FDA approves COVID-19 test with at-home sample collection

Coronavirus

The samples are collected from a patient's nose by a kit that contains nasal swabs and saline

Credit: Be-Art/iStock/Getty Images Plus

(WYTV) – The U.S. Food and Drug Administration approved the first diagnostic test for COVID-19 with an at-home collection option 

Specifically, the FDA reissued the emergency use authorization for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.

The samples are collected from a patient’s nose by a kit that contains nasal swabs and saline. Once that sample is collected, it’s mailed in an insulated package to a LabCorp lab for testing.

LabCorp intends to make the Pixel by LabCorp COVID-19 Test home collection kits available to customers in most states, with a doctor’s order, in the coming 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,” said FDA Commissioner Dr. Stephen M. Hahn. “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. 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 sites. 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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