FDA permits first home test for flu/COVID-19

The Food and Drug Administration this week permitted marketing of the first home test for influenza and COVID-19. The Healgen Rapid Check COVID-19/Flu A&B Antigen test requires individuals to use a nasal swab, with results available in about 15 minutes. It is the first home-based test permitted for marketing without an emergency use declaration. Individuals 14 years or older can take and test their own sample, or adults can take and test a sample in individuals 2 years and older. A study showed the test correctly identified 99% of negative and 92% of positive SARS-CoV-2 samples, 99.9% of negative Flu A and B samples, and 92.5% and 90.5% of positive Flu A and Flu B samples respectively. (FDA news release, 10/7/24)