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The US Food and Drug Administration building in Silver Spring, Md.
Associated Press
WASHINGTON – US regulators on Tuesday allowed emergency use of the first rapid coronavirus test that can be performed and developed entirely at home.
The announcement by the Food and Drug Administration represents an important step in the U.S. efforts to expand testing options for COVID-19 beyond healthcare facilities and testing sites. However, the test will require a prescription, possibly limiting its initial use.
The FDA has granted emergency clearance to the 30-minute test kit from Lucira Health, a California manufacturer.
The company’s test allows users to swab to collect a nasal sample. The sample is then swirled in a vial that connects to a handheld device, which interprets the results and shows whether the person tested positive or negative for coronavirus.
To date, the agency has authorized nearly 300 tests for the coronavirus. The vast majority require a nasal swab performed by a health professional and must be processed in laboratories using high-tech testing equipment. A handful allows people to collect their own sample at home – a nasal swab or saliva – which is then shipped to a lab, which usually means waiting days for results.
Health experts have been asking for months for options to allow people to test themselves at home, reducing turnaround times and the potential spread of the virus to healthcare workers.
Lucira did not immediately respond to a request for further details.
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