Validation of a rapid antigen test as a screening tool for SARS-CoV-2 infection in asymptomatic populations. Sensitivity, specificity and predictive values

Background: 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 r...

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Detalles Bibliográficos
Autores: Fernandez-Montero, A. (Alejandro)|||/items/0d23602b-1c19-44e7-b698-bf919bed4ea7, Argemí, J. (Josepmaria)|||/items/cc37a6af-13a2-4fe0-846c-4725cca0ae72, Rodriguez, J.A. (José Antonio)|||/items/dfeeb791-bd5d-4472-bce8-b7f54cdf8f31, Ariño-Plana, A.H. (Arturo Hugo)|||/items/f41e86c7-511c-483e-8d4b-4178ca6c96b1, Moreno, L. (Laura)|||/items/edd81804-1241-4b71-b373-d91aec44a250
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:Universidad de Navarra
Repositorio:Dadun. Depósito Académico Digital de la Universidad de Navarra
Idioma:inglés
OAI Identifier:oai:dadun.unav.edu:10171/61233
Acceso en línea:https://hdl.handle.net/10171/61233
Access Level:acceso abierto
Palabra clave:COVID-19
RT-PCR
Rapid antigen detection
SARS-CoV-2
Screening tool
Descripción
Sumario:Background: 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.

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