总前列腺特异性抗原第2次国际标准品协作标定  

International collaborative calibration of the proposed 2nd international candidate standard for total prostate specific antigen

作　　者：于婷[1] 孙楠[1] 曲守方[1] 孙晶 杨振[1] 黄杰[1] YU Ting;SUN Nan;QU Shou-fang;SUN Jing;YANG Zhen;HUANG Jie(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：《中国生物制品学杂志》2020年第11期1301-1306,共6页Chinese Journal of Biologicals

基　　金：郑州市重大科技创新专项(2019CXZX0078)。

摘　　要：目的对总前列腺特异性抗原(total prostate specific antigen,total PSA)第2次国际标准品候选品(批号17/100)进行协作标定。方法按照世界卫生组织(WHO)研究方案,采用多种化学发光免疫分析法、酶联免疫荧光法、流式荧光发光法和时间分辨免疫荧光法进行标定。结果全球8个国家10个实验室提交了数据。经标定,total PSA第2次国际标准品候选品的免疫效价几何平均值(geometric mean,GM)为0.514μg/安瓿(95%置信区间0.489~0.542μg/安瓿,n=22,GCV 12.3%),稳健均值为0.505μg/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GM为0.520μg/安瓿(95%置信区间0.474~0.571μg/安瓿,n=11,GCV 14.8%),与WHO总结数据的相对偏差为1.2%。结论经WHO生物标准专家委员会审核通过,确定候选品(批号17/100)可作为第2次total PSA国际标准品使用,每安瓿效价定为0.50μg。Objective To collaboratively calibrate the proposed 2nd international candidate standard for total prostate specific antigen(total PSA,lot No.17/100).Methods According to the World Health Organization(WHO)study protocol,the candidate standard was calibrated by several chemiluminescence immunoassays,enzyme linked fluorescent assay,flow cytometry fluorescence luminance assay and time-resolved fluoroimmunometric assay.Results Ten laboratories in eight countries submitted data.The geometric mean(GM)of the laboratory estimates for the proposed 2nd international candidate standard for total PSA(lot No.17/100)was 0.514μg per container(95%CI 0.489~0.542μg per container,n=22,GCV 12.3%)with a robust mean of 0.505μg per container.The homogeneity and stability of the candidate standard met the requirements for an IS.The GM of immune potency of the proposed 2nd international candidate standard for total PSA(lot No.17/100)submitted by our laboratory was 0.520μg per container(95%CI0.474~0.571μg per container,n=11,GCV 14.8%),with a relative standard deviation of only 1.2%to the data provided in WHO report.Conclusion It is proposed by WHO Expert Committee on Biological Standardization that the candidate standard(lot No.17/100)is established as the 2nd IS for total PSA,of which the potency is assigned as 0.50μg per container.

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

分 类 号：R917[医药卫生—药物分析学]