Healthcare workers and emergency responders are first in line to access at-home COVID-19 diagnostic test kits newly authorized by the U.S. Food and Drug Administration.
LabCorp, Burlington, N.C., is now permitted to test samples that are self-collected using the company’s at-home testing kit, the agency announced on Tuesday. Care providers are asked to complete a short eligibility assessment before ordering the test, which costs $119 including shipping and lab processing. Tests must be ordered by the person taking the test, according to the firm, which said it is prioritizing healthcare workers due to limited initial quantities.
The Pixel by LabCorp COVID-19 Test kit contains nasal swabs and saline. Self-swabs are mailed back to a LabCorp lab for testing and results are received online within one to two days, the company states on its website. The kits will be available to consumers in most states with a doctor’s order, “in the coming weeks,” it added.
The FDA had previously authorized LabCorp to test only those samples taken from patients swabbed in its laboratories.
“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, M.D., in a statement.