The FDA announced today it had granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test, which is authorized for use without a prescription, is indicated for people experiencing respiratory symptoms and want to get results at home. Test takers can utilize a nasal swab sample to provide results in approximately 15 minutes for COVID-19 and influenza. 1
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.
The test detects proteins from both SARS-CoV-2 and influenza A and B.
“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 a statement. “Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home.”
What You Need to Know
This is the first over-the-counter (OTC) test that can detect both influenza A & B and COVID-19 to be authorized through the FDA’s traditional premarket review, rather than an emergency use pathway.
The test demonstrated high accuracy in clinical trials, correctly identifying 99% of negative and 92% of positive COVID-19 samples, as well as nearly 100% of negative flu samples and over 90% of positive flu samples.
With the test’s authorization, the FDA has set special control criteria for labeling and performance.
Test Indications
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% 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.
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.
