FDA authorizes first at-home coronavirus diagnostic testApril 21, 2020
The US Food and Drug Administration announced Tuesday that it has authorized the first at-home coronavirus diagnostic test that allows people to collect their own samples and mail them to a lab.
The FDA granted an emergency use authorization to LabCorp, which plans to make its Pixel by LabCorp COVID-19 Test home collection kits available in most states, with a doctor’s order, in the next few weeks.
“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.
Users will be able to collect a sample from their nose using the kit, which will include Q-tip-style cotton swabs and saline, and mail it to LabCorp for testing, according to the announcement.
“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, the FDA said.
The North Carolina-based LabCorp — which launched its lab test for the illness in March — currently conducts as many as 65,000 tests a day and offers results within two to four days, Reuters reported.
“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 said in the announcement.
“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,” he added.
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