A Janesville doctor says a technology he is helping develop for medical use could allow people to learn immediately if they’re infected with COVID-19.
All it takes is a breath of air and a two-second wait.
Chris Wistrom, a doctor and codirector of prehospital and emergency medicine at Mercyhealth in Janesville, is working with a Pennsylvania environmental chemistry firm on a contactless breath analysis device he said already has shown it can screen human breath for the presence of COVID-19 within seconds.
In tests conducted earlier this fall at a drive-through testing site at Mercyhealth’s Mercy Clinic North in Janesville, Wistrom said a gas-spectrum analysis device normally used in mining and industry showed it can rapidly detect COVID-19 infection by scanning human breath for key cellular changes the virus causes in humans.
Under two waves of trials at the Janesville clinic and at Henry Ford Health System in Michigan, Wistrom said the breathalyzer technology has shown it can detect a coronavirus infection with 85% to 95% accuracy within a few seconds.
Wistrom, a former firefighter and medic, described the COVID breath analysis device as a “red-light, green-light” machine that captures a puff of breath and analyzes the moisture in it for distinct cellular changes that COVID-19 causes.
He said the device automatically self-sterilizes between tests, and it works quickly enough that one unit could process up to 1,000 COVID-19 tests per hour.
Wistrom believes that if approved for medical use, the technology could allow for real-time, non-invasive and reliable screening for COVID-19 anywhere large crowds gather.
“If we can get the technology to work right, which it’s close and getting better, you could use it at airports, stadiums, bus terminals, cruise ships, music venues, concert halls, Disney World—places where you need to screen a bunch of people very quickly,” Wistrom said. “In Wisconsin, this could be the way to get people out of (COVID-19) limbo and back to Lambeau.”
Wistrom looked into the sophisticated, gas spectrometer equipment developed by Pennsylvania laboratory firm RJ Lee Group after speaking with his brother, a research chemist Wistrom said is familiar with the technology.
Wistrom worked through approval to test RJ Lee’s devices, initially using the technology in August and September during voluntary trials to capture the breath of hundreds of people who were using a drive-through COVID-19 testing site at Mercy North.
That first wave of trials was important, Wistrom said, because the people getting tests already had been screened for possible COVID-19 symptoms. That provided the first trial with a control group that would get a typical COVID-19 test using nasal or saliva antigen tests at the same as the breathalyzer test.
The first breath test trials flagged about 116 of 982 tests as COVID positive, Wistrom said. Between that trial and another conducted later at his medical alma mater, the Henry Ford Clinic, the breath tests showed 85% to 95% accuracy.
In the quest for a vaccine and other methods to screen, treat and inoculate against COVID-19, the federal government is now fast tracking regulatory processes to test and approve new products and methods.
Late last week, the Food and Drug Administration authorized a COVID-19 vaccine developed by pharmaceutical giant Pfizer for use in the U.S.
Wistrom pointed out that it likely will take months for COVID vaccines to become available to the most of the general public.
Meanwhile, experts predict the U.S. population and the health care system will battle for months against the virus.
Wistrom said he has an investment in the development of the breath tests for medical use, but he said his employer, Mercyhealth, has no financial stake in the technology. He said it’s fairly common for health care companies to allow and encourage their doctors to test and develop new or emerging health care technology.
Wistrom said a single breath testing device such as the kind he’s tested costs about $400,000—a price he acknowledged is considerable. But he said the devices don’t create medical waste like typical virus tests, and costs to operate the machinery are next to nothing.
What’s unusual about the breath test technology and what Wistrom said might pose a challenge to getting it approved for medical use is that it’s never been used in health care testing. And unlike typical swabs or saliva tests, the breath tests don’t chemically screen human tissue or cells for COVID-19.
Instead, the technology measures the spectrum of gases present in human breath for minute changes that come when certain pathogens “invade and hijack human cells,” Wistrom said.
Wistrom said it will take more testing and development, but the technology might prove itself capable to rapidly test large crowds for myriad strains of coronavirus and even influenza.
“It’s the old adage of when the only tool you have is a hammer, all your problems look like nails. They (RJ Lee) said, ‘Well, hey, we have this hammer. How can we make this work to fix this problem?’” Wistrom said.
“I think it’s so cool because it’s very novel. And while it being novel will make it harder to get accepted and through the FDA, who cares? This is this machine could be used for any number of other things. I’m kind of geeked up about the next three or four studies to see what else we can do with it.”