The FDA announced that it issued emergency use authorization (EUA) for the first at-home, rapid COVID-19 diagnostic test.
A diagnostic designed for self-testing in the home, the Lucira COVID-19 all-in-one test kit is a molecular (real-time loop-mediated amplification reaction) single-use test designed to detect SARS-CoV-2, according to an FDA news release.
Lucira’s test is authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their healthcare provider. It’s also authorized for point-of-care settings, such as doctor’s offices, hospitals and more, for all ages, but samples must be collected by a healthcare provider when used in individuals younger than 14. It is only authorized for prescription use only.
Users swirl the self-collected sample swab in a vial before placing it in the test unit. In 30 minutes or less, the results can be read directly from the unit’s light-up display that shows whether a person is positive or negative for SARS-CoV-2.
Healthcare providers are required to report all test results they receive from individuals who use the test to their relevant public health authorities in accordance with local, state and federal requirements.
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic,” FDA Commissioner Dr. Stephen Hahn said 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.”