FDA Authorizes first over-the-counter at-home test to detect both influenza and COVID-19 viruses

On February 24, 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 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. 

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 individuals 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 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. 

According to the FDA, in individuals with symptoms, the Lucira COVID-19 & Flu Home Test correctly identified 99.3% of negative and 90% of positive Influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative Influenza B samples. Since there are currently not enough cases of Influenza B circulating to include in a clinical study, validation confirmed that the test can identify the virus in contrived specimens, and the EUA requires Lucira to continue to collect samples to study the test’s ability to detect Influenza B in real-world settings.   

“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,” said the FDA in announcing the test. “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.”