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.
作者
谢静
张莹
XIE Jing;ZHANG Ying(Shanghai Food and Drug Administration Certification and Review Center, Shanghai 200020, China)
出处
《上海医药》
CAS
2019年第13期43-44,64,共3页
Shanghai Medical & Pharmaceutical Journal
关键词
校准品
量值传递
溯源
不确定度
calibration product
value transfer
traceability
uncertainty