FDA approves at-home COVID-19 test


The U.S. Food and Drug Administration Tuesday approved a new test for COVID-19 that allows users to collect their own samples for evaluation, from the comfort of own homes.

The test, developed by the Laboratory Corporation of America, will be available in the next few weeks for people who have symptoms of the disease caused by the new coronavirus, SARS-CoV-2, or those at risk for serious illness after infection.

Cleared for use after the FDA re-issued an Emergency Use Authorization, it is the first COVID-19 test kit with a “home collection option” using LabCorp’s Pixel home collection kit.

“This is one more test that’s available and it has the added benefit of allowing people to test themselves from the safety of their own homes, without having to travel to a clinic or drive-through testing site,” Dr. Bobbi Pritt, a professor of laboratory medicine and pathology at the Mayo Clinic and a member of the microbiology committee at the College of American Pathologists, told .

More than 4 million Americans have already been tested for the virus, with at least 800,000 receiving positive results, according to estimates by researchers at Johns Hopkins University.

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Most public health specialists agree, however, that more people need to be tested in order to understand the true scope of the outbreak across the country, and ultimately whether or not it’s safe to relax the social distancing restrictions that have been implemented in most communities.

The Pixel kit from LabCorp is just one of several new products that can be used to help expand testing capacity, Pritt said. Like other available tests for the virus, it is a PCR molecular test that is designed to evaluate samples collected from the test-takers nose, with a specially developed swab.

“It looks a lot like a Q-tip, but it is designed to be used specifically for this test,” Pritt said. Due to concerns with sterility and other issues with conventional cotton swabs, other commercially available swabs should not be used with this test at the present time, the FDA added.

Once users have collected their nasal sample, they mail it, in an insulated package that comes with the kit, to a LabCorp lab for testing. LabCorp plans to make the kits available to consumers in most states, with a doctor’s order.

At present, most clinicians across the country are reserving testing for those who have symptoms or who may have been exposed to people with confirmed COVID-19 as well as those who would “require a change in clinical management” based on the results, Pritt said. This latter group includes those at risk for serious illness after infection, such as people with pre-existing health problems.

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