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FDA authorized molecular point-of-care SARS-CoV-2 tests: A critical review on principles, systems and clinical performances

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. Food and Drug Administration for point-of-care or over the counter use. In this review, the working principle of these tests is described as well as t...

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Detalles Bibliográficos
Autores principales: Bruijns, Brigitte, Folkertsma, Laura, Tiggelaar, Roald
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Author(s). Published by Elsevier B.V. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9122839/
https://www.ncbi.nlm.nih.gov/pubmed/35619623
http://dx.doi.org/10.1016/j.biosx.2022.100158
Descripción
Sumario: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. Food and Drug Administration for point-of-care or over the counter use. In this review, the working principle of these tests is described as well as the relevant characteristics (e.g. time-to-result and specimen type). The analytical (e.g. analytical sensitivity) and clinical performance (positive and negative percent agreement) and useability characteristics (e.g. cost, reusability and throughput) of these tests are compared and critically reviewed. Also details for relevant respiratory multiplex assays of these 10 manufacturers are discussed. 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. 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.