FDA Authorizes First At-Home Sample Collection Test for COVID-19
WASHINGTON – The Food and Drug Administration Tuesday approved the first diagnostic test for the coronavirus that allows people to collect their sample at home — a development that could greatly expand testing options in states fighting to corral the outbreak.
The COVID-19 RT-PCR from LabCorp will initially only be available to health care workers and first responders under a doctor’s orders.
The sample, collected via swab, will still have to be shipped for processing back to LabCorp, which operates diagnostic labs throughout the U.S.
Before gaining access to the home test, people are screened using 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 kit available in the coming weeks. Each 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.
FDA Commissioner Stephan Hawn 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.”
“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,” he 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,” he continued.
The FDA said it will continue to work with test developers to determine whether or not Q-tip-style cotton swabs can be used safely and effectively with other tests.
