On December 22, 2022, the U.S. Food and Drug Administration (FDA) issued emergency use authorizations (EUAs) for two additional OTC at-home COVID-19 Tests, for ages 14 years or older with a self-collected nasal swab sample or age 2 years or older when an adult collects the nasal swab sample:
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 COVID 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.
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 COVID-19 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.
The EUAs issued for these COVID-19 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.
As of December 22, 440 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 297 molecular tests and sample collection devices, 85 antibody and other immune response tests, 57 antigen tests, and one diagnostic breath test. There are 79 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 24 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
The FDA has authorized 41 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1,186 revisions to EUA authorizations.