FDA approves first combo flu-COVID-19 at-home test

It's the first combination flu-COVID-19 test that you can get without a prescription and use at home, using a simple swab of your nose. (c) ConsumerAffairs

No prescription needed and you get results in about 15 minutes

The Food and Drug Administration (FDA just approved a new at-home test that can tell you if you have COVID-19 or the flu. You can buy it without a prescription at a store. 

How it works

  • You use a swab to take a sample from your nose.
  • You get results in about 15 minutes.
  • It can tell the difference between COVID-19 and influenza A and B.

Important things to know

  • It might not always be right. Like other rapid tests, there's a chance of getting a wrong result, especially if it says you're negative. If you still feel sick, talk to your doctor.
  • If you test positive, take steps to avoid spreading the virus and talk to your doctor.

This is the first at-home test like this that has been fully approved by the FDA, which means it's been carefully checked for safety and accuracy.

The FDA is also making it easier for other companies to make similar tests in the future, so we might see more options soon.

14 and over

The test is for use by individuals 14 years or older taking and testing their own sample, or individuals 2 years and older with a sample taken and tested by an adult.

The FDA reviewed data from a study of individuals with signs and symptoms of COVID-19 and influenza, which showed that this test correctly identified 99% of negative and 92% of positive SARS-CoV-2 samples, 99.9% of negative Flu A and B samples, and 92.5% and 90.5% of positive Flu A and Flu B samples, respectively. 

Can be "impactful"

“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," said Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health.

"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. 

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