体外诊断试剂产品校准品量值传递方法

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英文篇名：Method for the transfer of calibration quality of in vitro diagnostic reagent products 作者：谢静 ; 张莹 英文作者：XIE Jing;ZHANG Ying;Shanghai Food and Drug Administration Certification and Review Center; 关键词：校准品 ; 量值传递 ; 溯源 ; 不确定度 英文关键词：calibration product;;value transfer;;traceability;;uncertainty 中文刊名：SYIY 英文刊名：Shanghai Medical & Pharmaceutical Journal 机构：上海市食品药品监督管理局认证审评中心; 出版日期：2019-07-10 出版单位：上海医药 年：2019 期：v.40;No.530 语种：中文; 页：SYIY201913016 页数：3 CN：13 ISSN：31-1663/R 分类号：46-47+67

摘要

体外诊断试剂检测系统的准确性需要通过校准品不间断的比较链进行量值传递。校准品量值传递的有效性、可靠性是厂商保证其检测结果准确、可追溯、可重复的重要工具,只有严格按照溯源链进行量值传递,才能保证检测系统能提供可靠的、有参考意义的检测结果。
        The accuracy of in vitro diagnostic reagent detection system needs to be transmitted through the continuous comparison chain of calibration products. The validity and reliability of calibration product value transfer is an important tool for manufacturers to ensure that their detection results are accurate, traceable and repeatable. Only when the quantity value is strictly transmitted according to the traceability chain, can the detection system provide reliable and reference test results.

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