FDA Authorizes OTC At-Home Test to Detect Influenza & COVID-19 Viruses

The U.S. Food & Drug Administration recently announced an emergency use authorization (EUA) for the Lucira COVID-19 & Flu Home Test – the “first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as flu, and SARS-CoV-2, the virus that causes COVID-19.”  The Test can be bought without a prescription and is performed “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.”  A sample swab is swirled in a viral, the viral is placed in the test unit, and results are display in 30 minutes.  In individuals with symptoms consistent with a respiratory tract infection, the Test “correctly identified 99.3% of negative and 90.1% of positive Influenza A samples, 100& of negative and 88.3% of positive COVID-19 samples, and 99.9% of negative Influenza B samples.”  The Test’s EUA requires Lucira to continue to collect samples to study its ability to detect Influenza B.  For more information, see the 2/24/2023 FDA EUA letter.