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The U.S. Food and Drug Administration (FDA) issued emergency use authorization for two additional over-the-counter (OTC) at-home COVID-19 antigen tests. Validation data to support the emergency use authorization (EUA) of these tests were gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH.
- On Friday, February 17, 2023, the FDA authorized GenBody COVID-19 Ag Home Test (manufactured by GenBody, Inc.), an OTC COVID-19 antigen diagnostic test that shows results in 15 minutes. The test can be used for serial testing for symptomatic people within the first 5 days of symptom onset or for people who do not have symptoms.
- On Wednesday, February 22, 2023, the FDA authorized COVI-Go SARS-CoV-2 Ag Self-Test(manufactured by Mologic, Inc.), an OTC COVID-19 antigen diagnostic test that shows results in 20 minutes. The test can be used for serial testing for symptomatic people within the first 5 days of symptom onset or for people who do not have symptoms.
These tests should always be repeated if a negative result is found:
- 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.
These 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.
The EUAs issued for these tests represent 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.
Questions?
If you have questions, contact the Division of Industry and Consumer Education.
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