The COVID-19 breathalyzer test, developed by Ohio State researchers, has yet to receive approval from the U.S. Food and Drug Administration. Credit: Courtesy of Fateh Mikaeili
Ohio State is holding its breath for when its home-developed COVID-19 breathalyzer test will be approved to screen students by the U.S. Food and Drug Administration.
Perena Gouma, the lead inventor of the breathalyzer, said the breathalyzer test has been awaiting FDA Emergency Use Authorization since September, but the development of the COVID-19 vaccine and transfer of power to a new presidential administration has put the approval on hold. Gouma, the Orton Chair of the Department of Materials Science and Engineering, said there are hundreds of applications for molecular COVID-19 testing ahead of the breathalyzer, but she expects it to be approved by February.
According to the FDA website, an Emergency Use Authorization is a system to facilitate the availability and use of medical countermeasures during public health emergencies. An EUA enables the FDA to allow the use of unapproved medical products or the use of these products to treat and prevent fatal diseases that lack any alternative.
Gouma said the breathalyzer is able to detect COVID-19 in 15 seconds, looking at the virus’ biomarkers in a person’s breath, which are present when someone has an active, contagious infection. The test has a 95 to 96 percent accuracy, she said.
Gouma said because the test does not look at genetic material that is specific to COVID-19 like the saliva and nasal swab tests, it’s harder for people to accept the test’s credibility.
The breathalyzer’s development was financed through grants from the National Science Foundation, Gouma said. The project was not one of the 24 to receive COVID-19 seed funding in the spring from Ohio State.
“The [Ohio State] research foundation hasn’t really contributed yet to our work,” Gouma said. “What we suggest is, ‘Why don’t we put these prototypes all over Ohio State for surveillance?’ We know now that it’s better than the saliva test.”
Gouma said the breathalyzer test is less expensive than the nasal swab and saliva tests and is a portable device that people will be able to purchase individually on Amazon and other companies once it is approved. Ohio State can then choose to use the test to screen its students.
Ohio State has chosen to use testing methods, such as the saliva and nasal swab, that received the Emergency Use Authorization from the FDA in the fall and continues to evaluate new emerging technologies to control COVID-19, Janet Weisenberger, senior associate vice president of the Office of Research, said in an email. Over the course of the fall semester, the university transitioned to the on-campus Applied Microbiology Services Laboratory to reduce testing expenses.
“We do though remain very interested in Dr. Gouma’s work and seeing the results of her testing for the breathalyzer technology, which appears to show great promise as a testing tool for respiratory infections,” Weisenberger said.
