Bibliographic Details
| Title: |
Validation of a rapid antigen test as a screening tool for SARS-CoV-2 infection in asymptomatic populations. Sensitivity, specificity and predictive values |
| Authors: |
Alejandro Fernandez-Montero, Josepmaria Argemi, José Antonio Rodríguez, Arturo H. Ariño, Laura Moreno-Galarraga |
| Source: |
EClinicalMedicine, Vol 37, Iss , Pp 100954- (2021) |
| Publisher Information: |
Elsevier, 2021. |
| Publication Year: |
2021 |
| Collection: |
LCC:Medicine (General) |
| Subject Terms: |
SARS-CoV-2, COVID-19, Rapid antigen detection, RT-PCR, Screening tool, Medicine (General), R5-920 |
| More Details: |
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. Funding: This research received no external funding. |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
2589-5370 |
| Relation: |
http://www.sciencedirect.com/science/article/pii/S2589537021002340; https://doaj.org/toc/2589-5370 |
| DOI: |
10.1016/j.eclinm.2021.100954 |
| Access URL: |
https://doaj.org/article/793811484fb042f6a293360becc9414c |
| Accession Number: |
edsdoj.793811484fb042f6a293360becc9414c |
| Database: |
Directory of Open Access Journals |
