国产T_3,T_4,FT_3和FT_4 RIA kit对比测定研究  

Comparison of Results of Radioimmunoassay Performed with NationwideDifferent Commercial Kits for Thyroid Hormones (T_3, T_4, FT_3, FT_4)

作　　者：徐立根[1] 孙有香[1] 焦岩[1] 杨文保 魏泽坤 孙艳民 

机构地区：[1]中国药品生物制品检定所,100050 [2]焦作解放放射免疫诊断试剂研究所,454000

出　　处：《放射免疫学杂志》2005年第1期1-4,共4页Journal of Radioimmanology

摘　　要：目的:使用国家质控血清和临床未知血清样品对国产甲状腺激素放射免疫分析试剂盒进行对比测 定研究。方法:采用放射免疫分析法。结果:测定结果来自本实验室和15个生产商实验室。T3和T4:14组样 品测定均值的变异系数,其中12组在5%～15%之间,2组在15%～20%之间;提示试剂盒之间的可比性好。 FT3:7组样品测定均值的变异系数在25%～45%之间;FT4:7组样品测定均值的变异系数在15%～45%之间; 提示试剂盒之间存在系统误差。结论:本实验提示T3、T4试剂盒质量满意,而FT3、FT4试剂盒的系统误差不容 忽视。Objective Study on an external quality assessment program with national quality control sera as standard for the comparison of the radioimmunoassay results obtained with different kits for thyroid hormones. Methods National quality control sera as well as pooled “unknown” clinical sera specimens were assigned to the national laboratory and different manufactures’ laboratories (n=15) to be assayed for thyroid hormones and the results cross-checked. Results With T 3 and T 4, the coefficient variation (CV) of different sets (n=12) assayed in the national and manafactures’ laboratories ranged from 5~15% (15~20% in other 2 sets only), suggesting good comparability and reproducibility. However, with FT 3 and FT 4, the CV in 7 sets of assays was 25~45% and 15~45% respectively, suggesting the presence of systematic differences. Conclusion Present study revealed fairly satisfactory quality with T 3 and T 4 kits. With FT 3 and FT 4, presence of systematic differences should be taken into consideration and the laboratory data cautiously explained.

关 键 词：FT3 FT4 试剂盒 RIA 样品测定 国产 质控血清 变异系数 测定结果 

分 类 号：R446[医药卫生—诊断学] R581[医药卫生—临床医学]