FDA Authorizes First Over-the-Counter At-Home Test to Detect Influenza, COVID-19

Today, the FDA authorized the first at home influenza and COVID-19 test. The Lucira COVID-19 & Flu 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 individuals ages 14 years and older or collected by an adult for individuals 2 years of age or older.

“Today’s authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

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 that show whether a person is positive or negative for each of the following: Influenza A, Influenza B and COVID-19. Individuals should report all results obtained to their healthcare provider for public health reporting and to receive appropriate medical care.

As with all rapid diagnostic tests, there is a risk of false positive and false negative results. Individuals who test positive for either flu or COVID-19 should take appropriate precautions to avoid spreading the virus and should seek follow-up care with their physician or healthcare provider as additional testing may be necessary.

Negative results for SARS-CoV-2 and influenza B should be confirmed, if necessary for patient management, with an authorized or cleared molecular test performed in a CLIA-certified laboratory that meets requirements to perform high or moderate complexity tests. Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have a respiratory infection and should seek follow up care with their healthcare provider.