游离前列腺特异性抗原第2次国际标准品协作标定  

An International Collaborative Study of the Proposed 2^nd WHO International Standard for Free Prostate Specific Antigen

作　　者：于婷[1] 孙楠[1] 曲守方[1] 孙晶 杨振[1] YU Ting;SUN Nan;QU Shoufang;SUN Jing;YANG Zhen(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《标记免疫分析与临床》2020年第9期1605-1609,1626,共6页Labeled Immunoassays and Clinical Medicine

摘　　要：目的参加游离前列腺特异性抗原(free prostate specific antigen,free PSA)第2次国际标准品候选品(批号:17/102)的协作标定。方法按照世界卫生组织(WHO)研究方案,采用多种化学发光法、时间分辨免疫荧光法、酶联免疫荧光法和流式荧光发光法进行标定。结果全球8个国家10个实验室提交了数据。经标定,free PSA第2次国际标准品候选品的免疫效价几何均值为0.545μg/安瓿(95%置信区间0.508~0.586μg/安瓿,n=21,GCV 17.0%),稳健均值为0.533μg/安瓿;且稳定性和均匀性满足要求。本实验室提交的免疫效价几何均值为0.547μg/安瓿(95%置信区间0.480~0.624μg/安瓿,n=10,GCV 20.1%),与WHO总结数据的相对偏差仅为0.4%。结论经WHO生物标准专家委员会审核通过,最终确定候选品(17/102)可作为第2次free PSA国际标准品使用,每安瓿效价定为0.53μg。Objective To participate in the collaborative calibration of the proposed 2nd international candidate standard for free prostate specific antigen(free PSA),lot No.17/102.Methods According to the World Health Organization(WHO)study protocol,the assays were calibrated by several chemiluminescence immunoassays,time-resolved fluoroimmunometric assay,enzyme linked fluorescent assay and flowcytometry fluorescence luminance assay.Results Ten laboratories in eight countries submitted data.The geometric mean of the laboratory estimates for the proposed 2nd international candidate standard for free PSA,lot No.17/102,was 0.545μg per ampoule(95%CI 0.508-0.586,n=21,GCV 17.0%)with a robust mean of 0.533μg per ampoule.The homogeneity and stability of the candidate standard met the requirements to serve as an IS.The geometric means of immunoreactivity was 0.547μg per ampoule(95%CI 0.480-0.624,n=10,GCV 20.1%)by our laboratory,with a relative standard deviation only 0.4%from the data summarized in WHO report.Conclusion It is proposed by WHO Expert Committee on Biological Standardization that the candidate preparation in ampoule coded,lot No.17/102 is proved as the 2nd IS for free PSA for immunoassay with an assigned content of 0.53μg per ampoule.

关 键 词：游离前列腺特异性抗原 国际标准品 协作标定 化学发光法 时间分辨免疫荧光法 酶联免疫荧光法 流式荧光发光法 

分 类 号：R446.19[医药卫生—诊断学]