Multicenter Technical Validation of 30 Rapid Antigen Tests for the Detection of SARS-CoV-2 (VALIDATE).

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State: Public
Version: author
License: CC BY 4.0
Serval ID
serval:BIB_F3DCE9F873C8
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Multicenter Technical Validation of 30 Rapid Antigen Tests for the Detection of SARS-CoV-2 (VALIDATE).
Journal
Microorganisms
Author(s)
Greub G., Caruana G., Schweitzer M., Imperiali M., Muigg V., Risch M., Croxatto A., Opota O., Heller S., Albertos Torres D., Tritten M.L., Leuzinger K., Hirsch H.H., Lienhard R., Egli A.
ISSN
2076-2607 (Print)
ISSN-L
2076-2607
Publication state
Published
Issued date
15/12/2021
Peer-reviewed
Oui
Volume
9
Number
12
Pages
2589
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
During COVID19 pandemic, SARS-CoV-2 rapid antigen tests (RATs) were marketed with minimal or no performance data. We aimed at closing this gap by determining technical sensitivities and specificities of 30 RATs prior to market release. We developed a standardized technical validation protocol and assessed 30 RATs across four diagnostic laboratories. RATs were tested in parallel using the Standard Q <sup>®</sup> (SD Biosensor/Roche) assay as internal reference. We used left-over universal transport/optimum media from nasopharyngeal swabs of 200 SARS-CoV-2 PCR-negative and 100 PCR-positive tested patients. Transport media was mixed with assay buffer and applied to RATs according to manufacturer instructions. Sensitivities were determined according to viral loads. Specificity of at least 99% and sensitivity of 95%, 90%, and 80% had to be reached for 10 <sup>7</sup> , 10 <sup>6</sup> , 10 <sup>5</sup> virus copies/mL, respectively. Sensitivities ranged from 43.5% to 98.6%, 62.3% to 100%, and 66.7% to 100% at 10 <sup>5</sup> , 10 <sup>6</sup> , 10 <sup>7</sup> copies/mL, respectively. Automated assay readers such as ExDia or LumiraDx showed higher performances. Specificities ranged from 88.8% to 100%. Only 15 of 30 (50%) RATs passed our technical validation. Due to the high failure rate of 50%, mainly caused by lack of sensitivity, we recommend a thorough validation of RATs prior to market release.
Keywords
COVID-19, SARS-CoV-2, diagnostics, rapid antigen test, virus testing
Pubmed
Web of science
Open Access
Yes
Create date
04/01/2022 8:49
Last modification date
21/07/2023 6:00
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