世界卫生组织《传染病核酸或抗原体外诊断试剂二级标准物质研制指南》解读  

Interpretation of WHO manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection

作　　者：王一平[1] 郝晓甜 孙会敏[1] 梁争论[1] 吴星[1] WANG Yiping;HAO Xiaotian;SUN Huimin;LIANG Zhenglun;WU Xing(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：《中国病毒病杂志》2023年第3期165-168,共4页Chinese Journal of Viral Diseases

基　　金：中国医学科学院医学与健康科技创新工程项目(2021-I2M-5-005)。

摘　　要：为满足全球范围对传染病类体外诊断试剂标准物质研制指南的需求,世界卫生组织颁布了《传染病核酸或抗原体外诊断试剂二级标准物质研制指南》,该文件以核酸及抗原作为目标检测物,提出了对该类二级标准物质原材料选择、稳定性研究、协作标定的设计和统计等的具体技术要求。本文对该指南进行解读,对提升我国体外诊断试剂二级标准物质的研制和应用水平,促进传染病诊断试剂发展具有重要参照意义。In order to meet the global demand for guidance on the preparation of reference materials for in vitro diagnostic(IVD)reagents of infectious diseases,the World Health Organization issued WHO manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection.The guideline takes nucleic acid and antigen as target detection materials,specifiying technical requirements for the selection of raw materials,stability study,design and statistics of collaborative calibration.This interpretation of the guideline is of great significance for improving the development and application of secondary standard materials for IVD reagents and promoting the development of diagnostic reagents of infectious diseases.

关 键 词：体外诊断试剂 二级标准物质 互换性 稳定性 协作标定 

分 类 号：R446[医药卫生—诊断学]