WASHINGTON (AP) — U.S. regulators are allowing emergency use of the first rapid coronavirus test that can be performed and developed entirely at home.
The announcement by the Food and Drug Administration late Tuesday represents an important step in U.S. efforts to expand testing options for COVID-19.
According to the FDA, the Lucira COVID-19 All-In-One Test Kit is a molecular, single-use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.
The test kit 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 (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages, but samples must be collected by a health care provider when the test is used at the POC to test patients younger than 14 years old.
The test requires a prescription, likely limiting its initial use.
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. 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. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
The FDA granted emergency authorization to the 30-minute test kit from Lucira Health, a California manufacturer.
Previously, the FDA had only allowed use of a handful of tests that allowed people to collect samples at home, which then had to be shipped to a lab.