The COVID-19 pandemic in the United States created a unique situation where multiple molecular SARS-CoV-2 diagnostic assays rapidly received Emergency Use Authorization by the FDA and were validated by laboratories and utilized clinically, all within a period of a few weeks. We compared the performance of four of these assays that were evaluated for use at our institution: Abbott RealTime m2000 SARS-CoV-2 Assay, DiaSorin Simplexa COVID-19 Direct, Cepheid Xpert Xpress SARS-CoV-2, and Abbott ID NOW COVID-19. Nasopharyngeal and nasal specimens were collected from 88 ED and hospital-admitted patients and tested by the four methods in parallel to compare performance. ID NOW performance stood out as significantly worse than the other 3 assays despite demonstrating comparable analytic sensitivity. Further study determined that the use of a nasal swab compared to a nylon flocked nasopharyngeal swab, as well as use in a population chronically vs. acutely positive for SARS-CoV-2, were substantial factors.

在美国，COVID-19大流行创造了一种独特的情况，即在短短几周内，多种分子SARS-CoV-2诊断测定迅速获得了FDA的紧急使用授权，并得到了实验室的验证和临床使用。我们比较了在我们机构中评估使用的其中四种测定的性能：雅培RealTime m2000 SARS-CoV-2测定，DiaSorin Simplexa COVID-19 Direct，造父变星Xpert Xpress SARS-CoV-2和雅培ID NOW COVID- 19 收集88例急诊科和住院患者的鼻咽和鼻标本，并通过四种方法并行测试以比较其性能。尽管证明了相当的分析灵敏度，但ID NOW的性能仍显着低于其他3种检测方法。