Fernández-Montero, AlejandroArgemi, JosepmariaRodríguez, José AntonioAriño, Arturo H.Moreno Galarraga, Laura2022-01-172022-01-1720212589-537010.1016/j.eclinm.2021.100954https://academica-e.unavarra.es/handle/2454/41790Background: Early diagnosis of SARS-CoV-2 infection is essential to reduce disease spread. Rapid antigen tests have not been sufficiently evaluated in asymptomatic patients to be used as massive population screening tools. Methods: Head-to-head evaluation of Roche SARS-CoV-2 Rapid Antigen Test and real-time reverse transcription polymerase chain reaction (RT-PCR) as SARS-CoV-2 screening tools performed in asymptomatic adults from a semi-closed community in University of Navarra (Spain) from November 2020 to January 2021. Sensitivity, specificity and predictive values were calculated using RT-PCR as reference method. Findings: Roche SARS-CoV-2 Rapid Antigen Test was performed on 2542 asymptomatic adults in a community with a SARS-CoV-2 incidence of 1·93%. It showed a sensitivity of 71·43% (CI 95%: 56·74 – 83·42) and a specificity of 99·68% (CI 95%: 99·37 - 99·86). Positive Predictive Value was 81·4 (CI 95% 66·6 – 91·61) and Negative Predictive Value was 99·44 (CI 95% 99·06 – 99·69). Test sensitivity was related to viral load, with higher sensitivity in RT-PCR cycle threshold (Ct) values under 25 (93·75%, CI 95%: 71·96 – 98·93), that dropped to 29·41% (CI 95%: 10·31- 55·96) in RT-PCR Ct values above 25. Interpretation: This study suggests that rapid antigen tests are less effective in asymptomatic population, when compared with RT-PCR. Further studies are needed to evaluate different options to improve screenings based on rapid antigen test, such as the use of clinical questionnaires to select higher risk-participants, the confirmation of negative results with RT-PCR or the use of repetitive sequential testing.6 p.application/pdfeng© The Author(s) 2021. Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 InternationalCOVID-19Rapid antigen detectionRT-PCRSARS-CoV-2Screening toolinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccess