The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular-based single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.

“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,” said FDA Commissioner Stephen M. Hahn, M.D. in a press release on Tuesday. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. 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,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “We look forward to proactively working with test developers to support the availability of more at-home test options.”  Link to the FDA press release here.

Image Credits: Flickr: Prachatai.