FDA grants emergency use authorization for first COVID-19 breath test

According to an announcement by the Food and Drug Administration released on Thursday, Americans will be able to test whether they have COVID-19 with a breathalyzer.

The FDA gave emergency use authorization to a test that was developed by InspectIR Systems that takes a breath sample then analyzes for chemical compounds associated with COVID-19.

The test is the first of its kind to be authorized for use. In a study using 2,409 individuals, the test was able to correctly identify a positive COVID infection in 91.2 percent of cases, and it correctly identified negative samples 99.3 percent of the time, per the FDA’s release.

Similar results were seen in a follow-up study that was aimed at investigating the more contagious omicron variant of the coronavirus.

InspectIR noted that the test is conducted by exhaling into a tube in a similar fashion to inflating a balloon, and it should return results within just three minutes.

The FDA added that the instrument used for testing is just about the size of one piece of carry-on luggage, and that means breath tests could be performed in doctor’s offices, hospitals, and other sites.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, the director of the FDA’s Center for Devices and Radiological health.

Shuren went on to say, “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency.”

The FDA added that a positive result received from the breathalyzer test should be confirmed with a more traditional molecular test.