FDA approves first at-home COVID and flu combination test

The Food and Drug Administration said on Monday it has authorized the first over-the-counter flu and COVID-19 combination test for the public to have access to outside of emergency use.

The new combo test – called the Healgen Rapid Check COVID-19/Flu A&B Antigen Test — takes approximately 15 minutes to detect proteins from both COVID-19 and influenza A and B in nasal swabs, the FDA said in its announcement .

According to data from the FDA, the combination test correctly identified 99% of negative and 92% of positive COVID-19 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.

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However, the FDA said, there is a risk of false negative results as there is with all rapid antigen tests. If you get a negative and still experience symptoms of fever, cough and/or shortness of breath you may still have COVID-19, flu or another respiratory infection and should seek follow-up care with a health care provider.

Individuals who are 14 or older can take the test themselves, but younger individuals should have the help of an adult, the FDA said.

Officials said the newly available test will help expand options for individuals to receive quick information about their health as we enter the annual flu season.