人垂体促黄体生成激素第3次国际标准品协作标定研究

International collaborative study of the proposed 3^(rd) international standard for human pituitary luteinizing hormone

目的:标定并评价人垂体促黄体生成激素(LH)国际候选标准品(批号81/535)的稳定性,为WHO评估该候选品作为第3次国际标准品的适用性提供数据支持。方法:以第2次LH国际标准品(批号80/552)为标准品,采用放射免疫法、酶联免疫法、化学发光免疫法和时间分辨免疫荧光法分析LH国际候选标准品(批号81/535)的效价和稳定性。结果:本实验室上报数据:LH(批号81/535)效价的几何均数为34.2 IU·安瓿^(-1),相当于WHO报告中提供数据的103.0%;稳定性样本B(37℃放置26年)和样本F(4℃放置26年)效价的几何均数分别为24.8 IU·安瓿^(-1)和32.4 IU·安瓿^(-1)。结论:全球11个实验室提交了数据。经标定,LH(81/535)效价为33.2IU·安瓿^(-1)(95%可信限为32.1~34.3 IU·安瓿^(-1)),且稳定性满足要求。经WHO生物标准专家委员会审核通过,最终确定81/535可作为第3次LH国际标准品使用,每安瓿效价定为33IU。

Objective： To calibrate and assess the suitability of international candidate standard for human pituitary luteinizing hormone （ LH ）, lot No. 81/535, and to provide data support for the applicability of candidate as 3r＇3 international standard. Methods： The assay and stability of LH international candidate standard, lot No. 81/535, were tested by radioimmunoassay, enzyme-linked immunosorbent assay; chemiluminescence immunoassay and time-resolved fluoroimmunometric assay using the 2nd IS （ LH, lot No. 80/552 ） as reference standard. Results： The geometric means of immunoreactivity for LH, lot No. 81/535, was 34.2 IU per ampoule by our laboratory, which was corresponding to 103.0% of those provided in WHO report. The geometric means of immunoreactivity for stability samples B （ 26 years, 37 ℃ ） and sample F （ 26 years, 4 ℃ ） were 24.8 IU per ampoule and 32.4 IU per ampoule,respectively. Conclusion： Eleven laboratories around the world presented data. The geometric mean of the laboratory estimates of the LH immunoreactivity of the candidate standard, coded 81/535, is 33.2 IU per ampoule （ 95% confidence limits 32.1 IUper ampoule-34.3IU per ampoule ）with acceptable stability data. It is proposed by WHO Expert Committee on Biological Standardization that the candidate preparation in ampoules coded, lot No. 81/535 can be used as the 3rd IS for Human Pituitary LH for immunoassay with an assigned content of 33 IU LH per ampoule.