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Comparison of BinaxNOW and SARS-CoV-2 qRT-PCR Detection of the Omicron Variant from Matched Anterior Nares Swabs

The COVID-19 pandemic has increased use of rapid diagnostic tests (RDTs). In winter 2021 to 2022, the Omicron variant surge made it apparent that although RDTs are less sensitive than quantitative reverse transcription-PCR (qRT-PCR), the accessibility, ease of use, and rapid readouts made them a sou...

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Autores principales: Landaverde, Lena, Turcinovic, Jacquelyn, Doucette-Stamm, Lynn, Gonzales, Kevin, Platt, Judy, Connor, John H., Klapperich, Catherine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society for Microbiology 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9769721/
https://www.ncbi.nlm.nih.gov/pubmed/36255297
http://dx.doi.org/10.1128/spectrum.01307-22
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author Landaverde, Lena
Turcinovic, Jacquelyn
Doucette-Stamm, Lynn
Gonzales, Kevin
Platt, Judy
Connor, John H.
Klapperich, Catherine
author_facet Landaverde, Lena
Turcinovic, Jacquelyn
Doucette-Stamm, Lynn
Gonzales, Kevin
Platt, Judy
Connor, John H.
Klapperich, Catherine
author_sort Landaverde, Lena
collection PubMed
description The COVID-19 pandemic has increased use of rapid diagnostic tests (RDTs). In winter 2021 to 2022, the Omicron variant surge made it apparent that although RDTs are less sensitive than quantitative reverse transcription-PCR (qRT-PCR), the accessibility, ease of use, and rapid readouts made them a sought after and often sold-out item at local suppliers. Here, we sought to qualify the Abbott BinaxNOW RDT for use in our university testing program as a method to rule in positive or rule out negative individuals quickly at our priority qRT-PCR testing site. To perform this qualification study, we collected additional swabs from individuals attending this site. All swabs were tested using BinaxNOW. Initially as part of a feasibility study, test period 1 (n = 110) samples were stored cold before testing. In test period 2 (n = 209), samples were tested immediately. Combined, 102/319 samples tested severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive via qRT-PCR. All sequenced samples were Omicron (n = 92). We calculated 53.9% sensitivity, 100% specificity, a 100% positive predictive value, and an 82.2% negative predictive value for BinaxNOW (n = 319). Sensitivity would be improved (75.3%) by changing the qRT-PCR positivity threshold from a threshold cycle (C(T)) value of 40 to a C(T) value of 30. The receiver operating characteristic (ROC) curve shows that for qRT-PCR-positive C(T) values of between 24 and 40, the BinaxNOW test is of limited value diagnostically. Results suggest BinaxNOW could be used in our setting to confirm SARS-CoV-2 infection in individuals with substantial viral load, but a significant fraction of infected individuals would be missed if we used RDTs exclusively to rule out infection. IMPORTANCE Our results suggest BinaxNOW can rule in SARS-CoV-2 infection but would miss infections if RDTs were exclusively used.
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spelling pubmed-97697212022-12-22 Comparison of BinaxNOW and SARS-CoV-2 qRT-PCR Detection of the Omicron Variant from Matched Anterior Nares Swabs Landaverde, Lena Turcinovic, Jacquelyn Doucette-Stamm, Lynn Gonzales, Kevin Platt, Judy Connor, John H. Klapperich, Catherine Microbiol Spectr Research Article The COVID-19 pandemic has increased use of rapid diagnostic tests (RDTs). In winter 2021 to 2022, the Omicron variant surge made it apparent that although RDTs are less sensitive than quantitative reverse transcription-PCR (qRT-PCR), the accessibility, ease of use, and rapid readouts made them a sought after and often sold-out item at local suppliers. Here, we sought to qualify the Abbott BinaxNOW RDT for use in our university testing program as a method to rule in positive or rule out negative individuals quickly at our priority qRT-PCR testing site. To perform this qualification study, we collected additional swabs from individuals attending this site. All swabs were tested using BinaxNOW. Initially as part of a feasibility study, test period 1 (n = 110) samples were stored cold before testing. In test period 2 (n = 209), samples were tested immediately. Combined, 102/319 samples tested severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive via qRT-PCR. All sequenced samples were Omicron (n = 92). We calculated 53.9% sensitivity, 100% specificity, a 100% positive predictive value, and an 82.2% negative predictive value for BinaxNOW (n = 319). Sensitivity would be improved (75.3%) by changing the qRT-PCR positivity threshold from a threshold cycle (C(T)) value of 40 to a C(T) value of 30. The receiver operating characteristic (ROC) curve shows that for qRT-PCR-positive C(T) values of between 24 and 40, the BinaxNOW test is of limited value diagnostically. Results suggest BinaxNOW could be used in our setting to confirm SARS-CoV-2 infection in individuals with substantial viral load, but a significant fraction of infected individuals would be missed if we used RDTs exclusively to rule out infection. IMPORTANCE Our results suggest BinaxNOW can rule in SARS-CoV-2 infection but would miss infections if RDTs were exclusively used. American Society for Microbiology 2022-10-18 /pmc/articles/PMC9769721/ /pubmed/36255297 http://dx.doi.org/10.1128/spectrum.01307-22 Text en Copyright © 2022 Landaverde et al. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Research Article
Landaverde, Lena
Turcinovic, Jacquelyn
Doucette-Stamm, Lynn
Gonzales, Kevin
Platt, Judy
Connor, John H.
Klapperich, Catherine
Comparison of BinaxNOW and SARS-CoV-2 qRT-PCR Detection of the Omicron Variant from Matched Anterior Nares Swabs
title Comparison of BinaxNOW and SARS-CoV-2 qRT-PCR Detection of the Omicron Variant from Matched Anterior Nares Swabs
title_full Comparison of BinaxNOW and SARS-CoV-2 qRT-PCR Detection of the Omicron Variant from Matched Anterior Nares Swabs
title_fullStr Comparison of BinaxNOW and SARS-CoV-2 qRT-PCR Detection of the Omicron Variant from Matched Anterior Nares Swabs
title_full_unstemmed Comparison of BinaxNOW and SARS-CoV-2 qRT-PCR Detection of the Omicron Variant from Matched Anterior Nares Swabs
title_short Comparison of BinaxNOW and SARS-CoV-2 qRT-PCR Detection of the Omicron Variant from Matched Anterior Nares Swabs
title_sort comparison of binaxnow and sars-cov-2 qrt-pcr detection of the omicron variant from matched anterior nares swabs
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9769721/
https://www.ncbi.nlm.nih.gov/pubmed/36255297
http://dx.doi.org/10.1128/spectrum.01307-22
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