FDA Authorizes LabCorp At-Home Virus Test

U.S. health regulators on Tuesday OK'd the first coronavirus test that allows people to collect their own sample at home, a new approach that could help expand testing options in most states.

The test from Burlington-based LabCorp will initially only be available to health care workers and first responders under a doctor's orders. The sample will still have to be shipped for processing back to LabCorp, which operates diagnostic labs throughout the U.S.

Allowing people to self-swab at home would help reduce infection risks for front-line health care workers and help conserve protective gear.

For the home test, people are initially screened with an online questionnaire. If authorized by a physician, LabCorp will ship a testing kit to their home. The kit includes cotton swabs, a collection tube, an insulated pouch and box to ship the specimen back to LabCorp. To take a sample, a cotton swab is swirled in each nostril. The test results are posted online to a secure company website.

The company said it will make the test available in the coming weeks. Each kit will cost $119. The kits will not be available in Maryland, New Jersey, New York and Rhode Island. Those states have laws prohibiting testing with at-home kits.

Initially, the Food and Drug Administration required health care workers wearing masks, gloves and other protective gear to collect all samples from potential coronavirus patients, usually by sticking a long swab down the nose or throat.

More recently, the FDA has endorsed the self-swab method. LabCorp's test is the first that allows it to be done at home without supervision.

FDA Commissioner Stephen Hahn said in a statement the agency authorized the self-swab test based on data showing it is “as safe and accurate as sample collection at a doctor's office, hospital or other testing site.”

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