Anti-TgAb和Anti-TpoAb测定用国家标准品的建立  

Preparation of National Standard Product of Anti-TgAb and Anti-TpoAb in Our Laboratory

作　　者：黄颖[1] 于婷[1] 沈洪征[1] 

机构地区：[1]中国药品生物制品检定所,100050

出　　处：《放射免疫学杂志》2007年第4期352-355,共4页Journal of Radioimmanology

摘　　要：目的:为规范国产Anti-TgAb和Anti-TpoAb定量测定试剂盒,本实验室研制并建立了Anti-TgAb和Anti-TpoAb免疫测定用国家标准品。方法和结果:选择经临床检测Anti-TgAb、Anti-TpoAb高值血清,经离心、过滤等处理后,分装、冻干制成标准品候选品。以WHO Anti-TgAb1st IRP(65/093)为对照品,经协作标定,候选品中Anti-TgAb免疫活性均值为3691IU/支,以WHO Anti-TpoAb RS(66/387)为对照品,经协作标定,候选品中Anti-TpoAb免疫活性均值为434IU/支。结论:本标准品中Anti-TgAb免疫活性定义为4000IU/支,Anti-TpoAb免疫活性定义为430IU/支。本标准品的建立,为国产Anti-TgAb和Anti-TpoAb试剂盒提供了定量依据,本文还对目前国内常用的几种进口Anti-TgAb和Anti-TpoAb定量免疫分析试剂盒进行了比较分析,供临床和检验医生参考。Objoctive To standardize the China - made quantitative immunoassay kits of Anti - TgAb and Anti - TpoAb with a national standdized product of Anti - TgAb and Anti - TpoAb developed in our laboratory. Methods and Results Higher titer Anti - TgAb and Anti - TpoAb serum specimens were pooled and treated with centrifuging and filtering, then freeze - dried and packaged into 2ml anpoules for preparing the national standard candidate. The results of the collaborative study showed that, the immuno - activity of the Anti - TgAb was 3916 IU/Amp in term of the 65/093, and the immuno - activity of the Anti - TpoAb was 434 IU/Amp in term of the 66/387. Conclusion On the basis of the present study, it is proposed that the candidate standard be established as the National Standard for Anti - TgAb and Anti - TpoAb for immunoassay, the immunoactivity of the Anti - TgAb 4000IU/Amp, and that of Anti - TpoAb is 430IU/Amp. A comparative study on the quality of immunoassay kits of Anti - TgAb and Anti - TpoAb by Axsym System, Immulite 1000, Medular Analytics E170, ADVIA Centaur Assay （the most commonly used types in China） is also presented.

关 键 词：抗甲状腺球蛋白抗体 抗甲状腺过氧化物酶抗体 国家标准品 

分 类 号：R581[医药卫生—内分泌]