BURLINGTON, N.C. — LabCorp, a North Carolina-based global life sciences company, has announced that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a COVID-19 self-collection kit.
The EUA permits nasal swab specimens to be collected at home using the Pixel by LabCorp™ COVID-19 test home collection kit if recommended by a healthcare provider after completing a questionnaire.
LabCorp’s COVID-19 at-home test kit is part of the company’s continued commitment to increase the supply and availability of tests for healthcare workers and first responders who have symptoms consistent with COVID-19. Enabling individuals to self-administer sample collection will help prevent the risk of transmitting the virus to others and reduces the demand for personal protective equipment as the tests do not require a clinician to perform the test collection.
“LabCorp continues to develop new ways to help patients and healthcare providers fight the COVID-19 crisis through our leading testing capabilities and deep scientific and research expertise,”Adam Schechter, president and CEO of LabCorp said in a news release. “Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time.”
The kits will be offered through the company’s Pixel by LabCorp™ platform and initially be made available to healthcare workers and first responders who may have been exposed to the novel strand of coronavirus or may be symptomatic.
The company also intents to make COVID-19 self-collection kits available to consumers in the coming weeks. Future updates about the self-collection kits can be found on LabCorp’s COVID-19 microsite.
According to a news release, LabCorp’s COVID-19 test home collection kit has not been FDA cleared or approved, has been authorized by FDA under an EUA, and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
