FDA Authorizes First At-Home Coronavirus Sample Collection Kit
By Hayden Brooks
April 21, 2020
The U.S. Food and Drug Administration made a big revelation on Tuesday (April 21), announcing it has authorized the first at-home coronavirus diagnostic test that allows individuals to collect and mail their samples to a laboratory.
According to reports, the FDA granted what is known as an emergency use authorization to North Carolina-based LabCorp, allowing them to make its Pixel by LabCorp COVID-19 Test home collection kits available to most states across the nation in a few weeks. The kit is only allowed with a doctor's note. With the molecular tests, users will be able to extract their sample from their nose with a Q-tip-esque cotton swab and saline, and mail it in an insulated package to a LabCorp lab for testing.
"Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options," FDA Commissioner Dr. Stephen Hahn said in a statement. "It is important to note that this is not a general authorization for at-home collection of patient samples using other collection swabs, media, or tests, or for tests fully conducted at home."
Reuters reported that the company conducts as many as 65,000 tests per day and is able to offer results within two to four days. "The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers," Hahn continued. "Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site."
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