Coronavirus: FDA approves home test

November 19, 2020
Keith A. Reynolds
Keith A. Reynolds

This is the first approved COVID-19 diagnostic test that can be completed at home.

The U.S. Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for the first at-home COVID-19 coronavirus test.

According to a news release, the Lucira COVID-19 All-In-One Test Kit is a molecular single-use test that has been authorized for home performance with self-collected nasal swab samples in patients 14 and older who are suspected of infection by their physician. The test can also be used in point-of-care settings for patients of any ages, but the samples must be collected by a physician when the patient is younger than 14.

“The FDA continues to demonstrate its unprecedented speed in response to the pandemic,” FDA Commissioner Stephen M. Hahn, MD, says in the release. “While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission. Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

The release says that the test is performed by swirling the self-collected sample swab in a vial that wis then placed in the test unit. The results can be read directly from the unit’s display in 30 minutes or less.

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, says in the release. “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. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them. We look forward to proactively working with test developers to support the availability of more at-home test options.”

Physicians who prescribe the test are required to report all test results from those who use the test to the relevant public health authorities in accordance with local, state, and federal requirements, the release say.