FDA authorizes combined at-home flu, COVID-19 tests outside EUA

On Oct. 7, 2024, the United States FDA authorized the marketing of the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, a combined at-home flu and COVID-19 rapid test. The at-home test resembles other at-home tests with which consumers might be familiar.

A person experiencing respiratory infection symptoms can self-collect a sample using a nasal swab, and the test can deliver results within 15 minutes, detecting proteins from the SARS-CoV-2 and influenza A and B viruses to determine whether a patient has contracted either illness.

Although other COVID-19/flu tests are available through emergency use authorization (EUA), this is the first combined over-the-counter (OTC) to be authorized through traditional premarket review pathways. Moreover, it is the first OTC test that detects influenza ever to be approved through traditional pathways.

As the respiratory disease season approaches, tests to detect influenza and COVID-19 are essential public health tools that can help mitigate the spread of the disease. If patients and the public can detect these infectious diseases earlier using OTC tests, they can also seek timely care and take the appropriate public health precautions to protect the individuals around them.

"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. Today's authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home," said Michelle Tarver, M.D., Ph.D., acting director of the FDA's Center for Devices and Radiological Health, in the FDA press release. "The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions."

According to the FDA press release, the test is approved for use in individuals ages two and older; however, samples should be taken and tested by an adult for those between the ages of two and 14. Those 14 and older can collect and test their own samples.

If used as instructed, the test can accurately identify 99% of negative SARS-CoV-2 and flu A and B samples. It can also accurately identify 92% of positive SARS-CoV-2 samples, 92.5% of positive flu A samples, and 90.5% of positive flu B samples.

The Independent Test Assessment Program of the National Institutes of Health Rapid Acceleration of Diagnostics Tech program validated the test.

Although the FDA has authorized this test based on the validation data, the administration acknowledges that, like all rapid antigen tests, it is less sensitive than a molecular test and carries the risk of a false negative. Individuals who test negative but continue experiencing symptoms, including fever, cough and shortness of breath, should follow up with a healthcare provider.

Veronica Salib has covered news related to the pharmaceutical and life sciences industry since 2022.