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LabCorp Receives EUA for Self-Collection of COVID-19 PCR Test Samples

NEW YORK – Laboratory Corporation of America has received US Food and Drug Administration Emergency Use Authorization permitting home self-collection of samples for its COVID-19 RT-PCR test.

The FDA said separately that it was reissuing the EUA to LabCorp to allow for the self-collection of samples by patients. It is the first EUA issued by the agency for a SARS-CoV-2 test using at-home self-collection, it added.

The EUA allows patients to collect samples using LabCorp's Pixel by LabCorp COVID-19 Test home collection kit and will be available in coming weeks to consumers in most states with a doctor's order.

The kit includes nasal swabs and saline for collection and an insulated package for mailing samples to LabCorp facilities 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 Stephen Hahn said in a statement. "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."