FDA authorizes COVID-19 OTC antigen test

Nov. 23, 2021

The U.S. Food and Drug Administration (FDA) has authorized another over-the-counter (OTC) COVID-19 antigen test. The agency has issued an emergency use authorization (EUA) for the InBios SCoV-2 Ag Detect Rapid Self-Test, an OTC COVID-19 antigen diagnostic test that 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.
  • A serial test for people without symptoms, meaning the test is done two times over three days.
  • The test 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.

FDA press release

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