FDA Authorizes First Over-the-Counter At-Home Test

Monday, February 27, 2023

The U.S. Food and Drug Administration issued an emergency use authorisation (EUA) for the first over-the-counter (OTC) at-home diagnostic which can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes.

This approval of the first OTC test to detect influenza A and B and SARS-CoV-2 represents an important milestone in improving consumer access to diagnostic tests which can be performed completely at home.

The Lucira COVID-19 & Flu Home Test is a single use test for individuals with signs and symptoms consistent with a respiratory tract infection, including COVID-19. The test can be purchased without a prescription and performed completely at-home using nasal swab samples self-collected by individual’s ages 14 years or older or collected by an adult for individuals 2 years of age or older.

The test works by swirling the sample swab in a vial that is placed in the test unit. In 30 minutes or less, the test unit will display the results showing whether a person is positive or negative for Influenza A, Influenza B and COVID-19.