FDA approves the first at-home coronavirus swab test
Now you can test if you have coronavirus from the comfort of your home. Today, the US Food and Drug Administration (FDA) approved the first coronavirus test. The test from LabCorp, will allow people to collect their own sample at home, a new approach that could help expand testing options in most states.
In announcement posted on its website, the FDA said it has re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.
The test 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.
“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.”
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 then posted online to a secure company website.