FDA expands EUA for COVID-19 at-home rapid test from OraSure

Nov. 5, 2021

The U.S. Food and Drug Administration (FDA) reissued an emergency use authorization (EUA) for the OraSure Technologies InteliSwab COVID-19 Rapid Test for use as a single test at home for people with symptoms.

The InteliSwab COVID-19 Rapid Test gives results in 30 minutes and can be used without a prescription, the FDA said.

Previously, the at-home test was authorized for over-the-counter use in people with or without symptoms when tested twice with at least 24 hours but not more than 36 hours between tests, which is called serial testing. Now, people with symptoms only need to test once; people without symptoms should still perform serial testing if they get a negative result on their first test.

The test is designed for use by 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 COVID-19 lateral flow tests use samples self-collected from the lower nostrils, using a design that incorporates a built-in swab fully integrated into the end of the test stick.

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