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.
【초록키워드】 COVID-19, SARS-CoV-2, pandemic, COVID-19 pandemic, Prospective Study, Test, diagnostic, sensitivity, specificity, RT-qPCR, Rapid test, RDT, Rapid diagnostic test, nasopharyngeal swabs, nasopharyngeal, diagnostic tests, SARS-CoV-2 genome, qPCR, oropharyngeal swab, Rapid, Oropharyngeal, Swab, incidence, Ag-RDT, Switzerland, False positive, quantitative PCR, patients, Outpatient, Infectious virus, Cycle threshold value, RDTs, clinical sensitivity, Cycle threshold values, criteria, Abbott, in some, (Abbott, oropharyngeal swabs, Ag-RDTs, clinical specificity, specimen, symptomatic individuals, cut-off, positive, PanBio, RT-qPCR test, offer, NPs, Result, enrolled, required, conducted, the WHO, individuals, was obtained, 【제목키워드】 SARS-CoV-2, Diagnostic accuracy, rapid antigen test, oropharyngeal swab, PanBio,