The US Food and Drug Administration has granted an Emergency Use Authorization for Lucira Health's rapid, at-home COVID-19 test, as 360Dx reports. This, it notes, is the first authorization for a rapid, at-home self-test.
"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 says in a statement. "This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission."
The Lucira COVID-19 All-In-One Test Kit is a real-time loop mediated amplification reaction-based test to detect SARS-CoV-2 in people over the age of 14 suspected of having COVID-19, 360Dx notes. It adds that the test is to return results in 30 minutes or less and cost $50 or less. In a community testing study, it had 94 percent sensitivity and 98 percent specificity, 360Dx says.
According to NPR, individuals will need a prescription for the test, which will first be available in Florida and California, before rolling out more widely in the spring.
"Expanded testing, rapid testing really could be one more tool that brings us back to a life that approaches more normalcy," Tom Bollyky from the Council on Foreign Relations tells CNN.