FDA Authorizes Additional Indication for OTC COVID-19 Test

U.S. Food and Drug Administration sent this bulletin at 11/01/2021 05:47 PM EDT

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FDA - Center for Devices and Radiological Health

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FDA Authorizes Additional Indication for OraSure InteliSwab COVID-19 Over-the-Counter Antigen Test

The U.S. Food and Drug Administration (FDA) reissued the emergency use authorization (EUA) for the OraSure Technologies InteliSwab COVID-19 Rapid Test.

The InteliSwab COVID-19 Rapid Test gives results in 30 minutes and can be used:

  • Without a prescription.
  • As a single test for people with COVID-19 symptoms.
  • As a serial test for people without COVID-19 symptoms, meaning the test must be done twice over three days.
  • For people 18 years of age and older with a self-collected nasal swab sample or people 15 years of age and older when an adult collects the nasal swab sample.

The FDA reissued the EUA to authorize use of InteliSwab COVID-19 Rapid 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 COVID-19 symptoms and as a single use test with a prescription for symptomatic people who are suspected of COVID-19 by their healthcare provider.

The FDA is committed to increasing the availability of accurate and reliable at-home COVID-19 diagnostic tests, and to facilitating consumer access to these tests.

Questions?

If you have questions about OTC COVID-19 tests, contact the Division of Industry and Consumer Education.