FDA commissioner: At-home coronavirus test as accurate as one done in doctor’s office

Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, on Wednesday said the agency’s newly authorized at-home coronavirus test is “as accurate as having it performed in the doctor’s office.”

“It’s very easy and safe to perform. Our data shows it’s as accurate as having it performed in the doctor’s office or in a clinic,” Hahn said of the test during an appearance on “CBS This Morning.” 

The new test, Hahn explained, will be an at-home collection test for a diagnostic. “That is,” Hahn said, “a test that would diagnose the presence of the COVID-19 virus.”

“It’s very easy and safe to perform. Our data shows it’s as accurate as having it performed in the doctor’s office or in a clinic.” — @SteveFDA on the first FDA authorized at-home test for the #coronavirus pic.twitter.com/QijimqcQ1R

— CBS This Morning (@CBSThisMorning) April 22, 2020

To receive the test, Hahn said those experiencing symptoms will be required to complete an online questionnaire. That survey will then be reviewed by a licensed physician, and, if “appropriate and consistent with the [Centers for Disease Control and Prevention] CDC guidelines, a package will be sent overnight with a swab and a tube.”

Hahn said the person would then be able to perform the test, put the swab in the tube of saline “and overnight it back to the lab and then get the results thereafter from LabCorp.”

LabCorp, which operates one of the world’s largest clinical laboratory providers, will be making and receiving the tests. The group did not respond to a request for comment from The Hill earlier this week regarding the number of tests that will be available and when.

Hahn said the group is going to focus on getting the tests out to “front-line health care workers and first responders” first during his interview on early Wednesday.

Hahn said the effort comes as the FDA works to expand its testing capacity in the country, where more than 820,000 coronavirus cases have been reported with more than 45,000 deaths, the latest John Hopkins University data shows. 

“We’ve had calls with the governors about it, there is unlocked capacity in the country,” he told CBS, adding: “We believe that based upon that information that we could double the number of tests that are done in a very short period of time.”