rhTSH第一次生物测定用国际标准品国际合作研究

在回顾了促甲状腺素(TSH)国际标准品建立和发展历史的基础上,报告了重组人促甲状腺素(rhTSH)第一次生物测定用国际标准品(03/192)国际协作研究的情况.基于在本次协作研究中03/192在不同的分析系统中表现的适当的一致性和其热加速降解品表现的稳定性,世界卫生组织(WHO)已推荐重组制剂03/192作为rhTSH第一次生物测定用国际标准品使用,并定义为9.5 IU/安瓿.本实验室用5种不同的标记免疫分析方法参加协作研究,并对TSH免疫测定用国家标准品(150530-0312)进行了评估,以WHO提供的几支TSH国际标准物质为对照品综合评价TSH免疫测定用国家标准品,其标定结果是0.557 mIU/安瓿,相当于现标示值(0.600 mIU/安瓿)的92.8%,说明TSH国家标准品与国际标准品相符.

Intemational Collaborative Study on the Preparation of 1st International Standard for rhTSH for Bioassay

The history of the international collaborative studies on the preparation of standards of TSH for bioassay and immunoassay was reviewed. The result of collaborative study on the 1^st international standard for thyroid - stimulating hormone, recombinant, human, for bioassay was reported in detail in this article. Based on the results of this collaborative study, it is proposed that the candidate standard be established as the international standard for rhTSH for bloassay, and be assigned an activity of 9.5 IU per ampoule. The national standard preparation of TSH for immunoassay was also reassayed, revealing the potency to be 0. 557 mIU/ampoule, i.e. 92. 8% of the labelled value of 0. 600mIU/ampoule, a reasonable consistency.