FDA Authorizes COVID-19 OTC Test in Collaboration with the NIH ITAP

SD Biosensor, Inc. COVID-19 At-Home Test delivers results in 20 minutes.

If your email program has trouble displaying this email, view as a webpage. FDA Authorizes 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 an over-the-counter (OTC) COVID-19 antigen test, the first 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 of the SD Biosensor, Inc. COVID-19 At-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 SD Biosensor, Inc COVID-19 At-Home Test will be distributed by Roche Diagnostics and is an OTC COVID-19 antigen diagnostic test that delivers results in 20 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. Read More Questions? If you have questions about OTC COVID-19 tests, see Coronavirus Disease 2019 Testing Basics.

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