Abstract

The current coronavirus disease 2019 (COVID-19) outbreak, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a public health emergency of international concern. There has been a surge in demand for COVID-19 diagnostic reagents, as timely detection of virus carriers is one of the most important components of disease prevention and control. Nucleic acid testing (NAT), with high sensitivity and specificity, is considered the “gold standard” for the diagnosis of COVID-19. Therefore, more than 700 research units and companies have been devoted to developing NAT reagents. To date, nearly 600 research units and companies have claimed to have completed the development of NAT reagents. The use of these products has a positive effect on disease prevention and control; however, exaggerated claims and inadequate understanding of the products have led to improper access to reagents and equipment in clinics. This has resulted in chaos in the clinical diagnosis of COVID-19. Herein, we have overviewed the COVID-19 NAT products, including their principles, corresponding advantages and disadvantages, relevant circumstances for application, and respective roles in epidemic containment. Our comments may provide some references for assay developers and aid clinical staff in choosing the appropriate class of test from the different tests available.

摘要

当前由严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 引起的 2019 年冠状病毒病 (COVID-19) 爆发是国际关注的突发公共卫生事件。对 COVID-19 诊断试剂的需求激增，因为及时检测病毒携带者是疾病预防和控制的最重要组成部分之一。核酸检测 (NAT) 具有高灵敏度和特异性，被认为是诊断 COVID-19 的“金标准”。因此，700多个研究单位和公司一直致力于开发NAT试剂。迄今为止，已有近600家科研单位和企业声称已经完成了NAT试剂的研发。使用这些产品对疾病预防和控制有积极作用；然而，夸大的声明和对产品的不充分了解导致在诊所中获取试剂和设备的方式不当。这导致了COVID-19的临床诊断混乱。在此，我们对 COVID-19 NAT 产品进行了概述，包括它们的原理、相应的优缺点、应用的相关情况以及各自在疫情控制中的作用。我们的评论可能会为分析开发人员提供一些参考，并帮助临床工作人员从可用的不同测试中选择合适的测试类别。申请的相关情况，以及各自在疫情防控中的作用。我们的评论可能会为分析开发人员提供一些参考，并帮助临床工作人员从可用的不同测试中选择合适的测试类别。申请的相关情况，以及各自在疫情防控中的作用。我们的评论可能会为分析开发人员提供一些参考，并帮助临床工作人员从可用的不同测试中选择合适的测试类别。