ATLANTA, USA – The US Food and Drug Administration on October 7, granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test.
The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu). The test detects proteins from both SARS-CoV-2 (the virus that causes COVID-19) and influenza A and B (the viruses that causes flu).
This is the first over-the-counter (OTC) test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration. Other OTC flu/COVID tests are currently available under emergency use authorization.
“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. “The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions.”
The test is for use by individuals 14 years or older taking and testing their own sample, or individuals 2 years and older with a sample taken and tested by an adult. The FDA reviewed data from a study of individuals with signs and symptoms of COVID-19 and influenza, which showed that this test correctly identified 99 percent of negative and 92 percent of positive SARS-CoV-2 samples, 99.9 percent of negative Flu A and B samples, and 92.5 percent and 90.5 percent of positive Flu A and Flu B samples, respectively.
Validation data for the test was gathered through the Independent Test Assessment Program (ITAP), a National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program, in collaboration with the FDA. ITAP was launched in 2021 to accelerate test evaluation to support the FDA’s regulatory review and the availability of high-quality, accurate and reliable diagnostic tests to the public.
As with all rapid antigen tests, which generally have lower sensitivity than molecular tests, there is a risk of false negative test results. Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2, flu or another respiratory infection and should seek follow up care with their health care provider. Individuals who test positive for SARS-CoV-2 or flu should take appropriate precautions to avoid spreading the virus and should seek follow-up care with their physician or health care provider.
Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s less burdensome 510(k) pathway, whereby additional devices can obtain marketing clearance by demonstrating substantial equivalence to a predicate device.
