FDA Authorizes New Coronavirus Test With At Home Sample Collection
BALTIMORE (WJZ) -- The United States Food and Drug Administration (FDA) announced Tuesday the authorization of a new diagnostic test for COVID-19 that has an at-home sample collection option.
The test kit, produced by LabCorp, includes a specific Q-tip type cotton swab that allows patients to collect their own sample. The FDA's ruling, which is a re-issuing of the emergency use authorization for LabCorp's test, will continue to permit testing of these self-collected samples.
"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 in a statement. "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."
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The authorization by the FDA is only for this specific test and 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."
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