FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Flu and COVID-19 Viruses

U.S. Food and Drug Administration sent this bulletin at 02/24/2023 05:11 PM EST

If your email program has trouble displaying this email, view as a webpage.

Center for Devices and Radiological Health

FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can identify and tell the difference between 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 test for individuals with signs and symptoms consistent with a respiratory tract infection including COVID-19. As with other OTC COVID-19 tests, the Lucira test can be purchased without a prescription and performed completely at-home.

This test can be used for people:

Age 14 years or older with a self-collected nasal swab sample.

Age 2 years of age or older when an adult collects the nasal swab sample.

The Lucira test provides results in 30 minutes or less.

Read More

The EUA issued for this test represents the FDA’s ongoing commitment to increase the availability of appropriately accurate and reliable at-home diagnostic tests, including for COVID-19, and to facilitate access to these tests for all Americans. The collective impact of COVID-19, flu and RSV underscore the importance of diagnostic tests for respiratory viruses, and the FDA recognizes the benefits that at-home testing can provide. The FDA will continue to use its authorities to increase the number of appropriately accurate and easy to use at-home tests available to the public, especially tests that detect these highly contagious respiratory viruses.

Questions?

If you have questions about this EUA announcement, contact the Division of Industry and Consumer Education.

Manage Subscriptions | Unsubscribe All | Help