The US Food and Drug Administration has recently authorized a new combination at-home COVID and flu test called the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. This test screens for both Influenza A and B viruses, which cause the flu each season, as well as the virus that causes COVID-19. It is designed for individuals aged 14 and up who can take their own sample, or children as young as age 2 if an adult can take the sample for them. This authorization is significant as it is the first to give FDA approval outside of pandemic-era marketing rules, helping other companies define requirements related to labeling and performance testing for similar at-home tests.
The FDA’s Center for Devices and Radiological Health acknowledged that the new at-home test options provide individuals with respiratory symptoms the ability to receive health information from the comfort of their own homes. The FDA based its authorization on a study that looked at the test’s accuracy in identifying negative and positive samples of COVID and Influenza A and B. The Healgen test was found to correctly identify 99% of negative COVID samples and 92% of positive COVID samples, as well as 99.9% of negative Flu A and B samples and 92.5% and 90.5% of positive Flu A and B samples. Despite the high accuracy rates, there is still a risk of false negative results, as with all rapid antigen tests, meaning the test may show a negative result even if the individual is actually sick with either the flu or COVID.
The Healgen at-home tests are expected to be available over the counter by Thanksgiving this year, with a list price of approximately $13 to $16 per test. Consumers will be able to purchase the tests through retailers such as CVS and Amazon. It is important to note that if you are experiencing symptoms of any virus, regardless of test results, you should follow updated guidance on what to do when you have symptoms of a cold, the flu, or COVID. Seeking healthcare or consulting with a doctor about your symptoms is crucial, especially if you are at higher risk of severe illness from these viruses. Treatments are available to lessen the severity of illness, but the appropriate treatment depends on the specific virus and your individual health.
Overall, the authorization of the Healgen Rapid Check COVID-19/Flu A&B Antigen Test expands the options for individuals seeking at-home testing for respiratory symptoms. This development aligns with the FDA’s efforts to support the availability of at-home tests for various medical conditions. With the new test soon to be available to consumers and other similar tests likely to follow, individuals will have increased access to testing options and the convenience of conducting tests in the comfort of their own homes. As the holiday season approaches, the availability of these tests will provide peace of mind for individuals wanting to monitor their health status before gathering with family and friends.
