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FEBRUARY 27, 2023

FDA Authorizes First OTC At-Home RDT for Influenza A, B and SARS-CoV-2


Originally published by our sister publication Infectious Disease Special Edition

Updated at 5:44 p.m. Feb. 27.

The FDA issued an emergency use authorization (EUA) for the COVID-19 & Flu Home Test (Lucira), the first over-the-counter diagnostic test that can be used at home to differentiate and detect influenza A, B and SARS-CoV-2.

single-use test is intended for the self-collection of nasal samples from people aged 14 years and older with signs and symptoms consistent with respiratory tract