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# First Covid-19 Antigen Test Gains Authorization
- URL: https://www.fdaweb.com/first-covid-19-antigen-test-gains-authorization/
- Published: 2020-05-11T12:00:00.000Z
- Updated: 2026-09-14T16:14:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146762

FDA has issued the first emergency use authorization (EUA) for a Covid-19 antigen test. Quidel’s Sofia 2 SARS Antigen FIA diagnostic test is designed to quickly detect protein fragments found on or within the virus by testing samples collected from the nasal cavity using swabs, according to an [FDA release](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-antigen-test-help-rapid-detection-virus-causes?ref=fdaweb.com). The test is authorized for use in CLIA-certified high and moderate complexity laboratories and point-of-care testing by facilities operating under a CLIA waiver certificate. FDA says it expects more antigen tests will be authorized shortly and it is developing an EUA template for them to help manufacturers streamline submissions and help expedite its review and issuance of additional EUAs.