FDA approves first rapid home coronavirus test

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The US Food and Drug Administration building in Silver Spring, Md.

Associated press

WASHINGTON – U.S. regulators on Tuesday authorized emergency use of the first rapid coronavirus test that can be performed and developed entirely at home.

The Food and Drug Administration’s announcement represents an important step in U.S. efforts to expand testing options for COVID-19 beyond healthcare facilities and testing sites. However, the test will require a prescription, which will likely limit its initial use.

The FDA has granted emergency clearance for the 30-minute test kit from Lucira Health, a California manufacturer.

The company’s test allows users to rub each other to collect a nasal sample. The sample is then put into a vial that plugs into a portable device, which interprets the results and displays whether the person has tested positive or negative for the coronavirus.

To date, the agency has authorized nearly 300 tests for the coronavirus. The vast majority require a nasal swab from a healthcare professional and must be processed in laboratories using high-tech testing equipment. A handful allows people to take 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 calling for options to allow people to test themselves at home for months, reducing turnaround times and the potential spread of the virus to healthcare workers.

Lucira did not immediately respond to the request for further details.

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