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First At-Home, Rapid COVID Test Approved

Though a prescription is still required
By Newser Editors and Wire Services
Posted Nov 18, 2020 12:13 AM CST

(Newser) – US regulators on Tuesday allowed emergency use of the first rapid coronavirus test that can be performed entirely at home and deliver results in 30 minutes. The announcement by the Food and Drug Administration represents an important step in US efforts to expand testing options for COVID-19 beyond health care facilities and testing sites. However, the test will require a prescription, likely limiting its initial use, the AP reports. The FDA granted emergency authorization to the single-use 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 of laboratory solution that plugs into a portable device. Results are displayed as lights labeled positive or negative.

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To date, the FDA 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 equipment. A handful of tests 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. "Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” Dr. Jeff Shuren, director of the FDA's devices center, said in a statement. The FDA has only ever approved one home test for an infectious disease—an HIV test. And even commonplace over-the-counter tests—such as home pregnancy kits—were subject to years of scrutiny before the FDA allowed their use in the 1970s.

(Read more coronavirus stories.)

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