On October 7, 2024, the FDA authorized the first Flu and COVID-19 test for testing at home. The Healgen Rapid Check COVID-19/Flu A&B Antigen Test detects proteins from both SARS-CoV-2 and influenza A and B.
According to the FDA this 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.
The test was authorized for use by individuals 14 years or older who were experiencing respiratory symptoms. The test uses a nasal swab and provides results in approximately 15 minutes.
Reference
FDA News Release, October 7, 2024