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The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Laboratory Corporation of America’s (LabCorp) Covid-19 RT-PCR test that enables at-home sample collection.
It is the first diagnostic test authorised by the agency with a home collection option.
The authorisation enables collection of nasal swab specimens at home using the Pixel by LabCorp Covid-19 test home collection kit.
FDA commissioner Stephen Hahn said: “The FDA’s around-the-clock work since this outbreak began has resulted in the authorisation 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 another testing site. With this action, there is now a convenient and reliable option for a patient sample collection from the comfort and safety of their home.”
LabCorp’s self-collection kit includes nasal swabs and saline. The patients are required to mail their sample in an insulated package to a company lab for testing after collecting their nasal sample through self-swab.
The company noted that allowing individuals to self-administer sample collection will help prevent the risk of transmitting the virus to others.
LabCorp CEO and president Adam Schechter said: “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.
“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 company’s Pixel by LabCorp platform will initially offer the kits to healthcare workers and first responders who may have been exposed to Covid-19 or may be symptomatic. The collection kits will be made available to consumers with a doctor’s order in the coming weeks.