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FDA approves university-developed COVID-19 breathalyzer test

FDA approves university-developed COVID-19 breathalyzer test

FDA approves university-developed COVID-19 breathalyzer test
May 05
13:30 2022

The Food and Drug Administration recently approved a COVID-19 breathalyzer test for emergency use, a technology that was developed by a team of researchers at the university’s chemistry department. 

The InspectIR COVID-19 Breathalyzer is the first FDA-approved test that detects chemical compounds in breath samples associated with the coronavirus. The test can be performed in doctors’ offices, hospitals and mobile testing sites using a piece of equipment about the size of a piece of carry-on luggage, with results ready in less than three minutes. The sensor has a 91.2 percent accuracy rate in detecting positive tests and 99.3 percent accuracy in detecting negative tests, according to an FDA press release

UNT Professor Guido Verbeck poses in the Hickory Hall lab on May 2, 2022. Maria Crane

Guido Verbeck, a professor in the Department of Chemistry and the director of the Laboratory of Imaging Mass Spectrometry, guided the researchers on the project. Verbeck said the product was able to get to the point it is now due to the collaboration with InspectIR systems, a research development and device company focused on portable COVID-19 diagnostic screening applications.

“It’s always good that we have a great partnership with an industry that is really interested in pursuing it, and InspectIR was,” Verbeck said. “All of us have a lot of good research, but you’ve got to find a good industrial partner that is in it to win it and go through the process necessary to get FDA approval.”

The project initially started as an effort to detect THC and opioids, but as development was reaching the final stages, the coronavirus pandemic hit, Verbeck said. The team then wondered if the same technology could be used to detect COVID-19 in the breath. 

“There’s a lot of literature that showed some certain markers for other diseases, like the flu and rhinoviruses and different things like that, so we applied that to COVID,” Verbeck said. 

Department of Chemistry Chair LeGrande Slaughter told the North Texas Daily the technology is “sure to be a game changer.”

“Instead of submitting to an uncomfortable nasal swab and waiting hours or days, people will simply have to breathe into a tube, and they will find out in minutes if they have a likely infection,” Slaughter said.

John Redmond, president and co-founder of InspectIR systems, said it could take between 10 and 12 weeks for the device to hit the market, as positive controls need to be set in place so that the instrument can be calibrated and ready for everyday use. 

“We just got our authorization on the 14th of April, so as you can imagine, the regulatory process was daunting,” Redmond said. “Now turning this into a real business regarding distribution and manufacturing, there [are] positive controls and some fight, so there [are] some things that we need to do to make the test ready for public consumption.”

The company will aim to produce about 100 devices a week, which can each be used to evaluate approximately 160 samples per day, according to the FDA. Redmond said COVID-19 testing rates in Texas have dropped dramatically and he hopes the breathalyzer test could provide easier accessibility.

An example of the portable system sits in Hickory Hall on May 2, 2022. Maria Crane

What we talked about with the FDA almost two years ago was having a better surveillance tool and a screening tool and that’s what we’ve done,” Redmond said. “We want to do a better job of getting people that need the test to the test.”

Biology junior David Mowles said he was excited when he heard about the breathalyzer test and he sees several ways in which it will be beneficial to the COVID-19 testing landscape. 

“I just see it as being a lot more practical since you can get the results so quickly and with such high accuracy,” Mowles said. “I feel like it could also be better because some people have obstructed nose pathways, so a breathalyzer would be easy access as there are no obstacles.”

To receive FDA authorization, results from over 2,400 samples were taken to test for accuracy, a process that Verbeck said is often very challenging. 

“It’s very exciting and it’s a little bit crazy because a lot of breathwork has been done for a long time,” Verbeck said. “This was the very first FDA-approved device ever for any breath analysis, not just for COVID.”

Feated Image: Hunter Bernard demonstrates the commercially available version of the COVID-19 test by blowing into a tube on May 3, 2022. Photo by Maria Crane

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Jillian Nachtigal

Jillian Nachtigal

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