Is it COVID or the flu? FDA gives ‘official’ permission for testing which will tell you
The US Food and Drug Administration announced this this week authorized a combination home COVID and flu test that 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 every seasonas well as the virus that causes COVID-19. The test is intended for people aged 14 and over who can take a sample themselves, or for children aged 2 and over if an adult can take the sample for them.
Other combined COVID and flu tests, like this one from Lucira/Pfizerare authorized under “Emergency Use Authorization,” but this De Novo authorization is the first to provide FDA approval outside of pandemic-era marketing rules. It also helps other companies define “labeling and performance testing requirements,” according to the FDA, so that similar at-home tests can more easily come to market and be “approved” by the agency. For consumers, this will hopefully result in more choice and access to home testing.
“Today’s approval expands the options for individuals with respiratory symptoms to receive health information from the comfort of their home,” said Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said in a press 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 the agency looked at data from a survey of people with symptoms of COVID and flu, finding that Healgen’s test correctly identified 99% of negative and 92% of positive COVID samples. It also identified 99.9% of negative influenza A and B samples, and 92.5% and 90.5% of positive influenza A and influenza B samples, the FDA said. The press release did not specify which variant 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 there is a chance that the test will show a negative result, but you could still be sick with flu or COVID. If you have symptoms of a virus, regardless of a test result or whether you have even taken a test, you should follow the following guidelines updated guidance for what to do if you have symptoms of a cold, flu or COVID. It is especially important to seek health care or call your doctor about your symptoms or illness if you are at higher risk for serious illness from COVID, flu, or RSV. There are treatments available that can reduce the severity, but which one you should get depends on the virus and your individual health.
A spokesperson for Healgen told CNET that the at-home tests are expected to be available over-the-counter by Thanksgiving this year. The list price will be about $13 to $16 per test and they will be available for purchase through CVS, Amazon and other retailers, the spokesperson said.
For more information on how to get more free COVID tests in the mail, read what you need to know about the Novavax protein-based vaccine for COVID and what you need to know about this year’s flu shots.
