FDA authorizes first at-home, self-test for COVID-19

National Coronavirus Coverage

FILE – This Thursday, Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency’s campus in Silver Spring, Md. FDA officials on Tuesday, Nov. 17, 2020, allowed emergency use of the first rapid coronavirus test that can be performed and developed entirely at home. (AP Photo/Jacquelyn Martin, File)

WASHINGTON (WJHL) — Federal officials have approved a COVID-19 test that can be fully administered at home and provide rapid results.

The Food and Drug Administration (FDA) on Tuesday issued an emergency use authorization for the Lucira COVID-19 All-In-One Test Kit.

The kit is currently authorized for prescription use only by individuals suspected of having COVID-19. It works by swirling a self-collected nasal swab in a vial and placing it in the test unit. The FDA says the results can be read in 30 minutes or less using the unit’s light-up display.

“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,” FDA Commissioner Dr. Stephen M. Hahn in a release. “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.”

The test has also been authorized for use by doctor’s offices, hospitals, urgent care clinics, and other point-of-care settings.

The FDA says health care providers who prescribe the test are required to report the test results they receive to public health authorities.

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