摘要
体外诊断试剂标准物质是实现量值溯源、保证检测数据和结果准确一致的重要材料。自上世纪80年代以来,国内实验室在体外诊断试剂标准物质的研制方面做了大量的工作。本文简要介绍了目前国内研制的体外诊断标准物质及其研制中所采用的主要形式:以参考方法、参考系统和标准物质为基础的计量学溯源体系;以多中心合作标定、一致化或类似一致化的溯源体系,并针对两种溯源体系的差别进行了阐述。
Reference materials for in vitro diagnostic reagents are important in achieving the traceability of measurements and guaranteeing the quality of the test data as well as the result. Since the 1980 s,domestic laboratories have done much work in the preparation of reference materials for in vitro diagnostic reagents. This article aims to introduce the reference materials of in vitro diagnostic reagents and its traceability systems： the metrological traceability system, which is based on reference procedures, reference materials, and reference systems; and the homogenization traceability system based on collaborative study to determine the assignment of value to reference materials.
作者
付岳
高旭年
黄杰
FU Yue GAO Xunian HUANG Jie(Beijing Institute of Medical Device Testing, Beijing, China, 101111 Guangzhou Bangdesheng Biological Technology Co., Ltd, Guangdong, Guangzhou, China, 510665 National Institutes for Food and Drug Control, Beijing, China, 100050)
出处
《分子诊断与治疗杂志》
2017年第2期73-77,87,共6页
Journal of Molecular Diagnostics and Therapy
关键词
体外诊断试剂
标准物质
量值溯源
In vitro diagnostic reagents
Reference materials
Traceability of measurements
