The US Food and Drug Administration this week has authorized a combination at-home COVID and flu test consumers can use without a prescription.
The test, called the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, screens for Influenza A and B viruses, which cause flu each season, as well as the virus that causes COVID-19. The test is meant for people age 14 and up who are able to take their own sample, or children as young as age 2 if an adult can take the sample for them.
Other combined COVID and flu tests, like this one from Lucira/Pfizer, have been authorized under "emergency use authorization," but this De Novo authorization is the first to give FDA sign-off outside of pandemic-era marketing rules. It also helps other companies define the "requirements related to labeling and performance testing," per the FDA, so similar at-home tests will have an easier time making it to the market and being "cleared" by the agency. For the consumer, this hopefully results in more choice and access to at-home tests.
"Today's authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home," Dr. Michelle Tarver, acting director of the FDA's Center for Devices and Radiological Health, said in a news release. "The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions."
The FDA said that the agency looked at data from a study of people with symptoms of COVID and influenza, finding that Healgen's test correctly identified 99% of negative and 92% of positive COVID samples. It also identified 99.9% of negative Flu A and B samples, and 92.5% and 90.5% of positive Flu A and Flu B samples, the FDA said. It didn't specify in the news release which strain of COVID was circulating at the time the study was conducted.
The FDA clarified that there is a risk of false negative results, as is true for all rapid antigen tests. This means that there's a chance the test may show a negative result, but you may still be sick with either the flu or COVID. If you have symptoms of any virus, regardless of a test result or whether you've even taken a test, you should follow the updated guidance for what to do when you have symptoms of a cold, the flu or COVID. It's especially important to seek health care or call your doctor about your symptoms or illness if you're at higher risk of severe illness from COVID, flu or RSV -- there are treatments available that can lessen the severity, but which one you should receive depends on the virus and your individual health.
A spokesperson for Healgen told CNET the home tests are expected to be available over the counter by Thanksgiving this year. The list price will be around $13 to $16 per test and they'll be available for purchase through CVS, Amazon and other retailers, the spokesperson said.
For more, read about how you can get more free COVID tests through the mail, what to know about the protein-based Novavax vaccine for COVID and what to know about this year's flu shots.