The U.S. Food and Drug Administration (FDA) has authorized the 11th over-the-counter test for COVID-19. According to the agency, the FDA is committed to increasing the availability of accurate and reliable at-home COVID-19 diagnostic tests and to facilitate consumer access to these tests.
The FDA issued an emergency use authorization (EUA) for the Detect Covid-19 Test, an OTC COVID-19 diagnostic molecular test. The over-the-counter test requires the use of a compatible smartphone and a downloadable app to provide testing instructions and delivers results in about one hour.
The over-the-counter test can be used as:
- A single test for people with COVID-19 symptoms.
- A serial test for people with or without symptoms; a serial test means 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 and older when an adult collects the nasal swab sample.
Anyone with questions about OTC COVID-19 tests can contact the Division of Industry and Consumer Education.