BackgroundAnalyses of diagnostic performance of SARS-CoV-2 antigen rapid diagnostic tests (AG-RDTs) based on long-term data, population subgroups and many AG-RDT types are scarce.AimWe aimed to analyse sensitivity and specificity of AG-RDTs for subgroups based on age, incidence, sample type, reason for test, symptoms, vaccination status and the AG-RDT's presence on approved lists.MethodsWe included AG-RDT results registered in Czechia's Information System for Infectious Diseases between August and November 2021. Subpopulations were analysed based on 346,000 test results for which a confirmatory PCR test was recorded ≤ 3 days after the AG-RDT; 38 AG-RDTs with more than 100 PCR-positive and 300 PCR-negative samples were individually evaluated.ResultsAverage sensitivity and specificity were 72.4% and 96.7%, respectively. We recorded lower sensitivity for age groups 0-12 (65.5%) and 13-18 years (65.3%). The sensitivity level rose with increasing SARS-CoV-2 incidence from 66.0% to 76.7%. Nasopharyngeal samples had the highest sensitivity and saliva the lowest. Sensitivity for preventive reasons was 63.6% vs 86.1% when testing for suspected infection. Sensitivity was 84.8% when one or more symptoms were reported compared with 57.1% for no symptoms. Vaccination was associated with a 4.2% higher sensitivity. Significantly higher sensitivity levels pertained to AG-RDTs on the World Health Organization Emergency Use List (WHO EUL), European Union Common List and the list of the United Kingdom's Department of Health and Social Care.ConclusionAG-RDTs from approved lists should be considered, especially in situations associated with lower viral load. Results are limited to SARS-CoV-2 delta variant.

Department of Genetics and Microbiology Faculty of Science BIOCEV Charles University Vestec Czechia

Department of Information and Knowledge Engineering Faculty of Informatics and Statistics Prague University of Economics and Business Prague Czechia

Department of Software Engineering Faculty of Information Technology Czech Technical University Prague Czechia

Department of Statistics and Probability Faculty of Informatics and Statistics Prague University of Economics and Business Prague Czechia

Institute of Health Information and Statistics of the Czech Republic Prague Czechia

National Reference Laboratory for Influenza and Respiratory Viruses National Institute of Public Health Prague Czechia

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