人垂体泌乳素第4次国际标准品协作标定

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 mIU·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 mIU·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 mIU。

Objective:To calibrate the proposed 4^th international candidate standard for human pituitary prolactin(PRL),lot No.83/573,which will provide data support for WHO to assess the applicability of candidate asinternational standard.Methods:The assay of the proposed 4^th international candidate standard for PRL,lot No.83/573,were calibrated in terms of the 3^rdIS(PRL,lot No.84/500),by radioimmunoassay,immunoenzymetricassay(magnetic solid phase),time-resolved fluoroimmunometric assay and chemiluminescence immunoassay.Results:The geometric means of immunoreactivity for the proposed 4^thinternational candidate standard for PRL,lot No.83/573,was 64.7 mIU per ampoule by our laboratory,relative standard deviation was -3.6% with corresponding to those data provided in WHO report.Ten laboratories around the world submitted data.The geometric mean of the laboratory estimates of the proposed 4^th international candidate standard for PRL,lot No.83/573,was 67.2 mIU per ampoule,and homogeneity,stability meet the requirements.Conclusion:It is proposed by WHO Expert Committee on Biological Standardization that the candidate preparation in ampoules coded,lot No. 83/573 is established as the 4^th IS for prolactin,human,pituitary for immunoassay with an assigned content of 67.2 mIU per ampoule.