Nov. 18, 2020 —The FDA issued an emergency use authorization to Lucira Health for its COVID-19 All-In-One Test Kit, the first COVID-19 diagnostic test for self-testing at home and that provides rapid results.
The molecular, single-use test has been authorized for home use with self-collected nasal swab samples in people age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care settings, but samples must be collected by a health care provider for people younger than 14.
The test works by swirling the self-collected sample swab in a vial, which is then placed in the test unit. In 30 minutes or less, the results can be read from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus.
The Lucira COVID-19 All-In-One Test Kit is currently authorized for prescription use only.