FDA Grants Marketing Authorization to First OTC Flu/COVID-19 Test Outside Emergency Use Declaration

The FDA announced on October 7 it had granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test is authorized for use without a prescription and is intended for individuals experiencing respiratory symptoms who prefer to test at home. Using a sample from a self-administered nasal swab, the test detects proteins from both influenza A and B and from SARS-CoV-2, providing results in approximately 15 minutes.

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The test was granted marketing authorization through a traditional premarket review pathway and so is the first OTC assessment that can detect influenza virus to be marketed outside the strictures of an emergency use declaration, according to the FDA. There are other OTC flu/SARS-CoV-2 combination tests available under emergency use authorization, the agency said.

“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,” Michelle Tarver, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health, said in an agency news release. “Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home.”

Who can use the test?

The test is indicated for use by individuals aged 14 years or older who are taking their own sample or aged 2 years and older whose sample is taken and tested by an adult. The FDA based its decision to grant authorization on data from a study of individuals with signs and symptoms of COVID-19 and influenza. The test had a sensitivity of 92% and specificity of 99% for SARS-CoV-2. It correctly identified 99.9% of negative influenza A and B samples, and 92.5% of positive influenza A and 90.5% of positive influenza B samples, according to the FDA statement.

There is a risk of false negative results with this rapid antigen test, as there is with all tests of this type, largely a result of the lower sensitivity of the rapid antigen method compared with molecular tests. In the event of a negative result in the context of ongoing symptoms such as fever, cough and/or shortness of breath, an individual should follow-up with a health care professional. For people who receive a positive result, should use standard precautions to prevent spreading either virus and also contact their health care professional.

Along with the De Novo authorization granted for this first combination test of its kind FDA is establishing special controls that specify labeling and performance testing requirements. These controls, alongside general controls, ensure the safety and effectiveness of tests of this type. This authorization also creates a new regulatory classification that will allow future tests of this kind to seek marketing clearance through the agency's 510(k) pathway by demonstrating substantial equivalence to an already authorized device.

Source: FDA authorizes marketing of first home flu and COVID-19 combination test outside of emergency use authorities. News release. US Food and Drug Administration. October 7, 2024. Accessed October 7, 2024.
https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-home-flu-and-covid-19-combination-test-outside-emergency-use