人垂体泌乳素第4次国际标准品协作标定

发布时间：2018-05-12 02:07

本文选题：泌乳素 + 国际标准品　；参考：《药物分析杂志》2017年10期

【摘要】：目的:参与标定人垂体泌乳素(PRL)第4次国际候选标准品(批号83/573),为WHO评估其作为国际标准品的适用性提供数据支持。方法:以第3次PRL国际标准品(批号84/500)为标准,采用放射免疫法、磁微粒酶联免疫法、化学发光免疫法和时间分辨免疫荧光法标定PRL第4次国际候选标准品(批号83/573)。结果:本实验室上报数据:PRL第4次国际候选标准品(批号83/573)免疫效价的几何均值为64.7 m IU·安瓿-1,与WHO报告数据相对偏差为-3.6%。全球10个实验室提交了数据。经标定,PRL第4次国际候选标准品(批号:83/573)的免疫效价几何均值为67.2 m IU·安瓿-1,且稳定性和均匀性满足要求。结论:经WHO生物标准专家委员会审核通过,最终确定PRL候选品(批号:83/573)可作为第4次人垂体源PRL国际标准品使用,每安瓿效价定为67 m IU。
[Abstract]:Aim: to evaluate the applicability of human pituitary prolactin (PRL) as an international standard for WHO evaluation by participating in the fourth international candidate standard (lot number 83 / 573). Methods: using the 3rd PRL international standard (batch 84 / 500) as the standard, radioimmunoassay, magnetic particle enzyme-linked immunosorbent assay, chemiluminescence immunoassay and time-resolved immunofluorescence method were used to calibrate the fourth international standard of PRL (lot number 83 / 573). Results: the geometric mean of immunological titer of the fourth international candidate standard product (lot number 83 / 573) was 64.7 Miu ampoul -1, and the relative deviation from WHO data was -3.6%. Data were submitted by 10 laboratories around the world. The geometric mean immunoreaction of the fourth international candidate standard for PRL (batch number: 83 / 573) was 67.2 Miu ampoule -1, and the stability and uniformity met the requirements. Conclusion: the candidate of PRL (batch number: 83 / 573) can be used as the fourth international standard for human pituitary PRL by WHO Biological Standards expert Committee. The titer of PRL is 67 m IU per ampoule.
【作者单位】：中国食品药品检定研究院;
【分类号】：R392-33

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