秀玲 高强[4] 安文琪 杨二霞 卞莲莲[1] 杜瑞晓 崔博沛 徐苗[1] 梁争论[1] MAO Qun-ying;GAO Fan;WANG Ze-jun;LI Xiu-ling;GAO qiang;AN Wen-qi;YANG Er-xia;BIAN Lian-lian;DU Rui-xiao;CUI Bo-pei;XU Miao;LIANG Zheng-lun(Institute for the Control of Biological Products,National Institutes for Food and Drug Control,Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院卫生部生物技术产品检定方法及其标准化重点实验室,北京102629 [2]武汉生物制品研究所有限责任公司,湖北武汉430207 [3]国药中生生物技术研究院有限公司,北京101111 [4]北京科兴生物制品有限公司,北京100085 [5]华兰生物工程股份有限公司,河南新乡453003 [6]江苏康淮生物科技有限公司,江苏泰州225300

出　　处：《中国病毒病杂志》2018年第6期481-486,共6页Chinese Journal of Viral Diseases

基　　金：国家“十三五”科技重大专项课题(2016ZX09101120)

摘　　要：目的建立第一代国家柯萨奇病毒A组16型(CV-A16)抗原标准品,用于CV-A16疫苗的抗原含量检测.方法由中国食品药品检定研究院(中检院)牵头,联合我国主要的CV-A16灭活疫苗研发单位,共计6个实验室,采用协标试剂盒,分别对两个相同、编盲设置的候选CV-A16抗原标准品(A、B)进行CV-A16抗原含量协作标定.并且分别采用各实验室建立的CV-A16抗原检测试剂盒和各自工艺制备的CV-A16疫苗原液,以候选标准品为标准进行适用性研究.结果各实验室A/B相对抗原含量比为0.978~1.082(CV:6.2%~12.4%),表明各实验室检测结果准确、可靠.故将A、B结果合并分析.候选标准品(A、B)的几何均值为2194.5kU/ml,几何变异系数(geometric coefficient of variation,GCV)为11.0%,且协标结果呈正态分布,符合标准品研制要求.将候选标准品的抗原含量暂定为2000U/ml进行适用性研究,共3家实验室完成该研究,结果显示3个采用各自工艺制备的CV-A16原液,在各自建立的CV-A16检测试剂盒上均与候选标准品具有良好的线性和平行性,适用性良好.结论建立的候选标准品可作为CV-A16抗原标准品,赋值为2000U/ml,用于CV-A16疫苗的抗原含量检测.Objective To establish the first national coxsackievirus A16(CV-A16)antigen standard and ensure the reliability of CV-A16 antigen assay for CV-A16 vaccine. Methods Organized by the National Institutes for Food and Drug Control(NIFDC),a collaborative calibration was conducted by NIFDC and other five main CV-A16 inactivated vaccine research and development laboratories in China.Two blind samples(A and B)from one batch of CV-A16 inactivated vaccine were calibrated by CV-A16 antigen content assay with the same CVA16 antigen content detection kit as the candidate standard,and an applicability study for this candidate standard was conducted with the CV-A16 vaccine bulk produced by the same company using self-made CV-A16 antigen detection kit. Results The average relative antigen content of A/B in each laboratory was 0.978-1.082(CV:6.2%~12.4%),indicating that results from different laboratories were accurate and reliable.Therefore,the results of A and B were combined for analyses.The geometric mean of the candidate standard products(A &B)was 2 194.5 kU/ml,and geometric coefficient of variation(GCV)was 11.0%.The results of each laboratory were normally distributed,meeting the development requirements of the standard product.The candidate standard was used as the standard at 2 000 U/ml in the applicability study,and the good linearity and parallelism were found using every CV-A16 antigen produced by each participating laboratory with its own CV-A16 detection kit,respectively.The candidate standard shows high applicability on CV-A16 antigen detection. Conclusions The established candidate standard,assignment of 2 000 U/ml,can be applied as the first national CV-A16 antigen standard for CV-A16 vaccine antigen detection.

关 键 词：手足口病 柯萨奇病毒A组16型 抗原含量 标准品 

分 类 号：R373.2[医药卫生—病原生物学]