Self-Administered, At-Home COVID-19 Test Authorized

The U.S. Food and Drug Administration issued an emergency use authorization on November 17, 2020, 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 (real-time loop-mediated amplification reaction) 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.

“Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”