免疫测定用人垂体促甲状腺激素第三次国际参考制剂国际协作标定  

International Collaborative Study on the Proposed 3^(rd) International Reference Preparation of TSH for Immunoassay

作　　者：黄颖[1] 沈洪征[1] 徐立根[1] 李波[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药事》2006年第8期478-483,共6页Chinese Pharmaceutical Affairs

摘　　要：本文报告了在国际协作研究中,以TSH第2次国际参考制剂为对照品,用化学发光免疫分析、酶联免疫分析、放射免疫分析和免疫放射量度分析试剂盒测定TSH 81/565(候选的TSH第3次国际参考制剂)、TSH 81/615和TSH 81/502以及TSH国家标准品的免疫效价。所有免疫分析法结果:TSH81/565、TSH 81/615和TSH 81/502效价的几何均数分别为11.5、11.4和7.38 mIU/安瓿,相当于WHO报告中提供的几何均数的99.1%,101.8%和100.4%;TSH国家标准品与第2次国际参考制剂的相对效价为0.942。然而,在不同的免疫分析方法之间存在一定差异。对TSH 81/565而言,酶联免疫分析法测定的效价的几何均数最小,为8.07/安瓿;而化学发光免疫分析法测定值最大,为12.8/安瓿。双份样品精密性测定:TSH第2次国际参考制剂双份样品之间的相对效价为0.84~1.08,TSH 81/565双份样品之间的相对效价为0.82~1.18。+4℃热加速降解样品测定结果符合WHO报告中所述的免疫活性变化趋势。Immunological potencies of TSH 81/565 （candidate 3rd TSH IRP）, TSH 81/615, TSH 81/ 502 and TSH national standard were assayed respectively by CLIA, ELISA, RIA and IRMA kits with the 2^nd international TSH reference preparation as control in an international collaborative study. The geometric means of the potencies were 11.5, 11.4 and 7.8 mIU/ampoule for TSH 81/565, TSH 81/615 and TSH 81/502 respectively, and were corresponding to 99.1%, 101.8% and 100.4% of those provided in WHO report. The relative potency of national TSH standard to 2na international reference preparation was 0. 942. However, there was some difference between each immunoassay methods. For TSH 81/565, the geometric mean of potency was the smallest when ELISA was used and the biggest while CLIA was used, with the results of 8.07 and 12.8/ampoule respectively. Precision of duplicate showed a relative potency of 0.84-1.08 for 2^nd international reference preparation of TSH and that of 0.82-1.18 for TSH 81/565. Results of accelerated thermal degradation test at 4 ℃ conformed to the trend of immunoactivity change described in WHO report.

关 键 词：促甲状腺激素 国际标准品 国家标准品 化学发光免疫分析 酶联免疫分析 放射免疫分析 免疫放射量度分析 精密性 

分 类 号：R917.794[医药卫生—药物分析学]