The first diagnostic test with a home collection option for COVID-19 was authorized by the U.S. Food and Drug Administration on Tuesday, the agency said in a news release.
The FDA said it reissued the emergency use authorization (EUA) for the Laboratory Corporation of America’s COVID-19 RT-PCR test. The EUA allows testing of samples for coronavirus, collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.
“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 Stephen M. Hahn said in the news release. “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.
"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.”
As of Tuesday morning, more than 2.5 million coronavirus cases have been diagnosed worldwide, at least 788,920 of which are in the U.S. The disease has been responsible for at least 171,810 deaths worldwide, including at least 42,458 fatalities in the United States.
The reissued EUA for LabCorp’s test permits patients to collect a sample from their noses by using a designated kit that includes nasal swabs and saline, the FDA said. Patients then mail their samples -- in an insulated package -- to a LabCorp lab for testing.
According to the FDA, LabCorp will be making its home collection kits available to consumers in most states -- with a doctor’s order -- over the next few weeks.