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Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department

BACKGROUND: Rapid testing for COVID-19 has been clearly identified as an essential component of the strategy to control the SARS-CoV-2 epidemic, worldwide. The ID NOW COVID-19 assay is a simple, user-friendly, rapid molecular biology test based on nicking and extension amplification reaction (NEAR)....

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Autores principales: NguyenVan, Jean-Claude, Gerlier, Camille, Pilmis, Benoît, Mizrahi, Assaf, Péan de Ponfilly, Gauthier, Khaterchi, Amir, Enouf, Vincent, Ganansia, Olivier, Le Monnier, Alban
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier B.V. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8556064/
https://www.ncbi.nlm.nih.gov/pubmed/34768231
http://dx.doi.org/10.1016/j.jcv.2021.105021
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author NguyenVan, Jean-Claude
Gerlier, Camille
Pilmis, Benoît
Mizrahi, Assaf
Péan de Ponfilly, Gauthier
Khaterchi, Amir
Enouf, Vincent
Ganansia, Olivier
Le Monnier, Alban
author_facet NguyenVan, Jean-Claude
Gerlier, Camille
Pilmis, Benoît
Mizrahi, Assaf
Péan de Ponfilly, Gauthier
Khaterchi, Amir
Enouf, Vincent
Ganansia, Olivier
Le Monnier, Alban
author_sort NguyenVan, Jean-Claude
collection PubMed
description BACKGROUND: Rapid testing for COVID-19 has been clearly identified as an essential component of the strategy to control the SARS-CoV-2 epidemic, worldwide. The ID NOW COVID-19 assay is a simple, user-friendly, rapid molecular biology test based on nicking and extension amplification reaction (NEAR). OBJECTIVES: The aim of this study was to evaluate the ID NOW COVID-19 assay when used as a point-of-care test (POCT) in our Emergency Department (ED). TYPE OF STUDY: This prospective study enrolled 395 consecutive patients; paired nasopharyngeal swabs were collected from each study participant. The first swab was tested with the ID NOW COVID-19 assay at the point-of-care by ED nurses. The second swab was diluted in viral transport medium (VTM) and sent to the clinical microbiology department for analysis by both the RT-PCR Simplexa test COVID-19 Direct assay as the study reference method, and the ID NOW COVID-19 assay performed in the laboratory. RESULTS: Nasopharyngeal swabs directly tested with the ID NOW COVID-19 assay yielded a sensitivity, specificity, PPV and NPV of 98.0%, 97.5%, 96.2% and 98.7%, respectively, in comparison with the RT-PCR study reference assay. When the ID NOW COVID-19 assay was performed in the laboratory using the VTM samples, the sensitivity decreased to 62.5% and the NPV to 79.7%. Three false negative test results were reported with the ID NOW COVID-19 assay when performed using undiluted swabs directly in the ED; these results were obtained from patients with elevated CT values (> 30). CONCLUSION: We demonstrated that the ID NOW COVID-19 assay, performed as a point of care test in the ED using dry swabs, provides a rapid and reliable alternative to laboratory-based RT-PCR methods
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spelling pubmed-85560642021-11-01 Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department NguyenVan, Jean-Claude Gerlier, Camille Pilmis, Benoît Mizrahi, Assaf Péan de Ponfilly, Gauthier Khaterchi, Amir Enouf, Vincent Ganansia, Olivier Le Monnier, Alban J Clin Virol Article BACKGROUND: Rapid testing for COVID-19 has been clearly identified as an essential component of the strategy to control the SARS-CoV-2 epidemic, worldwide. The ID NOW COVID-19 assay is a simple, user-friendly, rapid molecular biology test based on nicking and extension amplification reaction (NEAR). OBJECTIVES: The aim of this study was to evaluate the ID NOW COVID-19 assay when used as a point-of-care test (POCT) in our Emergency Department (ED). TYPE OF STUDY: This prospective study enrolled 395 consecutive patients; paired nasopharyngeal swabs were collected from each study participant. The first swab was tested with the ID NOW COVID-19 assay at the point-of-care by ED nurses. The second swab was diluted in viral transport medium (VTM) and sent to the clinical microbiology department for analysis by both the RT-PCR Simplexa test COVID-19 Direct assay as the study reference method, and the ID NOW COVID-19 assay performed in the laboratory. RESULTS: Nasopharyngeal swabs directly tested with the ID NOW COVID-19 assay yielded a sensitivity, specificity, PPV and NPV of 98.0%, 97.5%, 96.2% and 98.7%, respectively, in comparison with the RT-PCR study reference assay. When the ID NOW COVID-19 assay was performed in the laboratory using the VTM samples, the sensitivity decreased to 62.5% and the NPV to 79.7%. Three false negative test results were reported with the ID NOW COVID-19 assay when performed using undiluted swabs directly in the ED; these results were obtained from patients with elevated CT values (> 30). CONCLUSION: We demonstrated that the ID NOW COVID-19 assay, performed as a point of care test in the ED using dry swabs, provides a rapid and reliable alternative to laboratory-based RT-PCR methods Elsevier B.V. 2021-12 2021-10-30 /pmc/articles/PMC8556064/ /pubmed/34768231 http://dx.doi.org/10.1016/j.jcv.2021.105021 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
NguyenVan, Jean-Claude
Gerlier, Camille
Pilmis, Benoît
Mizrahi, Assaf
Péan de Ponfilly, Gauthier
Khaterchi, Amir
Enouf, Vincent
Ganansia, Olivier
Le Monnier, Alban
Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department
title Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department
title_full Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department
title_fullStr Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department
title_full_unstemmed Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department
title_short Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department
title_sort prospective evaluation of id now covid-19 assay used as point-of-care test in an emergency department
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8556064/
https://www.ncbi.nlm.nih.gov/pubmed/34768231
http://dx.doi.org/10.1016/j.jcv.2021.105021
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