antigen testing
FDA Issues EUAs for OTC, At-Home COVID-19 Antigen Tests From Advin Biotech, Oceanit Foundry
Both tests are lateral flow immunoassays that qualitatively detect nucleocapsid protein antigens from SARS-CoV-2 from self-collected anterior nasal swab samples.
Acon Laboratories Gains FDA EUA for Point-of-Care COVID-19 Antigen Test
The point-of-care Flowflex COVID-19 Antigen Rapid Test is one of the firm's two lateral flow assays with Emergency Use Authorizations, along with an over-the-counter test.
US Food and Drug Administration Releases Templates for Monkeypox Antigen Test Development
A summary template and a more in-depth template provide guidance on antigen test development, and the agency previously published templates for molecular tests.
FDA Grants EUAs to Lucira Health Molecular COVID/Flu Test; Azure Biotech, CorDx COVID Antigen Tests
FDA said Lucira's test is the first molecular COVID-19 test to receive FDA authorization following collaboration with NIH's Independent Test Assessment program.
Beijing Hotgen Biotech Nabs FDA EUA for COVID-19 Antigen Test
The at-home test qualitatively detects the nucleocapsid protein and is intended for use with anterior nasal swabs.