On April 14, the Food and Drug Administration approved the InspectIR COVID-19 Breathalyzer, making it the first mobile diagnostic test of its kind to get the okay for commercial sale. The breathalyzer is approved for those 18 and up, and it could be used at hospitals and test sites.
“Our hospital numbers are still looking good,” Dallas County Public Health Director Dr. Phil Huang told WFAA. “We’re certainly interested in anything that can provide more rapid information, more supplemental information.”
Eventually, the device could be used at schools or in professional sports.
“Anywhere that they’re doing a nasal swab more than once a day, we’re a great fit,” Tim Wing, a co-founder of Frisco-based InspectIR Systems, told The New York Times.
The size of a carry-on, the InspectIR COVID-19 Breathalyzer uses mass spectrometry to identify compounds. Test subjects breathe into a single-use disposable straw for approximately ten seconds. The breathalyzer identifies markers associated with the novel coronavirus and produces results within minutes. It’s possible for one device to screen up to 160 samples a day.
No biological material is stored, because the chemical matter produced breathing into the straw is rapidly heated and ionized. This also cleans the device for the next user.
In a study of 2,409 individuals, the device had a 91.2 percent sensitivity in correctly identifying positive samples and a 99.3 percent specificity in correctly identifying negative samples. Individuals with a positive result should follow up with a molecular test.
Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, called the InspectIR COVID-19 Breathalyzer "another example of the rapid innovation occurring with diagnostic tests for COVID-19."
"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," added Shuren.
InspectIR Systems’ goal is to manufacture 100 of the American-made devices a week.
