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The U.S. Food and Drug Administration (FDA) authorized four additional over-the-counter (OTC) at-home COVID-19 antigen tests.
- On Monday, November 21, 2022, the FDA authorized the Fastep COVID-19 Antigen 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 as a serial test for people within the first 5 days of symptom onset or for people who do not have symptoms. The Fastep test was validated with data that was gathered through the FDA’s collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP).
- On Monday, November 21, 2022, the FDA authorized the CorDx COVID-19 Ag Test (manufactured by CorDx, Inc.), an OTC COVID-19 antigen diagnostic test that shows results in 10 minutes. The test can be used as a serial test for people within the first 7 days of symptom onset or for people who do not have symptoms.
- On Thursday, November 17, 2022, the FDA authorized the Hotgen COVID-19 Antigen Home Test (manufactured by Beijing Hotgen Biotech Co., Ltd.), an OTC COVID-19 antigen diagnostic test that shows results in 15 minutes. The test can be used as a serial test for people within the first 7 days of symptom onset or for people who do not have symptoms.
- On Thursday, November 17, 2022, the FDA authorized the NIDS COVID-19 Antigen Home Test (manufactured by ANP Technologies, Inc.), an OTC COVID-19 antigen diagnostic test that shows results in 15 minutes. The test can be used as a serial test for people within the first 5 days of symptom onset or for people who do not have symptoms. The NIDS test was validated with data that was gathered through the FDA’s collaboration with the NIH ITAP.
These tests should always be repeated if a negative result is found – at least 2 times over 3 days with at least 48 hours between tests if the person has symptoms, or 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 Emergency Use Authorizations (EUAs) issued for these tests represents 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 about this EUA announcement, contact the Division of Industry and Consumer Education.
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