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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 standardize and evaluate the stability of the human pituitary luteinizing hormone (LH) candidate international standard (lot 81/535) and to provide data support for evaluating the applicability of this candidate as a third international standard. Methods: LH International Standard Candidate (batch No. 81/552) was analyzed by radioimmunoassay, enzyme-linked immunosorbent assay, chemiluminescence immunoassay and time-resolved immunofluorescence with the second LH international standard (batch number 80/552) 535) potency and stability. RESULTS: The laboratory reported data: The geometric mean of LH (lot 81/535) titer was 34.2 IU · ampoules (-1), equivalent to 103.0% of the data provided in the WHO report; and the stability of sample B The geometric mean of the titers of 26F for 26 years and for sample F for 26 years at 4 ℃ were 24.8 IU · ampoule and 32.4 IU · ampoule respectively. Conclusion: Data were submitted by 11 laboratories worldwide. After calibration, LH (81/535) titer was 33.2 IU · ampoule (-1) (95% confidence limit was 32.1-34.3 IU · ampoule (-1)) and the stability was satisfactory. Approved by the WHO Expert Committee on Biological Standards, the final determination 81/535 can be used as the third LH international standard, the titer per ampule is 33IU.