FDA approves OTC COVID-19 test

Nov. 9, 2021

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

The EUA is for the iHealth COVID-19 Antigen Rapid Test, which delivers results in 15 minutes. The company anticipates producing 100 million tests per month, with capacity increasing to 200 million per month in early 2022, the FDA said.

The FDA said the test can be used as follows:

  • A single test for people with COVID-19 symptoms
  • A serial test for people without symptoms, meaning the test is done two times over three days

The test can be used for people 15 years or older with a self-collected nasal swab sample or for people 2 years and older when an adult collects the nasal swab sample.

Visit the FDA for more news

More on COVID