4 years, 1 month ago

Covid US: FDA authorizes at-home test that can give results in 10 MINUTES

The U.S. Food and Drug Administration has authorized another at-home coronavirus test for emergency use authorization. The announcement of the approval is another important, albeit small, step to increase the number of testing options available in the U.S. Quidel Corp's at-home coronavirus test received emergency use authorization from the FDA on Monday, but it does required a prescription Users collected a nasal sample and then a few drops of the solution are added. Results are available within 10 minutes, with a blue line indicating a negative COVID-19 test and a red line indicating a positive test 'The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,' said Dr Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, in a news release. 'The QuickVue At-Home COVID-19 test is another example of the FDA working with test developers to bring important diagnostics to the public.' In studies, the test demonstrated 92% accuracy, correctly identifying 84.8% of positive cases and 99.1% of negative cases 'The flexibility of our QuickVue At-Home COVID-19 Test for meeting the urgent testing needs of individuals at home will save time and enable doctors and telemedicine providers to determine appropriate treatments without exposing their staff and other patients to heightened risk of infection,' Douglas Bryant, president and CEO of Quidel Corporation, said in a statement.

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