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FDA Authorizes New OTC At-Home COVID-19 Tests

Per the notice below, the United States Food and Drug Administration (FDA) has authorized new over-the-counter (OTC) novel coronavirus (COVID-19) at-home tests.

FDA Authorizes More COVID-19 Over-the-Counter At-Home Antigen Tests Based on Data from the NIH Independent Test Assessment Program

The FDA authorized two more over-the-counter (OTC) at-home COVID-19 antigen tests, 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 authorizations (EUA) issued to Osang LLC for their OHC COVID-19 Antigen Self Test and Xiamen Boson Biotech Co., Ltd for their Rapid SARS-CoV-2 Antigen Test Card are examples of the FDA’s ongoing commitment to increase the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests, and to facilitate access to these tests for all Americans.  These tests:

  • Are OTC at-home COVID-19 antigen diagnostic tests that show results in 15 minutes.
  • Can be used as a serial test for people with or without symptoms, meaning the test is done two times over three days, with at least 24 hours and no more than 48 hours between tests.
  • 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.

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Questions?

If you have questions about OTC COVID-19 tests, see Coronavirus Disease 2019 Testing Basics.
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