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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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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
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author Bruijns, Brigitte
Folkertsma, Laura
Tiggelaar, Roald
author_facet Bruijns, Brigitte
Folkertsma, Laura
Tiggelaar, Roald
author_sort Bruijns, Brigitte
collection PubMed
description 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.
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spelling pubmed-91228392022-05-21 FDA authorized molecular point-of-care SARS-CoV-2 tests: A critical review on principles, systems and clinical performances Bruijns, Brigitte Folkertsma, Laura Tiggelaar, Roald Biosens Bioelectron X Article 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. The Author(s). Published by Elsevier B.V. 2022-09 2022-05-21 /pmc/articles/PMC9122839/ /pubmed/35619623 http://dx.doi.org/10.1016/j.biosx.2022.100158 Text en © 2022 The Author(s) Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Bruijns, Brigitte
Folkertsma, Laura
Tiggelaar, Roald
FDA authorized molecular point-of-care SARS-CoV-2 tests: A critical review on principles, systems and clinical performances
title FDA authorized molecular point-of-care SARS-CoV-2 tests: A critical review on principles, systems and clinical performances
title_full FDA authorized molecular point-of-care SARS-CoV-2 tests: A critical review on principles, systems and clinical performances
title_fullStr FDA authorized molecular point-of-care SARS-CoV-2 tests: A critical review on principles, systems and clinical performances
title_full_unstemmed FDA authorized molecular point-of-care SARS-CoV-2 tests: A critical review on principles, systems and clinical performances
title_short FDA authorized molecular point-of-care SARS-CoV-2 tests: A critical review on principles, systems and clinical performances
title_sort fda authorized molecular point-of-care sars-cov-2 tests: a critical review on principles, systems and clinical performances
topic Article
url 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
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