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A brief performance evaluation and literature review of Abbott ID Now COVID-19 rapid molecular-based test

The qualitative ID Now COVID-19 assay combines claimed performance and ease of use that seem to position it as a reliable test for urgent patient management. However, the declared limit of detection (LOD) of 125 genome equivalents/mL is not confirmed by the published studies, which observed a range...

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Autores principales: Aupaix, Antoine, Lazarova, Elena, Chemais, Monia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier B.V. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8452348/
https://www.ncbi.nlm.nih.gov/pubmed/34555430
http://dx.doi.org/10.1016/j.jviromet.2021.114293
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author Aupaix, Antoine
Lazarova, Elena
Chemais, Monia
author_facet Aupaix, Antoine
Lazarova, Elena
Chemais, Monia
author_sort Aupaix, Antoine
collection PubMed
description The qualitative ID Now COVID-19 assay combines claimed performance and ease of use that seem to position it as a reliable test for urgent patient management. However, the declared limit of detection (LOD) of 125 genome equivalents/mL is not confirmed by the published studies, which observed a range of LOD varying from 276 to 20.000 copies/mL. We decided to establish the LOD value on more robust basis using serial dilutions of a SARS-CoV-2 culture supernatant sample of defined concentration. Afterwards, we tested the analytical performances of the assay with 23 QCMD external quality control measurements. Hence, taking into consideration the additional dilution in the sample receiver cup, we found a lower 95 % LOD of 64 copies/mL. For its intended use and with the new established LOD, ID Now COVID-19 proved to be a suitable test for the diagnosis of COVID-19 in contagious patients, as proposed by the latest Belgian recommendations.
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spelling pubmed-84523482021-09-21 A brief performance evaluation and literature review of Abbott ID Now COVID-19 rapid molecular-based test Aupaix, Antoine Lazarova, Elena Chemais, Monia J Virol Methods Article The qualitative ID Now COVID-19 assay combines claimed performance and ease of use that seem to position it as a reliable test for urgent patient management. However, the declared limit of detection (LOD) of 125 genome equivalents/mL is not confirmed by the published studies, which observed a range of LOD varying from 276 to 20.000 copies/mL. We decided to establish the LOD value on more robust basis using serial dilutions of a SARS-CoV-2 culture supernatant sample of defined concentration. Afterwards, we tested the analytical performances of the assay with 23 QCMD external quality control measurements. Hence, taking into consideration the additional dilution in the sample receiver cup, we found a lower 95 % LOD of 64 copies/mL. For its intended use and with the new established LOD, ID Now COVID-19 proved to be a suitable test for the diagnosis of COVID-19 in contagious patients, as proposed by the latest Belgian recommendations. Elsevier B.V. 2021-12 2021-09-20 /pmc/articles/PMC8452348/ /pubmed/34555430 http://dx.doi.org/10.1016/j.jviromet.2021.114293 Text en © 2021 Elsevier B.V. All rights reserved. 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
Aupaix, Antoine
Lazarova, Elena
Chemais, Monia
A brief performance evaluation and literature review of Abbott ID Now COVID-19 rapid molecular-based test
title A brief performance evaluation and literature review of Abbott ID Now COVID-19 rapid molecular-based test
title_full A brief performance evaluation and literature review of Abbott ID Now COVID-19 rapid molecular-based test
title_fullStr A brief performance evaluation and literature review of Abbott ID Now COVID-19 rapid molecular-based test
title_full_unstemmed A brief performance evaluation and literature review of Abbott ID Now COVID-19 rapid molecular-based test
title_short A brief performance evaluation and literature review of Abbott ID Now COVID-19 rapid molecular-based test
title_sort brief performance evaluation and literature review of abbott id now covid-19 rapid molecular-based test
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8452348/
https://www.ncbi.nlm.nih.gov/pubmed/34555430
http://dx.doi.org/10.1016/j.jviromet.2021.114293
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