基于ISO/TS 5798国际标准对新冠病毒核酸检测设计开发及质量控制考虑要点的解析  

Analysis of consideration on design,development and quality control of detection of SARS-CoV-2 by nucleic acid amplification methods based on ISO/TS 5798

作　　者：佟乐[1] 孙巍[1] 杨亚莉[1] 刘东来[1] 郭世富[1] 杨振[1] TONG Yue;SUN Wei;YANG Ya-li;LIU Dong-lai;CUO Shi-fu;YANG Zhen(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《药物分析杂志》2023年第5期902-907,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：设计、开发和建立可接受且高质量SARS-CoV-2核酸检测方法是疫情精准防控的重要保障,研究表明,SARS-CoV-2核酸检测前的样本采集、运输、储存、核酸提取以及检测中核酸扩增方法的选择和试验设计等是影响其准确性的关键因素。在检测方法和试剂盒的开发和日常应用过程中,应进一步明确这些环节的综合质量评价指标。本文基于核酸扩增法检测SARS-CoV-2的原理,结合SARS-CoV-2分子检测的整个流程,对照ISO发布的关于《核酸扩增法检测SARS-CoV-2的要求及建议》,梳理了在SARS-CoV-2核酸检测设计开发及质量控制的关键要点,以期为我国设计开发出更高质量的核酸检测试剂和进一步提高核酸检测质量提供参考。The design,development and establishment of acceptable and high-quality severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)diagnostics based on nucleic acid detection methods is the important guarantee for the precise prevention and control of the epidemic of COVID-19.Studies had shown sample collection,transportation,storage,nucleic acid extraction during the pre-examination work process as well as selection and design of nucleic acid amplification method for detection were key factors affecting the accuracy of COVID-19 nucleic acid detection.In the development and routine application of test methods and kits,the comprehensive quality evaluation indexes of these processes should be further clarified.Based on the principle of SARS-CoV-2 detection by nucleic acid amplification as well as the whole process of SARS-CoV-2 molecular testing,the key points in the design,development and quality control of SARS-CoV-2 nucleic acid detection were summarized according to the“Requirements and recommendations for detection of SARS-CoV-2 by nucleic acid amplification methods”issued by the ISO.It can provide references for design of higher quality nucleic acid testing reagents and further improve the quality of nucleic acid testing in China.

关 键 词：ISO 新冠病毒 核酸扩增法检测 体外诊断试剂 准确性 国际标准 设计开发 质量控制 质量评价 

分 类 号：R917[医药卫生—药物分析学]