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One swab, two tests: Validation of dual SARS-CoV-2 testing on the Abbott ID NOW™

BACKGROUND: Point-of-care tests (POCT) are promising tools to detect SARS-CoV-2 in specific settings. Initial reports suggest the ID NOW™ COVID-19 assay (Abbott Diagnostics Inc, USA) is less sensitive than standard real-time reverse transcription polymerase chain reaction (rRT-PCR) assays. This has...

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Autores principales: Burnes, Laura E, Clark, Shawn T, Sheldrake, Elena, Faheem, Amna, Poon, Betty P, Christie-Holmes, Natasha, Finlay, Laura, Kandel, Christopher, Phan, Michael, Frankland, Caylin, Lau, Trevor, Gubbay, Jonathan B, Corbeil, Antoine, Katz, Kevin, Kozak, Robert A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Authors. Published by Elsevier B.V. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8196482/
https://www.ncbi.nlm.nih.gov/pubmed/34174710
http://dx.doi.org/10.1016/j.jcv.2021.104896
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author Burnes, Laura E
Clark, Shawn T
Sheldrake, Elena
Faheem, Amna
Poon, Betty P
Christie-Holmes, Natasha
Finlay, Laura
Kandel, Christopher
Phan, Michael
Frankland, Caylin
Lau, Trevor
Gubbay, Jonathan B
Corbeil, Antoine
Katz, Kevin
Kozak, Robert A.
author_facet Burnes, Laura E
Clark, Shawn T
Sheldrake, Elena
Faheem, Amna
Poon, Betty P
Christie-Holmes, Natasha
Finlay, Laura
Kandel, Christopher
Phan, Michael
Frankland, Caylin
Lau, Trevor
Gubbay, Jonathan B
Corbeil, Antoine
Katz, Kevin
Kozak, Robert A.
author_sort Burnes, Laura E
collection PubMed
description BACKGROUND: Point-of-care tests (POCT) are promising tools to detect SARS-CoV-2 in specific settings. Initial reports suggest the ID NOW™ COVID-19 assay (Abbott Diagnostics Inc, USA) is less sensitive than standard real-time reverse transcription polymerase chain reaction (rRT-PCR) assays. This has raised concern over false negatives in SARS-CoV-2 POCT. OBJECTIVES: We compared the performance of the ID NOW™ COVID-19 assay to our in-house rRT-PCR assay to assess whether dry swabs used in ID NOW™ testing could be stored in transport media and be re-tested by rRT-PCR for redundancy and to provide material for further investigation. METHODS: Paired respiratory swabs collected from patients at three acute care hospitals were used. One swab in transport media (McMaster Molecular Media (MMM)) was tested for SARS-CoV-2 by a laboratory-developed two-target rRT-PCR assay. The second was stored dry in a sterile container and tested by the ID NOW™ COVID-19 assay. Following ID NOW™ testing, dry swabs were stored in MMM for up to 48 h and re-tested by rRT-PCR. Serially diluted SARS-CoV-2 particles were used to assess the impact of heat inactivation and storage time. RESULTS: Respiratory swabs (n = 343) from 179 individuals were included. Using rRT-PCR results as the comparator, the ID NOW™ COVID-19 assay had positive (PPA) and negative (NPA) percent agreements of 87.0% (95% CI:0.74–0.94) and 99.7% (95% CI:0.98–0.99). Re-tested swabs placed in MMM following ID NOW testing had PPA and NPA of 88.8% (95% CI:0.76–0.95) and 99.7% (95% CI:0.98–0.99), respectively. CONCLUSIONS: Storing spent dry swabs in transport media for redundancy rRT-PCR testing is a potential approach to address possible false negatives with the ID NOW™ COVID-19 assay.
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spelling pubmed-81964822021-06-15 One swab, two tests: Validation of dual SARS-CoV-2 testing on the Abbott ID NOW™ Burnes, Laura E Clark, Shawn T Sheldrake, Elena Faheem, Amna Poon, Betty P Christie-Holmes, Natasha Finlay, Laura Kandel, Christopher Phan, Michael Frankland, Caylin Lau, Trevor Gubbay, Jonathan B Corbeil, Antoine Katz, Kevin Kozak, Robert A. J Clin Virol Article BACKGROUND: Point-of-care tests (POCT) are promising tools to detect SARS-CoV-2 in specific settings. Initial reports suggest the ID NOW™ COVID-19 assay (Abbott Diagnostics Inc, USA) is less sensitive than standard real-time reverse transcription polymerase chain reaction (rRT-PCR) assays. This has raised concern over false negatives in SARS-CoV-2 POCT. OBJECTIVES: We compared the performance of the ID NOW™ COVID-19 assay to our in-house rRT-PCR assay to assess whether dry swabs used in ID NOW™ testing could be stored in transport media and be re-tested by rRT-PCR for redundancy and to provide material for further investigation. METHODS: Paired respiratory swabs collected from patients at three acute care hospitals were used. One swab in transport media (McMaster Molecular Media (MMM)) was tested for SARS-CoV-2 by a laboratory-developed two-target rRT-PCR assay. The second was stored dry in a sterile container and tested by the ID NOW™ COVID-19 assay. Following ID NOW™ testing, dry swabs were stored in MMM for up to 48 h and re-tested by rRT-PCR. Serially diluted SARS-CoV-2 particles were used to assess the impact of heat inactivation and storage time. RESULTS: Respiratory swabs (n = 343) from 179 individuals were included. Using rRT-PCR results as the comparator, the ID NOW™ COVID-19 assay had positive (PPA) and negative (NPA) percent agreements of 87.0% (95% CI:0.74–0.94) and 99.7% (95% CI:0.98–0.99). Re-tested swabs placed in MMM following ID NOW testing had PPA and NPA of 88.8% (95% CI:0.76–0.95) and 99.7% (95% CI:0.98–0.99), respectively. CONCLUSIONS: Storing spent dry swabs in transport media for redundancy rRT-PCR testing is a potential approach to address possible false negatives with the ID NOW™ COVID-19 assay. The Authors. Published by Elsevier B.V. 2021-08 2021-06-12 /pmc/articles/PMC8196482/ /pubmed/34174710 http://dx.doi.org/10.1016/j.jcv.2021.104896 Text en © 2021 The Authors. Published by Elsevier B.V. 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
Burnes, Laura E
Clark, Shawn T
Sheldrake, Elena
Faheem, Amna
Poon, Betty P
Christie-Holmes, Natasha
Finlay, Laura
Kandel, Christopher
Phan, Michael
Frankland, Caylin
Lau, Trevor
Gubbay, Jonathan B
Corbeil, Antoine
Katz, Kevin
Kozak, Robert A.
One swab, two tests: Validation of dual SARS-CoV-2 testing on the Abbott ID NOW™
title One swab, two tests: Validation of dual SARS-CoV-2 testing on the Abbott ID NOW™
title_full One swab, two tests: Validation of dual SARS-CoV-2 testing on the Abbott ID NOW™
title_fullStr One swab, two tests: Validation of dual SARS-CoV-2 testing on the Abbott ID NOW™
title_full_unstemmed One swab, two tests: Validation of dual SARS-CoV-2 testing on the Abbott ID NOW™
title_short One swab, two tests: Validation of dual SARS-CoV-2 testing on the Abbott ID NOW™
title_sort one swab, two tests: validation of dual sars-cov-2 testing on the abbott id now™
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8196482/
https://www.ncbi.nlm.nih.gov/pubmed/34174710
http://dx.doi.org/10.1016/j.jcv.2021.104896
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