摘要
随着体外诊断(In Vitro Diagnostic,IVD)检测技术的快速发展,检测分析物种类越来越多,能够给临床提供更多的辅助诊断信息,体外诊断试剂已经成为医疗机构非常重要的一部分。定量类体外诊断试剂需要满足溯源标准化,分析性能可靠,参考区间合理等条件,才能达到临床要求。文章简要介绍参考区间建立与验证的原则、方法以及已上市产品存在的问题,为以后同类产品注册提供帮助。
With the rapid development of in vitro diagnostic testing technology,there are more and more kinds of analytes,which can provide more auxiliary diagnostic information for clinic.In vitro diagnostic reagents have become a very important part of medical institutions.Quantitative in vitro diagnostic reagents need to meet the conditions of traceability standardization,reliable analytical performance and reasonable reference interval in order to meet the clinical requirements.This paper briefly introduces the principles,methods and problems existing in the establishment and verification of reference interval,so as to provide help for the registration of similar products in the future.
作者
陈慧毅
董劲春
CHEN Hui-yi;DONG Jin-chun(Center for Medical Device Evaluation,NMPA,Beijing 100081)
出处
《中国医疗器械信息》
2021年第17期7-8,共2页
China Medical Device Information
关键词
体外诊断
参考区间
建立与验证
IVD
reference interval
establishment and verification
