With COVID-19 cases surging, the U.S. Food and Drug Administration (FDA) made history on Nov. 17 by granting Emergency Use Authorization (EUA) to an all-in-one COVID-19 diagnostic that allows people to test themselves in their own home. Although the agency has previously authorized COVID-19 diagnostic tests for at-home sample collection, this is the first time it has given the green light to a full at-home testing kit for the virus. “A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic,” noted Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement. The At-Home Test The product making the milestone is the Lucira COVID-19 All-in-One Test Kit from Emeryville, California-based Lucira Health. The single use test is based not on PCR technology but real-time loop-mediated isothermal amplification (LAMP) that operates at ambient temperatures to detect SARS-CoV-2 RNA from self-collected swab samples. Physicians prescribe the test for patients age 14 or above that they suspect have the virus. The assay runs on a handheld battery-powered device that looks like a thermometer and which provides a result via LED readout […]