In December 2019 the first case of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was reported in Wuhan, Hubei Province, China ( Lu et al., 2020). The Xpert Xpress has been thoroughly investigated and good performance has been reported, whereas ID NOW is also well-represented in literature, but has relatively low sensitivity. Critical review of scientific literature on these authorized tests revealed that for many of these tests publications are almost or completely absent, with the exception of two systems. Also details for relevant respiratory multiplex assays of these 10 manufacturers are discussed. cost, reusability and throughput) of these tests are compared and critically reviewed. analytical sensitivity) and clinical performance (positive and negative percent agreement) and useability characteristics (e.g. In this review, the working principle of these tests is described as well as the relevant characteristics (e.g.
Food and Drug Administration for point-of-care or over the counter use.
Since the start of the COVID-19 pandemic, 10 manufacturers of molecular tests for SARS-CoV-2 have received Emergency Use Authorizations from the U.S.
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