The Food and Drug Administration on Tuesday gave an emergency green light to the first rapid coronavirus test that can be run from start to finish at home, paving a potential path for more widespread testing outside of health care settings.
The test, developed by the California company Lucira Health, requires a prescription from a health care provider, and people younger than 14 cannot perform the test on themselves.
But with a relatively simple nasal swab, the test can return results in about half an hour, and it is projected by the company to cost $50 or less, according to the product's website. Clinicians also can run the test on their patients, including children younger than 14, potentially delivering results during a single visit to a care center or pharmacy instead of routing a sample through a lab.
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A handful of other tests have been given emergency authorization by the FDA for at-home collection of samples, which are then shipped to a lab for processing. But Lucira's test is the first to remove the need for an intermediary.
"Today's authorization for a complete at-home test is a significant step toward the FDA's nationwide response to covid-19," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.
People who test positive for the coronavirus are advised to isolate themselves for 10 days starting from the onset of symptoms or from the day they tested positive, according to guidelines from the Centers for Disease Control and Prevention.
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Laboratory tests that look for the coronavirus' genetic material using a technique called polymerase chain reaction, or PCR, are still considered the gold standard for detecting the virus. But the new at-home test relies on similar principles, using a method called a loop-mediated isothermal amplification reaction. Like PCR, LAMP repeatedly copies the virus's genetic material until it reaches detectable levels.
According to the product's instructions, Lucira's LAMP test was able to accurately detect 94.1% of the infections found by a well-established PCR test. It also correctly identified 98% of the healthy, uninfected people. The study, which was conducted by the company, was small and included only people who had symptoms of covid-19, the disease caused by the coronavirus. The packaging for the test notes that it "has not been evaluated" in asymptomatic people.
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November 19, 2020 at 05:12PM
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At-home test given emergency approval - Northwest Arkansas Democrat-Gazette
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