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Background: Antigen-based point of care tests for identification of SARS-CoV-2 may markedly enhance effectiveness of population-based controlling strategies. Previous studies have demonstrated acceptable sensitivity and high specificity compared to RT-qPCR in symptomatic individuals, but test performance for asymptomatic individuals is unknown. Methods: Test performance of the Panbio COVID-19 Ag Rapid Test (Abbott) was compared to RT-qPCR in a longitudinal cohort study of asymptomatic football players and staff members of professional football clubs. Based on timing of symptoms and prior and subsequent test results, positive RT-qPCR tests were categorized as pre-symptomatic, early or late infection or persistent RNA shedding. Findings: 2425 tests were performed in 824 individuals, of which 52 (6.3%) were SARS-CoV-2 positive based on RT-qPCR. There were 2406 paired sets from asymptomatic subjects for analysis. Sixteen Panbio tests were inconclusive, for which sensitivity analyses were performed (considering results as either positive or negative or being excluded). Sensitivity of Panbio ranged from 61.76% (95% CI 49.2-73.3) to 69.12% (95% CI: 56.7-79.8) and specificity from 99.53% (95% CI: 99.2-99.8) to 100% (95% CI: 99.8-100). Sensitivity of Panbio to detect subjects with pre-symptomatic/early infection (n= 42) ranged from 81.82% (95% CI: 67.3-91.8) to 90.91% (95% CI: 78.3-97.5) with specificity always above 99%. Interpretation: In asymptomatic subjects the Panbio COVID-19 Ag Rapid Test had sensitivity of 81.82% to 90.91% and specificity above 99% for identifying pre-symptomatic and early SARS-CoV-2 infection. Funding: This study was funded by the executing institutes. The Panbio COVID-19 Ag Rapid Tests were provided by the Ministry of Health, Welfare and Sport (VWS).
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10.1101/2020.12.03.20243311
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document_parses/pdf_json/a53b9b24a94b9ae99b66b7335704e2ca965d68c3.json
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Screening for SARS-CoV-2 infection in asymptomatic individuals using the Panbio COVID-19 Antigen Rapid Test (Abbott) compared to RT-qPCR
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