作者：
江征;朱文慧;朱秀娟;刘桂秀;刘婷;李长贵;
中文关键词：
脊髓灰质炎灭活疫苗;;Sabin株;;D抗原;;ELISA法;;标准化;;国际协作
中文摘要：
目的探讨Sabin株脊髓灰质炎灭活疫苗(inactivated poliomyelitis vaccine prepared with Sabin strain,sIPV)D抗原含量检测标准化的可行性方案。方法采用NIBSC提供的统一检测方法及协作单位的自建方法,分别以野毒株生产的第3代传统脊髓灰质炎灭活疫苗(conventional inactivated poliomyelitis vaccine,cIPV)D抗原国际标准品12/104、第4代cIPV国际标准品替代参考物质08/143和协作单位自建sIPV参考品为协作标准,对不同制造商提供的7个sIPV样品抗原含量进行检测,并比较分析。结果以12/104为协作标准采用统一方法检测sIPV样品的结果实验室间差异最小,采用自建方法检测结果差异最大,且无效试验的比例较高;以sIPV参考品为协作标准时,两种方法的试验有效性和结果的一致性均有所提升。结论建立sIPV专属国际标准品,采用实验室自建方法是sIPV D抗原含量检测国际标准化的最适方案。
英文篇名：
Feasible protocol for standardization of determination of D antigen content in inactivated polio vaccine prepared with Sabin strain
英文作者：
JIANG Zheng;ZHU Wen-hui;ZHU Xiu-juan;LIU Gui-xiu;LIU Ting;LI Chang-gui;National Institutes for Food and Drug Control;
英文摘要：
Objective To explore the feasible protocol for standardization of determination of D antigen content in inactivated poliomyelitis vaccines prepared with Sabin strain(sIPV).Methods The D antigen contents of seven trivalent sIPV samples from different manufacturers as well as the current 3 rd International Standard(IS)12/104 for conventional IPV(cIPV)and the cIPV International Reference 08/143,which was validated as IS replacement,were determined by the routine in-house immunochemical method or a common method(NIBSC reagents).The 12/104,08/143 and in-house reference were included in each assay as the reference for potency calculation.The validity as well as inter-laboratory and intra-laboratory variability were statistically evaluated and compared.Results The highest level of consistency of determination results of D antigen contents by various laboratories were found when a common method and IS12/104 were used.However,a relatively high proportion of invalid assays and large differences between determination results of D antigen contents by various laboratories were found when in-house methods and the 12/104 reference were used.Both assay validity and inter-laboratory variability for in-house methods were improved when a sIPV sample was used as a reference.Conclusion The application of current in-house methods developed in various laboratories by establishing a specific WHO IS for sIPV is the preferred strategy for the international standardization of determination of D antigen content of sIPV.
英文关键词：
Inactivated polio vaccine;;Sabin strain;;D antigen;;ELISA;;Standardization;;International cooperation
