The U.S. Food and Drug Administration (FDA) on Tuesday issued an emergency use authorization to a Covid-19 self-test that can be used at home and provide results within 30 minutes, marking the FDA’s first such approval in a move that could help expand access to testing in the country.
The single-use testing kit, made by Lucira Health, has been authorized for home use and requires self-collected nasal swab samples in individuals who are 14 or older, the FDA announced in a news release.
The test can be used on children under the age of 14 only when the sample is collected by a healthcare provider in point-of-care settings like hospitals, doctor’s offices and urgent care centers, among other places.
Currently, the test will only be available with a prescription.
The rapid test uses molecular amplification technology to detect the virus but the FDA did not share any data about its sensitivity — which determines how accurate the test is.
Dr Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said that the emergency use authorization was a significant step toward the FDA’s nationwide response to Covid-19, noting that a test that can fully be administered outside a lab or health care setting “has always been a major priority for the FDA to address the pandemic.” He added: “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.”
Despite recent positive news from Moderna and Pfizer about a potential vaccine, access to testing remains a key tool in preventing the spread of the coronavirus in the near term. The country’s top infectious disease official, Dr. Anthony Fauci, has consistently said that a cheap at-home testing system that people can use “like a pregnancy test,” will be necessary to help combat the pandemic. While the Lucira test is the first full-fledged testing kit that has been given emergency approval for home use by the FDA, the agency has previously approved tests that allowed home users to collect their own samples and mail them over to a lab for testing.
1,546,509. That’s the average number of tests the U.S. has conducted in the past 7 days according to the Covid Tracking Project while the overall positivity rate is hovering around 10%. According to CovidExitStrategy.com this means that the U.S. is only meeting 30% of its testing target at the moment.
FDA authorizes first rapid Covid-19 self-testing kit for at-home diagnosis (CNN)
FDA allows 1st rapid virus test that gives results at home (Associated Press)
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