Self-collection COVID-19 Test Kit Approved
North Carolina based LabCorp announced it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its at-home test.
This EUA permits nasal swab specimens to be collected at home using the Pixel by LabCorp™ COVID-19 test home collection kit.
The at-home test must be recommended by a healthcare provider after completing a COVID-19 questionnaire.
LabCorp’s COVID-19 at-home test kit enables individuals to self-administer sample collection will help to prevent the risk of transmitting the coronavirus to others and reduces the demand for personal protective equipment as the tests do not require a clinician to perform the test collection.
LabCorp’s COVID-19 test home collection kit has not been FDA cleared or approved, but has been authorized by the FDA under a EUA.
Furthermore, it has been authorized only for the detection of nucleic acid from the SARS-CoV-2 coronavirus, not for any other viruses or pathogens.
FDA Commissioner Stephen M. Hahn, M.D., said in a press release, “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 another testing site.”
“With this action today, there is now a convenient and reliable option for patients to collect samples from the comfort and safety of their home.”
The kits will initially be made available to healthcare workers and first responders who may have been exposed to COVID-19 or may be symptomatic.
LabCorp said it intends to make COVID-19 self-collection kits available to consumers in the coming weeks.
The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
“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,” said Adam Schechter, LabCorp’s CEO, in a related press 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.”
LabCorp is a leading global life sciences company that is deeply integrated with guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services.
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