Validation of a rapid antigen test as a screening tool for SARS-CoV-2 infection in asymptomatic populations. Sensitivity, specificity and predictive values
Keywords: 
COVID-19
RT-PCR
Rapid antigen detection
SARS-CoV-2
Screening tool
Issue Date: 
2021
Publisher Version: 
ISSN: 
1470-2118
Note: 
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/
Citation: 
Fernández-Montero, A. (Alejandro Romualdo); Argemí-Ballbé, J. (José María); Rodríguez-García, J. (José Antonio); et al. "Validation of a rapid antigen test as a screening tool for SARS-CoV-2 infection in asymptomatic populations. Sensitivity, specificity and predictive values". Clinical Medicine. 37, 2021, 100954
Abstract
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.

Files in This Item:
Thumbnail
File
pdf.pdf
Description
Size
676.74 kB
Format
Adobe PDF


Statistics and impact

Items in Dadun are protected by copyright, with all rights reserved, unless otherwise indicated.