酶联免疫吸附法测定破伤风人免疫球蛋白效价的试验研究  

Experimental study of potency assays of human tetanus immunoglobulin by ELISA

作　　者：张华捷[1] 顾磊[1] 赵建荣[1] 吕慧贤[1] 侯启明[1] 张庶民[1] 

机构地区：[1]中国食品药品检定研究院血清室卫生部生物技术产品检定方法及其标准化重点实验室,北京100050

出　　处：《药物分析杂志》2012年第10期1722-1725,1717,共5页Chinese Journal of Pharmaceutical Analysis

基　　金："艾滋病和病毒性肝炎等重大传染病防治"国家科技重大专项(课题编号:2009ZX10004-804)

摘　　要：目的:为建立破伤风人免疫球蛋白(HTIG)效价测定的动物替代方法奠定基础。方法:选取7家企业生产的9批HTIG待检品,分别用酶联免疫吸附法(ELISA)和小鼠毒素中和试验法(TNT)测定其效价,并对2种方法检测结果的一致性进行评价。结果:ELISA法测定结果的回收率达到95%～105%,RSD在10%以内,配对t检验、直线回归和Bland-Altman分析表明ELISA法与TNT法的检测结果具有良好的一致性和相关性。结论:为ELISA法替代TNT法用于HTIG效价测定提供了数据支持。Objective：To provide a basis for establishment of an alternative method to the animal tests for potency assay of human tetanus immunoglobulin（HTIG）.Methods：Nine lots of HTIG final products from seven manufacturers were selected for testing.Potency assays were conducted by enzyme-linked immunosorbent assay（ELISA） and mice toxin neutralization test（TNT）,respectively.The results of the two methods were then evaluated for consistency.Results：The recovery rate of ELISA was 95%-105%,and the RSD was below 10%.Good consistency and relation of ELISA and TNT method was shown by paired t-test,linear regression and Bland-Altman analysis.Conclusion：Our results support the replacement of TNT method in HTIG potency assay by ELISA.

关 键 词：破伤风人免疫球蛋白 被动免疫制剂 效价测定 酶联免疫吸附 毒素中和试验 ELISA法与TNT法一致性 

分 类 号：R917[医药卫生—药物分析学]