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

The Food and Drug Administration has granted authorization of a COVID-19 and flu test that can be used without a prescription.  

The authorization, announced Monday, uses a nasal swab to detect the proteins from SARS-CoV-2 and Influenza A and B, or the viruses are found in COVID-19 and the flu.

The test was created by Healgen Scientific LLC, a medical equipment manufacturer based in Houston, Texas.

The announcement comes right after the U.S. Department of Health and Human Services said that households across the nation can obtain four free COVID-19 tests. In addition, flu season is expected to spark in October.  

“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,” Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said in a statement.  

“(Monday)’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home,” Tarver said.  

Here is what you need to know about the COVID-19 and flu at-home test.  

COVID-19 Tests: Free COVID-19 tests are now available. Here’s how you can get them.

Who can use the COVID-19 and flu test?  

The nasal swab test can be used independently by anyone who is 14 years or older and with adult supervision for those 2 years and older, the FDA said.  

“Getting accurate, timely diagnostic information in the safety, comfort and convenience of your own home can provide substantial benefits—including facilitating the speed for possible physician diagnosis and treatment,” Dr. Archelle Georgiou, the immediate past chair of the Board of Directors at Children’s Hospital and Clinics of Minnesota, said in a statement to .

“For the patient and the healthcare system alike, there can be substantial benefit of reducing visits to the emergency room. Reduced strain on the medical system benefits everyone,” Georgiou said.

What did the study find when using the test?  

Data from the study shows that the test identified the following results:  

• COVID-19 (SARS-CoV-2 virus): 99% of negative and 92% of positive samples.  
• Flu (Influenza A and B): 99.9% of negative; 92.5% and 90.5% of positive Flu A and Flu B samples, respectively. 

How long will it take to get my results?  

The at-home test is expected to give results within 15 minutes after the test has been administered, the FDA said.

When should I take the test?  

The FDA suggests that anyone who is experiencing respiratory symptoms should take the at-home test.  

When will the test become available?  

Healgen said that the tests will be available to the public and healthcare providers for purchase soon. The tests will be available in the U.S. by Thanksgiving.  

Where can I purchase the test?  

Healgen said anyone interested in purchasing a test can visit the following retailers:  

The tests will also be available at other retail outlets as well, the medical equipment manufacturer said.  

Healthcare providers can purchase the tests from their distributors, Healgen said.  

“This De Novo authorization represents a significant milestone for Healgen,” Bryan Fang, the president of Healgen said in a statement. “With our existing state-of-art manufacturing facility, we plan to scale up production of our respiratory tests to meet the global demand for the upcoming fall respiratory season.” 

Ahjané Forbes is a reporter on the National Trending Team at . Ahjané covers breaking news, car recalls, crime, health, lottery and public policy stories. Email her at aforbes@gannett.com. Follow her on Instagram, Threads and X (Twitter) @forbesfineest.