FDA grants authorizations for two over-the-counter COVID-19 tests

Virus Antibody Antigen Epitope Social

The U.S. Food and Drug Administration (FDA) last week issued Emergency Use Authorizations (EUAs) for two additional over-the-counter (OTC) at-home COVID-19 tests.

The tests are the Advin COVID-19 Antigen Test @Home, manufactured by Advin Biotech, and the Assure-100 Rapid COVID-19 Home Test, manufactured by Oceanit Foundry.

Both tests may be used by individuals age 14 years or older with a self-collected nasal swab sample, or age two years or older when an adult collects the nasal swab sample.

The Advin Biotech COVID-19 antigen diagnostic test gives results in 10 minutes. It can be used as a serial test for people within the first seven days of symptom onset or for people who do not have symptoms, the FDA said.

The Assure-100 diagnostic test gives results in 20 minutes and can also be used as a serial test for people within the first seven days of symptom onset or for people who do not have symptoms.

As of last week, 440 tests and sample collection devices had received FDA EUAs. They include 297 molecular tests and sample collection devices, 85 antibody and other immune response tests, 57 antigen tests, and one diagnostic breath test.

Of all the tests to obtain an FDA EUA, 79 are molecular authorizations and one is an antibody authorization that can be used with home-collected samples. One EUA is for a molecular prescription at-home test, two EUAs are for antigen prescription at-home tests, 24 EUAs are for antigen over-the-counter (OTC) at-home tests, and four EUAs are for molecular OTC at-home tests.

The FDA noted that it has authorized 41 antigen tests and eight molecular tests for serial screening programs. The agency has also authorized 1,186 revisions to EUA authorizations.

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