Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2.

<h4>Background</h4>Antigen-detecting rapid diagnostic tests (Ag-RDTs) for the detection of SARS-CoV-2 offer new opportunities for testing in the context of the COVID-19 pandemic. Nasopharyngeal swabs (NPS) are the reference sample type, but oropharyngeal swabs (OPS) may be a more accepta...

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Main Authors: Marie Thérèse Ngo Nsoga, Ilona Kronig, Francisco Javier Perez Rodriguez, Pascale Sattonnet-Roche, Diogo Da Silva, Javan Helbling, Jilian A Sacks, Margaretha de Vos, Erik Boehm, Angèle Gayet-Ageron, Alice Berger, Frédérique Jacquerioz-Bausch, François Chappuis, Laurent Kaiser, Manuel Schibler, Adriana Renzoni, Isabella Eckerle
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2021-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0253321
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author Marie Thérèse Ngo Nsoga
Ilona Kronig
Francisco Javier Perez Rodriguez
Pascale Sattonnet-Roche
Diogo Da Silva
Javan Helbling
Jilian A Sacks
Margaretha de Vos
Erik Boehm
Angèle Gayet-Ageron
Alice Berger
Frédérique Jacquerioz-Bausch
François Chappuis
Laurent Kaiser
Manuel Schibler
Adriana Renzoni
Isabella Eckerle
author_facet Marie Thérèse Ngo Nsoga
Ilona Kronig
Francisco Javier Perez Rodriguez
Pascale Sattonnet-Roche
Diogo Da Silva
Javan Helbling
Jilian A Sacks
Margaretha de Vos
Erik Boehm
Angèle Gayet-Ageron
Alice Berger
Frédérique Jacquerioz-Bausch
François Chappuis
Laurent Kaiser
Manuel Schibler
Adriana Renzoni
Isabella Eckerle
author_sort Marie Thérèse Ngo Nsoga
collection DOAJ
description <h4>Background</h4>Antigen-detecting rapid diagnostic tests (Ag-RDTs) for the detection of SARS-CoV-2 offer new opportunities for testing in the context of the COVID-19 pandemic. Nasopharyngeal swabs (NPS) are the reference sample type, but oropharyngeal swabs (OPS) may be a more acceptable sample type in some patients.<h4>Methods</h4>We conducted a prospective study in a single screening center to assess the diagnostic performance of the Panbio™ COVID-19 Ag Rapid Test (Abbott) on OPS compared with reverse-transcription quantitative PCR (RT-qPCR) using NPS during the second pandemic wave in Switzerland.<h4>Results</h4>402 outpatients were enrolled in a COVID-19 screening center, of whom 168 (41.8%) had a positive RT-qPCR test. The oropharyngeal Ag-RDT clinical sensitivity compared to nasopharyngeal RT-qPCR was 81% (95%CI: 74.2-86.6). Two false positives were noted out of the 234 RT-qPCR negative individuals, which resulted in a clinical specificity of 99.1% (95%CI: 96.9-99.9) for the Ag-RDT. For cycle threshold values ≤ 26.7 (≥ 1E6 SARS-CoV-2 genomes copies/mL, a presumed cut-off for infectious virus), 96.3% sensitivity (95%CI: 90.7-99.0%) was obtained with the Ag-RDT using OPS.<h4>Interpretation</h4>Based on our findings, the diagnostic performance of the Panbio™ Covid-19 RDT with OPS samples, if taken by a trained person and high requirements regarding quality of the specimen, meet the criteria required by the WHO for Ag-RDTs (sensitivity ≥80% and specificity ≥97%) in a high incidence setting in symptomatic individuals.
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spelling doaj.art-3dac66c35ce74638a995fe7b08f655662022-12-21T19:54:33ZengPublic Library of Science (PLoS)PLoS ONE1932-62032021-01-01166e025332110.1371/journal.pone.0253321Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2.Marie Thérèse Ngo NsogaIlona KronigFrancisco Javier Perez RodriguezPascale Sattonnet-RocheDiogo Da SilvaJavan HelblingJilian A SacksMargaretha de VosErik BoehmAngèle Gayet-AgeronAlice BergerFrédérique Jacquerioz-BauschFrançois ChappuisLaurent KaiserManuel SchiblerAdriana RenzoniIsabella Eckerle<h4>Background</h4>Antigen-detecting rapid diagnostic tests (Ag-RDTs) for the detection of SARS-CoV-2 offer new opportunities for testing in the context of the COVID-19 pandemic. Nasopharyngeal swabs (NPS) are the reference sample type, but oropharyngeal swabs (OPS) may be a more acceptable sample type in some patients.<h4>Methods</h4>We conducted a prospective study in a single screening center to assess the diagnostic performance of the Panbio™ COVID-19 Ag Rapid Test (Abbott) on OPS compared with reverse-transcription quantitative PCR (RT-qPCR) using NPS during the second pandemic wave in Switzerland.<h4>Results</h4>402 outpatients were enrolled in a COVID-19 screening center, of whom 168 (41.8%) had a positive RT-qPCR test. The oropharyngeal Ag-RDT clinical sensitivity compared to nasopharyngeal RT-qPCR was 81% (95%CI: 74.2-86.6). Two false positives were noted out of the 234 RT-qPCR negative individuals, which resulted in a clinical specificity of 99.1% (95%CI: 96.9-99.9) for the Ag-RDT. For cycle threshold values ≤ 26.7 (≥ 1E6 SARS-CoV-2 genomes copies/mL, a presumed cut-off for infectious virus), 96.3% sensitivity (95%CI: 90.7-99.0%) was obtained with the Ag-RDT using OPS.<h4>Interpretation</h4>Based on our findings, the diagnostic performance of the Panbio™ Covid-19 RDT with OPS samples, if taken by a trained person and high requirements regarding quality of the specimen, meet the criteria required by the WHO for Ag-RDTs (sensitivity ≥80% and specificity ≥97%) in a high incidence setting in symptomatic individuals.https://doi.org/10.1371/journal.pone.0253321
spellingShingle Marie Thérèse Ngo Nsoga
Ilona Kronig
Francisco Javier Perez Rodriguez
Pascale Sattonnet-Roche
Diogo Da Silva
Javan Helbling
Jilian A Sacks
Margaretha de Vos
Erik Boehm
Angèle Gayet-Ageron
Alice Berger
Frédérique Jacquerioz-Bausch
François Chappuis
Laurent Kaiser
Manuel Schibler
Adriana Renzoni
Isabella Eckerle
Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2.
PLoS ONE
title Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2.
title_full Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2.
title_fullStr Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2.
title_full_unstemmed Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2.
title_short Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2.
title_sort diagnostic accuracy of panbio rapid antigen tests on oropharyngeal swabs for detection of sars cov 2
url https://doi.org/10.1371/journal.pone.0253321
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