FDA Authorizes COVID-19 Testing Using Samples Collected by Patients at Home

The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test that allows for testing of samples self-collected by patients at home using the Pixel by LabCorp COVID-19 Test home collection kit.

The LabCorp COVID-19 Test home collection kit includes a specific Q-tip-style cotton swab and saline for patients to collect a nasal sample. Once collected, the sample can be mailed to a LabCorp lab for testing. The nasal samples will be analyzed using LabCorp’s COVID-19 RT-PCR Test for the detection of nucleic acid from SARS-CoV-2, the virus that causes COVID-19. The kit is only available if recommended by a healthcare provider based on results of a COVID-19 questionnaire. 

The Company will initially make the self-collection kits available to healthcare workers and first responders in the coming weeks. Future updates on the availability of the self-collection kit can be found here. 

In a press statement, the FDA noted that the EUA only applies to LabCorp’s self-collection kit and is not a general authorization for other kits being developed for at-home collection of patient samples using other swabs, media, or tests. 

“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,” said FDA Commissioner Stephen M. Hahn, MD. “With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”

For more information visit labcorp.com.

This article originally appeared on MPR