人甲胎蛋白第2代国际标准品协作标定研究  

An International Collaborative Calibration Study of the 2 nd WHO International Standard for Alpha-fetoprotein

作　　者：于婷[1] 曲守方[1] YU Ting;QU Shoufang(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》2025年第3期599-603,共5页Labeled Immunoassays and Clinical Medicine

基　　金：广东省社会发展科技协同创新项目(编号:2023A1111120024)。

摘　　要：目的对人甲胎蛋白(alpha-fetoprotein,AFP)第2代国际标准品(编号:22/216)的含量进行协作标定研究。方法中国食品药品检定研究院代表中国实验室,组织了13家AFP试剂生产企业,采用13种化学发光免疫分析法、2种时间分辨荧光免疫法和1种酶联免疫法的试剂盒,按照英国药品和健康产品管理局提供的统一研究方案,以AFP第1代国际标准品为标准标定22/216。结果中国实验室提交的22/216含量的几何平均值(geometric mean,GM)为7828.78IU/安瓿(95%CI:7462.49~8213.05IU/安瓿),其几何变异系数(geometric coefficient of variation,GCV)为9.77%(n=16)。全球4个国家9个实验室参加了本研究,全部数据得到的22/216含量GM为7756.21IU/安瓿(95%CI:7486.81~8035.30IU/安瓿),GCV为8.73%(n=24)。结论经世界卫生组织生物标准专家委员会审核,确定22/216可作为AFP第2代国际标准品使用,效价为7800IU/安瓿。Objective To conduct a collaborative calibration study on the content of the 2 nd international standard for human alpha-fetoprotein(AFP)(code:22/216).Methods According to the research protocol of Medicines and Healthcare Products Regulatory Agency,National Institutes for Food and Drug Control,on behalf of representative Chinese laboratories,we organized 13 AFP reagent production enterprises to calibrate 22/126 against 1 st AFP international standard,including 13 chemiluminescence immunoassay kits,2 time-resolved fluorescence immunoassay kits,and 1 enzyme-linked immunofluorescence assay kit.Results The geometric mean(GM)of 22/216 content submitted by representative Chinese laboratory was 7828.78 IU/ampoule(95%CI:7462.49-213.05 IU/ampoule),in which the geometric coefficient of variation(GCV)was 9.77%(n=16).All the data from 9 laboratories in 4 countries over the world showed that the 22/216 content GM was 7756.21 IU/ampoule(95%CI:7486.81-8035.30 IU/ampoule)and GCV was 8.73%(n=24).Conclusion After reviewed and approved by the WHO Expert Committee on Biological Standards,it is proposed that 22/216 is successfully established as the 2 nd WHO International Standard for AFP,with 7800 IU/ampoule as the final approved content.

关 键 词：甲胎蛋白 国际标准品 协作标定 化学发光免疫分析法 时间分辨荧光免疫法 酶联免疫法 

分 类 号：R-331[医药卫生]