Newly developed COVID-19 testing options were approved by the U.S. Food and Drug Administration (FDA) this week, with the granting of emergency use authorization (EUA) for an at-home test.
It marks the first at-home iteration of tests for the disease, which has infected more than 788,000 in the United States alone, according to Johns Hopkins University. This latest test was developed by the Laboratory Corporation of America, as a means of testing samples self-collected by patients at home using another of its products, the COVID-19 Test home collection kit. LabCorp was reissued an EUA to account for the new test.
“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,” Dr. Stephen Hahn, FDA Commissioner, said. “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.”
Under the new EUA, LabCorp is allowed to test samples collected from patients’ noses using its self-collection kit, which includes nasal swabs and saline. Patients self-swab then can mail their sample by insulated package to a LabCorp lab for proper testing. LabCorp intends to distribute its test nationwide, made available by a doctor’s order over the coming weeks. This is not the same as collecting samples by other collection swabs or tests, the FDA warns, and the EUA does not cover such efforts.
The FDA continues to work with the test’s developers to determine if the Q-tip-style cotton swabs involved in the kit can be used safely and effectively with other tests.