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Today, the U.S. Food and Drug Administration (FDA) 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 people with respiratory symptoms. The test uses a sample collected from a nasal swab to provide 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 stay on the market outside of an emergency use declaration. Other OTC flu/COVID tests are available under the criteria for emergency use authorization during a declared emergency.
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.
Questions?
If you have questions about this authorization, contact the Division of Industry and Consumer Education.
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