S2, EP5 Lucira: the new at home COVID19 and flu test

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 for 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. 

The Lucira COVID-19 & Flu Home Test is a single use test and can be purchased without a prescription and performed completely at-home using nasal swab samples.  Self collection can be done by people ages 14 and older.  For people  2 years to age 13 years, an adult can help with the test.

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 doctor or healthcare team.

In patients with  symptoms, the Lucira COVID-19 & Flu Home Test correctly identified 99.3% of negative Influenza A samples and 90.1% of positive Influenza A samples.  It identified 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative Influenza B samples. The Emergency Use Authorization Act (EUA) requires Lucira to continue to collect samples to study the test’s ability to detect Influenza B in real-world settings.   

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. Additional testing may be necessary.