FDA-Approved COVID-19 Breath Test Developed in North Texas – NBC 5 Dallas-Fort Worth

The Food and Drug Administration on Thursday issued an emergency use authorization for what it said is the first device that can detect COVID-19 in breath samples.

The InspectIR COVID-19 Breathalyzer, created by researchers at the University of North Texas, is about the size of a piece of carry-on luggage, the FDA said and can be used in doctor’s offices, hospitals and mobile testing sites. The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider.

The idea started as a breath test for THC in cannabis, but then the company behind it, Frisco-based InspectIR, pivoted to testing for coronavirus at the start of the pandemic.

The test works by simply breathing into it and it will detect chemicals associated with coronavirus.

The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.

If it’s positive you’ll be advised to get the gold standard PCR test.

“The reality is, if you were to test in the moment, that’s all that matters,” said Inspect IR president and co-founder John Redmond. “So you know, getting a PCR test, and then not getting a result back for even, you know, four hours, which is pretty fast, doesn’t help you as you step on the airplane, right?

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”

“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”

Redmond said InspectIR is following up with businesses who expressed interested in having the equipment.