Joyce Nicole, Seim Lynsey, Smerina Michael
Assistant Professor of Medicine, Hospital Internal Medicine, Mayo Clinic, Jacksonville, FL, USA.
Case Rep Med. 2021 May 22;2021:6688303. doi: 10.1155/2021/6688303. eCollection 2021.
The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is estimated to have affected 6.2 million people in the United States and 27.5 million people worldwide as of September 9, 2020. On February 2, 2020, the Secretary of the Department of Health and Human Services (HHS) determined that the public health emergency justified the development and emergency use of "in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19" by activating the Emergency Use Authorization (EUA) authority under section 564 of the Federal Food, Drug, and Cosmetic Act. Unfortunately, effective mitigation efforts were thwarted early in the outbreak resulting in an expansion of the initial EUA on February 29, 2020, to improve accessibility to in vitro diagnostic testing. Expectantly, the development and deployment of SARS-CoV-2 testing including RT-PCR expanded rapidly in the weeks following the EUA expansion. These newly developed and approved SARS-CoV-2 RT-PCR tests boast impressive positive and negative agreement rates nearing 100%. Despite the exceptionally high rates of agreement, caution is advised as the RT-PCR tests approved under the COVID-19 EUA are in vitro analyses developed with samples artificially doped with SARS-CoV-2 RNA. These tests therefore do not have clinically applicable sensitivity and specificity because they lack a "gold standard" for diagnosis. Here we present three challenging cases requiring cautious interpretation of the newest generation of RT-PCR molecular detection assays, highlighting the major challenges faced by providers treating patients potentially infected with SARS-CoV-2.
截至2020年9月9日，由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引起的新冠疫情估计已在美国影响了620万人，在全球影响了2750万人。2020年2月2日，美国卫生与公众服务部（HHS）部长认定，公共卫生紧急情况证明通过启用《联邦食品、药品和化妆品法案》第564条规定的紧急使用授权（EUA）来开发和紧急使用“用于检测和/或诊断导致新冠的病毒的体外诊断方法”是合理的。不幸的是，有效的缓解措施在疫情初期就受到了阻碍，导致2020年2月29日对最初的EUA进行了扩展，以提高体外诊断检测的可及性。不出所料，在EUA扩展后的几周内，包括逆转录聚合酶链反应（RT-PCR）在内的SARS-CoV-2检测的开发和部署迅速扩大。这些新开发并获批的SARS-CoV-2 RT-PCR检测的阳性和阴性符合率令人印象深刻，接近100%。尽管符合率极高，但仍需谨慎，因为根据新冠EUA获批的RT-PCR检测是使用人工掺入SARS-CoV-2 RNA的样本进行开发的体外分析方法。因此，这些检测没有临床适用的敏感性和特异性，因为它们缺乏诊断的“金标准”。在此，我们展示了三个具有挑战性的病例，需要对最新一代的RT-PCR分子检测分析进行谨慎解读，突出了治疗可能感染SARS-CoV-2患者的医疗服务提供者所面临的主要挑战。
