The U.S. Food and Drug Administration this week issued an emergency use authorization for the first COVID-19 at-home diagnostic self-test. The Lucira all-in-one test kit is a molecular (real-time loop mediated amplification reaction) single-use test intended to detect the novel coronavirus SARS-CoV-2, which causes COVID-19.
“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. The authorization, he added, “underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
For prescription use only, the test is authorized for home use with self-collected nasal swab samples for people aged 14 and older who are suspected of having COVID-19 by their healthcare providers. It also is authorized for use in point-of-care settings for all ages, but samples must be collected by a healthcare provider when the test is used at the point of care to test individuals younger than 14 years old.