On Monday the U.S. Food and Drug Administration (FDA) granted marketing authorization to Healgen for their Rapid Check COVID-19/Flu A&B Antigen Test.
The authorization allows individuals to purchase the test over the counter without a prescription.
The home test, which checks for the flu and the COVID-19 virus, uses a swab to collect a sample from the nose and gives results in about 15 minutes.
“As we enter this year’s annual flu season with respiratory illnesses such as COVID-19 on many of our minds, our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives. Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home,” said Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions.”
The test joins other similar test that are approved under emergency use authorization administered at medical facilities.
The test is for individuals 2 years and older, with persons 14 years or older able to take the test without adult supervision.