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

https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-home-flu-and-covid-19-combination-test-outside-emergency-use?utm_medium=email&utm_source=govdelivery


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