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FDA Issues Emergency Use Authorization for New COVID-19 Over-the-Counter At-Home Antigen Test

On Friday, April 14, 2023, the U.S. Food and Drug Administration (FDA) issued emergency use authorization for the Azure Fastep COVID-19 Antigen Pen Home Test (manufactured by Azure Biotech, Inc.), an OTC COVID-19 antigen diagnostic test that shows results in 15 minutes.  The test can be used for serial testing for people who have symptoms within the first 6 days of symptoms or for people who do not have symptoms and undergo additional testing. Validation data to support the emergency use authorization (EUA) of this test was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH.

The test should always be repeated if a negative result is found. Specifically,

• test at least 2 times over 3 days with at least 48 hours between tests if the person has symptoms, or
• test at least 3 times over 5 days with at least 48 hours between tests if the person does not have symptoms.

This 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.

The EUA issued for this test is the latest examples of the FDA’s ongoing commitment to maintain access to long-term testing. The FDA remains committed to ensuring the public has access to accurate and reliable COVID-19 tests.

Questions?

If you have questions about this EUA announcement, contact the Division of Industry and Consumer Education.