FDA has authorized the first diagnostic test for covid-19 with an option for at-home sample collection. Specifically, FDA has reissued its emergency use authorization (EUA) for the Covid-19 RT-PCR test from LabCorp to permit testing of samples self-collected by patients at home, using LabCorp’s Pixel covid-19 test home collection kit.
The kit contains nasal swabs and saline. After patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp facility for testing. LabCorp intends to make the Pixel home collection kits available to consumers in most states, with a doctor’s order, in the coming weeks.
Stephen M. Hahn, MD, FDA.
“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,” says FDA Commissioner Stephen M. Hahn, MD. “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. 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. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”
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