With ITAP, FDA authorizes another home COVID-19 test

FDA Authorizes Another COVID-19 Over-the-Counter Test Based on Data from the NIH Independent Test Assessment Program   The U.S. Food and Drug Administration (FDA) authorized another over-the-counter (OTC) COVID-19 antigen test, where validation data were gathered through the FDA's collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP). The emergency use authorization (EUA) of MaximBio ClearDetect COVID-19 Antigen Home Test is another example of the FDA's commitment to increasing the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests and to facilitating access to these tests for all Americans. The MaximBio ClearDetect COVID-19 Antigen Home Test is an OTC COVID-19 antigen diagnostic test that delivers results in 15 minutes. The test can be used as: A single test for people with COVID-19 symptoms. A serial test for people without symptoms, meaning the test is done two times over three days. The test can be used for people: Age 14 years or older with a self-collected nasal swab sample. Age 2 years or older when an adult collects the nasal swab sample. Learn more here

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