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.
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.
Authors: Jacqueline Dinnes; Pawana Sharma; Sarah Berhane; Susanna S van Wyk; Nicholas Nyaaba; Julie Domen; Melissa Taylor; Jane Cunningham; Clare Davenport; Sabine Dittrich; Devy Emperador; Lotty Hooft; Mariska Mg Leeflang; Matthew Df McInnes; René Spijker; Jan Y Verbakel; Yemisi Takwoingi; Sian Taylor-Phillips; Ann Van den Bruel; Jonathan J Deeks Journal: Cochrane Database Syst Rev Date: 2022-07-22
Authors: Anastasia Tapari; Georgia G Braliou; Maria Papaefthimiou; Helen Mavriki; Panagiota I Kontou; Georgios K Nikolopoulos; Pantelis G Bagos Journal: Diagnostics (Basel) Date: 2022-06-04
Authors: Lukas E Brümmer; Stephan Katzenschlager; Sean McGrath; Stephani Schmitz; Mary Gaeddert; Christian Erdmann; Marc Bota; Maurizio Grilli; Jan Larmann; Markus A Weigand; Nira R Pollock; Aurélien Macé; Berra Erkosar; Sergio Carmona; Jilian A Sacks; Stefano Ongarello; Claudia M Denkinger Journal: PLoS Med Date: 2022-05-26 Impact factor: 11.613
Authors: Lukas E Brümmer; Stephan Katzenschlager; Mary Gaeddert; Christian Erdmann; Stephani Schmitz; Marc Bota; Maurizio Grilli; Jan Larmann; Markus A Weigand; Nira R Pollock; Aurélien Macé; Sergio Carmona; Stefano Ongarello; Jilian A Sacks; Claudia M Denkinger Journal: PLoS Med Date: 2021-08-12 Impact factor: 11.069