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FDA Authorizes First At-Home Sample Collection for Covid-19 Test

April 21, 2020, 4:09 PM

The U.S. Food and Drug Administration has authorized the first home diagnostic kit for Covid-19 that will let people take their own nasal swabs and mail them for testing.

“With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” FDA Commissioner Stephen Hahn said in a statement Tuesday. The home collection kits will be available to consumers in most states with a doctor’s order in the coming weeks, the agency said.

At-home test collection will expand the nation’s testing capabilities and is expected to reduce the amount of protective equipment needed by health-care professionals by decreasing their direct interactions with potentially sick patients. Protective equipment has been in short supply around the U.S.

With the newly authorized kits, patients can swab their noses at home and mail the sample to LabCorp for testing. The test kits include a specific type of cotton swab to collect samples. This authorization is only for certain LabCorp tests and isn’t a general authorization for at-home collection of patient samples using other types of swabs or test kits, the agency warned.

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com