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

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 patient...

Full description

Saved in:
Bibliographic Details
Published in:PloS one 2021-06, Vol.16 (6), p.e0253321-e0253321
Main Authors: Ngo Nsoga, Marie Thérèse, Kronig, Ilona, Perez Rodriguez, Francisco Javier, Sattonnet-Roche, Pascale, Da Silva, Diogo, Helbling, Javan, Sacks, Jilian A, de Vos, Margaretha, Boehm, Erik, Gayet-Ageron, Angèle, Berger, Alice, Jacquerioz-Bausch, Frédérique, Chappuis, François, Kaiser, Laurent, Schibler, Manuel, Renzoni, Adriana, Eckerle, Isabella
Format: Article
Language:English
Subjects:
Antigens
Antigens, Viral - genetics
Antigens, Viral - immunology
Asymptomatic
Biology and life sciences
Coronaviruses
COVID-19
COVID-19 - diagnosis
COVID-19 - epidemiology
COVID-19 - genetics
COVID-19 - immunology
COVID-19 Nucleic Acid Testing
COVID-19 Serological Testing
Diagnostic systems
Disease transmission
Genomes
Hospitals
Humans
Infectious diseases
Laboratories
Medical diagnosis
Medicine
Medicine and health sciences
Nasopharynx - immunology
Nasopharynx - virology
Pandemics
Primary care
Prospective Studies
Research and Analysis Methods
SARS-CoV-2 - genetics
SARS-CoV-2 - immunology
Sensitivity
Severe acute respiratory syndrome
Severe acute respiratory syndrome coronavirus 2
Switzerland - epidemiology
Viral diseases
Virology
Viruses
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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. 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. 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. 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.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0253321