The new test allows for patients to collect their own samples using Pixel by LabCorp COVID-19 Test home collection kits that they would then mail to a lab for testing, according to an FDA announcement Tuesday.
With a doctor’s order, the home collection kits will become available to consumers in most states in the coming weeks, the FDA said.
“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 Dr. Stephen Hahn said in the agency’s announcement.
As of Tuesday, more than 788,900 cases of coronavirus have been reported with at least 42,450 deaths, according to Johns Hopkins University.
“The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers,” Hahn said. “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. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”
The LabCorp kit includes a specific Q-tip-style cotton nasal swab for patients to use to collect their sample. The upfront pricing of the test is $119, according to the company’s website.
The FDA noted that the emergency use authorization applies only to the LabCorp COVID-19 RT-PCR Test for at-home collection, which requires a nasal swab specimen for testing using the new home collection kit.
“Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time,” Adam Schechter, president and CEO of LabCorp, said in a company release.
The coronavirus diagnostic test previously was authorized in March for emergency use by a health care provider. The FDA revised its authorization on Monday to allow for the home specimen collection method, according to an FDA letter sent to LabCorp about the approval.
The FDA said in its announcement, “It is important to note that this is not a general authorization for at-home collection of patient samples using other collection swabs, media, or tests, or for tests fully conducted at home.”