The Food and Drug Administration (FDA) issued an emergency use authorization on Monday for a rapid at-home COVID-19 test that delivers results without the use of an outside laboratory. The QuickVue At-Home COVID-19 Test must be obtained via prescription and can be used by individuals 14 and older, or individuals 8 and older as long as an adult collects the nasal swab sample.
The test can be prescribed by a health care provider for individuals who are within six days of symptom onset.
“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said 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.”
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The test, produced by Quidel, provides results within 10 minutes. Health care professionals can purchase the test through select authorized distributors. The company already received EUA for another rapid test in December, and earlier last month announced the opening of a manufacturing facility in Carlsbad, California, dedicated to QuickVue products.
The company said it aims to produce 600 million QuickVue SARS rapid antigen tests per year.
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“From the first days of the pandemic, Quidel has stepped up to meet the COVID-19 challenge head-on with innovative diagnostic technologies to detect coronavirus infections and expanded manufacturing to democratize access to affordable and high-quality testing,” Douglas Bryant, president and CEO, said in a press release regarding the new production plant. “The opening of our massive new QuickVue manufacturing plant is our boldest move yet and is expected to provide Quidel with the scale necessary to serve the needs of communities and institutions for frequent testing now and for years to come.”