Validation of a rapid antigen test as a screening tool for SARS-CoV-2 infection in asymptomatic populations. Sensitivity, specificity and predictive values
| dc.contributor.author | Fernández-Montero, Alejandro | |
| dc.contributor.author | Argemi, Josepmaria | |
| dc.contributor.author | Rodríguez, José Antonio | |
| dc.contributor.author | Ariño, Arturo H. | |
| dc.contributor.author | Moreno Galarraga, Laura | |
| dc.contributor.department | Ciencias de la Salud | es_ES |
| dc.contributor.department | Osasun Zientziak | eu |
| dc.date.accessioned | 2022-01-17T12:47:54Z | |
| dc.date.available | 2022-01-17T12:47:54Z | |
| dc.date.issued | 2021 | |
| dc.description.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. 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. | en |
| dc.format.extent | 6 p. | |
| dc.format.mimetype | application/pdf | en |
| dc.identifier.doi | 10.1016/j.eclinm.2021.100954 | |
| dc.identifier.issn | 2589-5370 | |
| dc.identifier.uri | https://academica-e.unavarra.es/handle/2454/41790 | |
| dc.language.iso | eng | en |
| dc.publisher | Elsevier | |
| dc.relation.ispartof | Eclinicalmedicine, 37 (2021) | |
| dc.relation.publisherversion | http://doi.org/10.1016/j.eclinm.2021.100954 | |
| dc.rights | © The Author(s) 2021. Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International | en |
| dc.rights.accessRights | info:eu-repo/semantics/openAccess | |
| dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
| dc.subject | COVID-19 | en |
| dc.subject | Rapid antigen detection | en |
| dc.subject | RT-PCR | en |
| dc.subject | SARS-CoV-2 | en |
| dc.subject | Screening tool | en |
| dc.title | Validation of a rapid antigen test as a screening tool for SARS-CoV-2 infection in asymptomatic populations. Sensitivity, specificity and predictive values | en |
| dc.type | info:eu-repo/semantics/article | |
| dc.type.version | info:eu-repo/semantics/publishedVersion | |
| dspace.entity.type | Publication | |
| relation.isAuthorOfPublication | cd85f9b5-fe76-479b-8881-2d15bf41cf53 | |
| relation.isAuthorOfPublication.latestForDiscovery | cd85f9b5-fe76-479b-8881-2d15bf41cf53 |