On Monday, the U.S. Food and Drug Administration (FDA) granted marketing authorization to Healgen for its Rapid Check COVID-19/Flu A&B Antigen Test, providing a new tool for detecting both the flu and COVID-19 at home. With this authorization, individuals can now purchase the test over the counter without needing a prescription. told by USA Today.
The test, which uses a nasal swab to collect a sample, delivers results in approximately 15 minutes. This dual-purpose test is designed to identify both the flu and COVID-19, two of the most common respiratory illnesses that continue to affect people, particularly as the flu season approaches.
Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health, highlighted the importance of this authorization as respiratory illnesses remain a significant concern. “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,” she said.
Tarver also emphasized that the FDA remains committed to supporting the development of at-home testing options. “The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions,” she added, according to Yahoo.
The Healgen Rapid Check test joins other similar tests that have been approved under emergency use authorization, which are typically administered in medical facilities. However, this test stands out because of its accessibility, allowing users to conduct the test on their own without visiting a doctor’s office or clinic.
The test is designed for individuals aged 2 years and older. Those aged 14 and up can perform the test independently, while younger children will require adult supervision.
As respiratory illness season ramps up, the availability of this over-the-counter test provides families and individuals with a convenient way to stay informed about their health status. Whether it’s flu or COVID-19, quick and accurate results from the comfort of home may help prevent the spread of these viruses, offering a critical tool for public health during a time when respiratory infections are expected to surge.
With this authorization, the FDA hopes to ease the burden on healthcare systems and empower individuals to take proactive steps in monitoring their health during flu season and beyond.
