FDA authorizes first rapid Covid-19 self-testing kit for at-home diagnosis (cnn.com)
(CNN)The US Food and Drug Administration has issued an emergency use authorization for the first self-test for Covid-19 that can provide rapid results at home.
The Lucira COVID-19 All-In-One Test Kit is a molecular single-use test available by prescription for self-diagnosis of the coronavirus, the agency said Tuesday.
The rapid test utilizes a molecular amplification technology to detect the virus in people with known or suspected Covid-19 and can return results in 30 minutes, the FDA said.
A molecular Covid-19 test searches for signs of the coronavirus genetic material.
"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 Hahn said in a statement.