News In 5 Minutes

News When You Want It

FDA grants first emergency use authorization for at-home rapid coronavirus test


U.S. regulators on Tuesday allowed emergency use of the first rapid coronavirus test that can be performed entirely at home. The announcement by the Food and Drug Administration represents an important step in U.S. efforts to expand testing options for COVID-19 beyond health care facilities and testing sites — but the test will require a prescription, likely limiting its initial use.

The FDA granted emergency authorization to the 30-minute test kit from Lucira Health, a California manufacturer.

The company’s test allows users to swab themselves to collect a nasal sample. The sample is then swirled in a vial that plugs into a portable device that interprets the results and displays whether the person tested positive or negative for the virus.

To date, the agency has authorized nearly 300 tests for coronavirus. The vast majority require a nasal swab performed by a health professional and must be processed at laboratories using high-tech testing equipment. A handful allow people to collect their own sample at home — a nasal swab or saliva — that’s then shipped to a lab, which usually means waiting days for results.

Health experts have for months called for options to allow people to test themselves at home, reducing turnaround times and the potential spread of the virus to health care workers.

Lucira did not immediately respond to a request for additional details.



Source link