对全球首个新型冠状病毒核酸检测国际标准ISO/TS 5798:2022中通用要求的分析及研究

Research and Analysis on the General Requirements of ISO/TS 5798:2022-the First International Standard for Nucleic Acid Testing of COVID-19

国际标准化组织(ISO)于2022年4月19日发布全球首个专门针对新型冠状病毒核酸检测的国际标准——ISO/TS 5798:2022《体外诊断检验系统——核酸扩增法检测新型冠状病毒(SARSCoV-2)的要求及建议》。本文对该标准通用要求部分进行分析及研究,并与我国2021年11月26日发布的GB/T 40982—2021《新型冠状病毒核酸检测试剂盒质量评价要求》进行比对,以期为我国体外诊断试剂开发、制造单位,以及SARS-CoV-2研究和诊断机构提供参考。

The first international standard specifically for nucleic acid testing of COVID-19—In vitro diagnostic test systems-Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)by nucleic acid amplification methods(ISO/TS 5798:2022)was published by International Organization for Standardization(ISO)on April 19,2022.This paper analyzes and researches on the general requirements of ISO/TS 5798:2022,and compares it with the Quality assessment requirements for severe acute respiratory syndrome coronavirus 2 nucleic acid detection kit(GB/T 40982—2021)released on November 26,2021.This paper aims to provide reference for the in vitro diagnostic developers and manufacturers,as well as institutions and organizations supporting SARS-CoV-2 research and diagnostics in China.