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The U.S. Food and Drug Administration (FDA) issued emergency use authorization to three additional over-the-counter (OTC) at-home COVID-19 antigen tests.
- On Tuesday, December 20, the FDA authorized the ImmuView COVID-19 Antigen Home Test (manufactured by CTK 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 7 days of symptom onset or for people who do not have symptoms.
- On Thursday, December 22, the FDA authorized the Advin COVID-19 Antigen Test @Home (manufactured by Advin Biotech 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, December 22, the FDA authorized the ASSURE-100 Rapid COVID-19 Home Test (manufactured by Oceanit Foundry LLC), an OTC COVID-19 antigen diagnostic test that shows results in 20 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.
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 Emergency Use Authorizations (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 about this EUA announcement, contact the Division of Industry and Consumer Education.
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