FDA authorizes at-home COVID-19 test

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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.