中国15群钩端螺旋体代表菌株分群血清参考品的研制  

Development of typing antiserum references for fifteen Chinese representative Leptospira strains

作　　者：徐颖华[1] 李喆[1] 张影[1] 杜宗利 辛晓芳[1] 叶强[1] XU Ying-hua;LI Zhe;ZHANG Ying;DU Zong-li;XIN Xiao-fang;YE Qiang(National Institutes for Food and Drug Control,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

出　　处：《中国生物制品学杂志》2018年第9期974-976,共3页Chinese Journal of Biologicals

基　　金：国家自然科学基金项目(81401249);科技部重大新药创制课题(2013ZX09304101)

摘　　要：目的研制中国15群钩端螺旋体代表菌株的分群血清参考品。方法制备1批冻干钩端螺旋体15群候选分群参考血清,与国内15株代表菌株进行显微镜凝集试验,同时组织协作标定,并对冻干候选制剂进行稳定性分析。结果冻干的血清候选参考品外观色泽均匀、形态饱满,水分含量均<3%。每个协作实验室检测结果的室内和室间变异系数(CV)均低于15%。各血清候选参考品于-20℃保存24个月的抗体滴度与协作标定及于-20℃保存12个月的结果差异无统计学意义(P>0.05)。结论研制的中国15群钩端螺旋体代表菌株分群血清参考品具有良好的稳定性,可用于钩体菌株血清分群和菌体疫苗鉴别试验。Objective To develop the typing antiserum references for fifteen Chinese representative Leptospira strains.Methods A batch of freeze-dried candidate reference for fifteen Chinese representative Leptospira strains was prepared,and subjected to microscopic agglutination with fifteen Chinese representative Leptospira strains. A collaborative calibration was organized,and the stability of freeze-dried candidate reference was analyzed. Results The freeze-dried antiserum references showed uniform shape and lustre,of which the moisture content was less than 3%. The inter-and intracoefficients of variation（CV） of test results of various laboratories were less than 15%. The titers of candidate references after storage at-20 ℃ for 24 months showed no significant differences with those in collaborative calibration and those after storage at the same temperature for 12 months（P〉0. 05）. Conclusion The typing antiserum references for fifteen Chinese representative Leptospira strains have been successfully developed,which show high stability and may be used for the serogrouping of Leptospira strains as well as the identity test of whole-cell Leptospira vaccine.

关 键 词：钩端螺旋体 血清参考品 显微镜凝集试验 稳定性 

分 类 号：R377.5[医药卫生—病原生物学] R392-33[医药卫生—基础医学]