Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2
| Autor: | Laurent Kaiser, Isabella Eckerle, Adriana Renzoni, Manuel Schibler, Jilian A. Sacks, Diogo Da Silva, Javan Helbling, Erik Boehm, Margaretha de Vos, François Chappuis, Marie Thérèse Ngo Nsoga, Angèle Gayet-Ageron, Alice H. Berger, Francisco Javier Perez Rodriguez, Frédérique Jacquerioz-Bausch, Pascale Sattonnet-Roche, Ilona Kronig |
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| Rok vydání: | 2021 |
| Předmět: |
RNA viruses
0301 basic medicine Viral Diseases Coronaviruses Epidemiology Physiology Fevers Artificial Gene Amplification and Extension Diagnostic accuracy Polymerase Chain Reaction Medical Conditions Switzerland/epidemiology 0302 clinical medicine Nasopharynx Coughing False positive paradox Prospective Studies 030212 general & internal medicine Prospective cohort study Antigens Viral Pathology and laboratory medicine Virus Testing ddc:616 Multidisciplinary Incidence (epidemiology) Medical microbiology Viral Load Infectious Diseases COVID-19 Nucleic Acid Testing Viruses Medicine SARS CoV 2 Pathogens Viral load Switzerland Research Article medicine.medical_specialty SARS coronavirus Coronavirus disease 2019 (COVID-19) Science Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 030106 microbiology Context (language use) Research and Analysis Methods Microbiology COVID-19 Serological Testing 03 medical and health sciences Signs and Symptoms Antigen Diagnostic Medicine Virology Internal medicine parasitic diseases Viral/genetics/immunology medicine Humans Antigens Molecular Biology Techniques Pandemics Molecular Biology Infectious virus ddc:613 Medicine and health sciences Biology and life sciences SARS-CoV-2 business.industry Organisms Viral pathogens COVID-19 COVID-19/diagnosis/epidemiology/genetics/immunology Covid 19 Reverse Transcriptase-Polymerase Chain Reaction SARS-CoV-2/genetics/immunology Microbial pathogens Clinical Medicine Physiological Processes business Viral Transmission and Infection Nasopharynx/immunology/virology |
| Zdroj: | PLOS ONE, Vol. 16, No 6 (2021) P. e0253321 PLoS ONE PLoS ONE, Vol 16, Iss 6, p e0253321 (2021) |
| ISSN: | 1932-6203 |
| DOI: | 10.1371/journal.pone.0253321 |
| Popis: | Background 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. Methods 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. Results 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. Interpretation 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. |
| Databáze: | OpenAIRE |
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