The molecular single-use test, the All-In-One Test Kit, detects SARS-CoV-2 using self-collected nasal swab samples. Under the EUA, it may be used in the home for individuals aged 14 and older who are suspected of having COVID-19 and can be used in point-of-care settings for patients of all ages when samples are collected by a healthcare provider.
To take the test, the user swirls a self-collected swab in a vial that is placed into the test unit. Users can then read the test results after approximately 30 minutes directly from a light-up display to see if they are positive or negative for the coronavirus.
FDA Commissioner Stephen Hahn said the test is the first one the agency has authorized that can be fully self-administered in the home, while Center for Devices and Radiological Health Director Jeff Shuren hailed the authorization as a “significant step toward FDA’s nationwide response” to the coronavirus.
“A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic,” said Shuren. “Now, more Americans who may have COVID-19 will be able to take immediate action based on their results.”