The Food and Drug Administration has approved the emergency use for an at-home, rapid-result coronavirus self-test.
The Lucira COVID-19 All-In-One Test Kit is for people 14 and older, while those 13 and younger can use it when performed by a health care provider, the FDA announced Tuesday.
“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 Stephen Hahn said in a statement. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”
Using a molecular amplification technology to look for indications of the coronavirus’s genetic material, the Lucira COVID-19 All-In-One Test Kit is single-use and available by prescription, the FDA said.
The FDA said the test can be used in such places as doctor’s offices, hospitals, urgent care centers and emergency rooms for people of all ages but the test must be collected by a health care provider.
The approved test comes amid a nationwide surge in recent weeks of coronavirus cases and hospitalizations. As of Wednesday, the U.S. has roughly 11.4 million cases and nearly 250,000 related deaths since the pandemic’s start earlier this year — both tops globally — according to a Johns Hopkins University tracker.