FDA approves OTC COVID-19 tests

Nov. 26, 2021

The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to an over-the-counter (OTC) COVID-19 antigen diagnostic test and reissued an EUA for another OTC test.

The agency said the tests are authorized for people aged 14 years or older with a self-collected nasal swab sample or people aged 2 years or older when an adult collects the nasal swab sample.

First, the agency granted an emergency use authorization (EUA) for the InBios SCoV-2 Ag Detect Rapid Self-Test, which delivers results in about 20 minutes. The test can be used as a single test for people with COVID-19 symptoms within the first five days of symptom onset, or a serial test for people without symptoms, meaning the test is done two times over three days.

Second, the agency reissued the EUA to authorize use of  the Access Bio CareStart COVID-19 Antigen Home Test as a single test without a prescription for people with COVID-19 symptoms. The test was already authorized for use as a serial test without a prescription by people with or without symptoms

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