FDA gives emergency use authorization to at-home rapid COVID-19 test

Posted at 8:35 PM, Nov 17, 2020

The Food and Drug Administration issued an emergency use authorization on Tuesday to a rapid at-home coronavirus test, the first of its kind to receive such an approval.

The Lucira COVID-19 All-In-One Test Kit tests can be administered at home via nasal swab. Within 30 minutes, a test display will light up to give the patient’s results. The FDA says that those who receive a negative COVID-19 test but display symptoms should continue to quarantine as a negative test does not preclude someone from having the virus.

Those ages 14 and over can self-administer the test at home. Juveniles must have the test administered by a health care professional.

“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.”

Previously, the only at-home tests for the coronavirus required samples to be sent to a lab, which meant the time to get results was significantly delayed.