血源筛查诊断试剂及其质量控制  

Blood screening diagnostic kit and its quality control

作　　者：胡晋君 蔡远远 宋爱京[1] 许四宏[1] HU Jinjun;CAI Yuanyuan;SONG Aijing;XU Sihong(DivisionⅡof Diagnostic Kits for Infectious Diseases,National Institutes for Food and Drug Control,Beijing 100050,China;National Vaccine&Serum Institute,Beijing 100176,China)

机构地区：[1]中国食品药品检定研究院传染病诊断试剂二室,北京100050 [2]北京生物制品研究所,北京100176

出　　处：《中国药品标准》2022年第2期138-143,共6页Drug Standards of China

摘　　要：血源筛查试剂,指用于血源筛查的体外诊断试剂,其质量与公共健康密切相关。本文重点关注血筛试剂的种类、监管现状、质量控制、相关标准物质和标准等。Blood screening diagnostic kit refers to the in vitro testing assay kit used for blood source screening,and its quality is closely related to public health.The review focuses on blood screening reagents,regulations,quality control,and requirements/standards.

关 键 词：血筛试剂 质量控制 监管 

分 类 号：R921.2[医药卫生—药学]