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FDA Issues EUAs for OTC, At-Home COVID-19 Antigen Tests From Advin Biotech, Oceanit Foundry

NEW YORK – The US Food and Drug Administration said on Thursday it has issued Emergency Use Authorizations to two over-the-counter, at-home antigen tests for detecting the SARS-CoV-2 virus.

The Advin COVID-19 Antigen Test @Home, manufactured by San Diego-based Advin Biotech, can be used serially to test people within the first seven days of COVID-19 symptom onset or people without symptoms. It provides results in 10 minutes.

The Assure-100 Rapid COVID-19 Home Test, manufactured by Honolulu-based Oceanit Foundry, also can be used as a serial test for individuals within the first seven days of symptom onset as well as for people who do not have symptoms. Results can be achieved in 20 minutes.

Both tests are lateral flow immunoassays that qualitatively detect SARS-CoV-2 nucleocapsid protein antigens from self-collected anterior nasal swab samples.

In March, Oceanit received an EUA from the FDA for its Assure-100 Rapid COVID-19 Test, which requires anterior nasal samples to be collected by a healthcare provider.