Name: FDA authorizes first at-home coronavirus test
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FDA authorizes first at-home coronavirus test

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The test can be used by people who are at least 14 years old when their health provider suspects they have Covid-19.The FDA said that the health care providers of patients who use the test must report the results to public health authorities. | Sarah Silbiger/Getty ImagesThe Food and Drug Administration has the first prescription at-home coronavirus test, in a long-awaited milestone.The test, developed by Lucira Health, can be used by people who are at least 14 years old when their health provider suspects they have Covid-19, the FDA said late Tuesday. The test can be used on younger people, but in that case a health care provider must collect the sample.The test involves swabbing the inside of the nose, placing the swab in a vial and swirling it before putting the vial in a “test unit.” The process gives results in 30 minutes or less.FDA medical device director Jeff Shuren said the test, which can be fully run outside a lab or health care settings, represents a significant step forward.“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,” Shuren said.The agency said that the health care providers of patients who use the test must report the results to public health authorities.Crunching the numbers: The at-home test was able to correctly identify 94 percent of positive samples and 98 percent of negative samples diagnosed using a more sensitive lab-based test in a study, according to Lucira’s instructions for use.“Excluding samples with very low levels of virus that possibly no longer reflected active infection, Lucira achieved 100% positive percent agreement,” .Background: FDA has previously granted emergency authorization for kits that allow people to take a sample in their home and send it to a lab for testing. But a test people can conduct themselves .Lucira is one of several companies that have been working to develop fully at-home tests to relieve pressure on overburdened testing laboratories and quickly identify new infections.“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Stephen Hahn said.Some public health experts, including Harvard University epidemiologist Michael Mina, argue widespread at-home testing could help bring the Covid-19 pandemic in the U.S. under control.“I believe very firmly that if we asked 100 percent of Americans — maybe we wouldn’t get there — to get tested weekly we could do it,” Mina told POLITICO. To cut down on false positives, a second at-home test that uses a different technological approach should be provided to confirm results, he added.How it will be rolled out: It’s not clear how fast Lucira will be able to ramp up manufacturing of its test. The company’s the test is “intended to cost less than $50” and is manufactured in the U.S.Lucira said the test will first be available through Sutter Health in Northern California and Cleveland Clinic Florida in Miami-Ft. Lauderdale. By spring 2021, it will be available nationally through health care providers.“While Lucira scales up manufacturing capabilities, its COVID-19 test kit will initially be available on a limited basis in point of care settings and healthcare networks that prescribe the test for patients to use at home,” the company said in a press release.What’s next: HHS testing czar Brett Giroir said the health department and Pentagon — which have made investments to boost manufacturing of other Covid-19 tests — are prepared to help Lucira “expand their scope and scale.”FDA says it is eager for more at-home tests to be on the market.“We look forward to proactively working with test developers to support the availability of more at-home test options,” Shuren said.

The test can be used by people who are at least 14 years old when their health provider suspects they have Covid-19.The FDA said that the health care providers of patients who use the test must report the results to public health authorities. | Sarah Silbiger/Getty ImagesThe Food and Drug Administration has the first prescription at-home coronavirus test, in a long-awaited milestone.The test, developed by Lucira Health, can be used by people who are at least 14 years old when their health provider suspects they have Covid-19, the FDA said late Tuesday. The test can be used on younger...

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David Lim

Politico, known originally as The Politico, is an American political journalism company based in Arlington County, Virginia, that covers politics and policy in the United States and internationally. It distributes content through its website, television, printed newspapers, radio, and podcasts. Its coverage in Washington, D.C. includes the U.S. Congress, lobbying, the media, and the presidency.

FDA authorizes first at-home coronavirus test

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