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University of Iowa partnership researching rapid testing for diarrheal diseases
Emily Andersen
Oct. 20, 2023 6:00 am
University of Iowa researchers are partnering with a medical development company to create rapid tests that could quickly identify the causes of certain diarrheal diseases.
The first phase of the research was performed mostly by the company, Go Diagnostics based in Madison, Wis., and involved creating the prototypes of the rapid tests.
The University of Iowa started working on the second phase in September. This phase involves testing the rapid tests on about 400 patients experiencing diarrhea within the UI Hospitals and Clinics system, and creating data on their effectiveness and how well they compare to laboratory testing techniques.
“We’re hoping that we will be able to recruit enough patients to accurately test the device within a year. That being said, in the U.S., these types of pathogens are sporadic and rare, and it’s kind of hard to predict when and where they’ll pop up. So, we may require a year and a half in order to feel confident that we can analyze the tests with strong statistical rigor,” Dr. Kelly Baker said.
Baker started working on this project with Chang Hee Kim, the CEO of Go Diagnostics, a couple of years ago after they met at a medical conference. Baker learned that Kim’s company had been looking at ways to address cost and resource issues associated with medical diagnostic tools, and she said she was interested in working together on some research.
Baker and Kim looped in Michael Pentella, director of the University of Iowa State Hygienic Lab, and the group got a grant from National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Additional funding has come from the federal Small Business Innovation Research Contract program.
“A lot of diagnostic work happens in laboratories that have many pieces of equipment and highly trained people who’ve done microbiology for a long time. It may require multiple steps that are technical,” Baker said. “A lot of that high-end laboratory demand doesn’t translate well to a lot of the settings where disease burden may be the highest.”
The goal of the tests is to provide easier and faster diagnoses in areas where access to diagnostic labs and equipment is slim, according to Baker. This includes many low-income countries and even rural parts of the United States.
“In rural communities in Iowa if somebody has diarrhea, they may have to drive 30 or 40 miles to find a provider to see them. Then if that provider wants a diagnostic test, they would have to send that test to a hospital another 30 or 40 miles away,” Baker said. “It can take several days to run some of the diagnostic tests for diarrheal pathogens. So, it’s not timely for providers making decisions for treating patients quickly and efficiently and helping them get back onto the road of recovery.”
The tests will work to specifically identify salmonella and campylobacter bacteria in diarrhea. It does this by washing away healthy bacteria that are meant to be found in stool, and then testing what’s left for genetic markers that are specific to those two diseases, Baker said.
The test uses paper strips that display lines to show whether salmonella or campylobacter are detected, similar to how you read an at-home COVID-19 test or a pregnancy test. The test results can be available in under an hour.
“Our tests are going to be used at point of care. At the doctor’s office or at the urgent care, and then you get the results on the spot,” Kim said. “It also will help to make the choice of the antibiotic to be used, because our test can tell between bacteria that are resistant to certain antibiotics and not to others.”
Diarrheal diseases account for 1 in 9 child deaths worldwide, according to a news release from the university about the research. Antibiotics are often prescribed when testing can’t be done or can’t be done quickly to determine the exact cause of the diarrhea. This can be an issue because many strains of salmonella and campylobacter have become resistant to certain antibiotics, according to Baker.
“These two bacteria are highly prioritized in the global community — by the World Health Organization, for example — for appropriate use of antibiotics,” Baker said.
After the testing for the device is finished, researchers will complete a usability evaluation by talking with potential care providers that would use the rapid tests to determine how easily they can be used. Then researchers will have to seek FDA approval, which could take another couple of years, before the tests can be brought to market, according to Kim.
Comments: (319) 398-8328; emily.andersen@thegazette.com