First at-home coronavirus test approved by FDA


NASHVILLE, Tenn. (WZTV) Q —The Food and Drug Administration has approved the first at-home test for the coronavirus.

It's made by LabCorp who said, due to limited quantities, it will first be made available to healthcare workers and first responders.

The test kit includes everything needed to collect a nasal swab sample, like a specific Q-tip-style cotton swab. FDA says this swab should not be swapped out with any other cotton swabs.

"The FDA continues to work with test developers to determine whether or not Q-tip-style cotton swab can be used safely and effectively with other tests," FDA said ina news release Tuesday.

FDA said this approval now makes convenient and reliable options for people to collect samples from the comfort and safety of their own home.

“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. “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.”

The FDA approval is not a "general authorization for at-home collection of patient samples" and only applies to the LabCorp testing kit.

Right now, the kits are available in Maryland, New Jersey, New York and Rhode Island.

Learn more here.

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