FDA authorizes over-the-counter combined COVID-19 and flu home test

The Food and Drug Administration is making it easier for people to simultaneously test themselves for COVID-19 and the flu at home. 

The agency this week authorized the Healgen Scientific’s Rapid Check COVID-19/Flu A&B Antigen Test for home use without a prescription. While other at-home combination tests that can detect both COVID-19 and influenza already exist, they are currently available only under emergency-use authorization. 

The Healgen test is the first combined home COVID and flu test authorized to be marketed outside emergency use. 

“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 on Monday. “Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home.” 

Similar to other virus test kits on the market, the Healgen product entails using a nasal swab sample to detect if it shows the presence of proteins from SARS-CoV-2 (the virus that causes COVID-19) or influenza A and B (the two most common flu strains). At-home test results for both COVID-19 and flu appear in approximately 15 minutes, according to the FDA. 

The Healgen test is for self-use by individuals 14 years or older, or for young children aged 2 years and older when administered by an adult. Based on an FDA analysis, the 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. 

“As with all rapid antigen tests, which generally have lower sensitivity than molecular tests, there is a risk of false negative test results,” the FDA stated, adding that individuals with ongoing symptoms should follow up with a health care provider.