浅谈新型冠状病毒核酸检测试剂性能分析

A Performance Analysis of Novel Coronavirus Nucleic Acid Reagents

导致新型冠状病毒肺炎简称新冠肺炎的病原体是新型冠状病毒(2019-nCoV)。快速、准确的检测出新型冠状病毒对于控制新冠肺炎疫情至关重要。本文简单讨论了已上市新冠病毒核酸检测试剂在性能分析验证方面的要求,同时分析了此类产品上市后遇到的一些问题,对于后续生产厂家研发试剂提供参考。

The Novel Coronavirus(2019-nCoV)is the pathogen causing novel coronavirus pneumonia.A rapid and accurate detection for novel coronavirus is crucial for controlling the spread of the disease.This paper briefly discusses the requirements of the performance analysis and verification of novel coronavirus nucleic acid detection products,and analyzes potential issues encountered of the listed products,so as to provide a reference for subsequent manufacturers to develop reagents.