新冠病毒抗原快速检测试剂的性能及其适用范围

Performance and application scope of rapid detection reagents for SARS-CoV-2 antigen

自新冠肺炎疫情暴发以来,多种检测方法已应用到新冠肺炎诊断,其中核酸检测因具有高度敏感性和特异性而被确定为新冠肺炎诊断的标准方法,但该方法需要在生物安全二级实验室内进行,需要专业设备和人员,难以在实验资源匮乏的社区和现场开展。抗原快速检测方法(Ag-RDT)操作简便、快捷、成本低,可应用于这些场合。世界卫生组织已将Ag-RDT推荐为新冠肺炎早期诊断的辅助手段。目前,Ag-RDT试剂品种繁多,性能各异,在实际应用中存在一定的局限性。本文简要归纳总结Ag-RDT试剂的性能及适用范围,供相关人员参考。

Since the outbreak of COVID-19 epidemic,a variety of detection methods have been applied in COVID-19diagnosis. Nucleic acid detection has been confirmed as the standard diagnostic method for COVID-19 because of its higher sensitivity and specificity. However,this method needs to be performed in BSL-2 laboratory,as well as professional equipment and personnel,it is difficult to carry out in communities and fields where experimental resources are scarce. Antigen rapid diagnostic test(Ag-RDT) has the advantages of simple operation,fast and low cost,which can be applied in these fields. World Health Organization has recommended Ag-RDT as an auxiliary means for early diagnosis of COVID-19. At present,there are many kinds of Ag-RDT reagents with different performance,and there are limitations in practical application. This paper briefly summarized the performance and application scope of Ag-RDT reagents,which can be used as a reference for relevant experts.