A breakthrough in COVID-19 testing is making it possible for patients with a doctor’s note to administer tests at home before mailing them to a lab for testing. The Food and Drug Administration (FDA) has just approved the first diagnostic test with home collection for COVID-19, according to a statement released on Tuesday.
More specifically, the FDA re-issued the emergency use authorization for the Laboratory Corporation of America (LabCorp) to allow testing samples self-collected by patients at home using LabCorp’s home collection kit, the statement 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,” said FDA Commissioner Stephen M. Hahn, M.D. He added: “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.”
The test uses a sample collected from the patient’s nose with a self-collection kit that has nasal swabs and saline. Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing.
“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 statement.
The test comes with a specific Q-tip-style cotton swab for patients to use which means you shouldn’t use other cotton swabs in place of what’s in the kit. The FDA approval only applies to the Pixel by LabCorp COVID-19 home collection kit and is not an okay for at-home collection of patient samples using other collection methods or tests.
LabCorp plans to make the Pixel by LabCorp COVID-19 Test home collection kits available to consumers in most states, with a doctor’s order, in the coming weeks. Look for updates about the kits on LabCorp’s COVID-19 microsite over the next month.