Lyme disease is difficult to detect. But a new device could make it almost as easy as taking your temperature

Two prominent researchers with ties to the Canadian Lyme Disease Foundation are studying a new tool that could make diagnosing the illness almost as easy as taking your temperature.

Dr. Vett Lloyd is a member of CanLyme’s board of directors. Dr. Anna Ignaszak sits on the foundation’s advisory board.

The researchers will test a method that uses a small electrochemical biosensor — like the devices diabetics use to detect their blood sugar levels — to identify two bacteria identified in people’s urine. Those bacteria are transmitted to people through the bite of infected ticks.

“It is a tiny device similar to a digital thermometer,” said Ignaszak, a professor of chemistry at the University of New Brunswick.

Ignaszak, who has devoted much of her research to finding real-world applications for various types of electrochemical sensors, says the device would be dipped in a typical urine sample you might give in a hospital or a doctor’s office, or even in your own home.

“The reading of the result will be seen on a digital display, or it can be coupled with everyday electronics,” she wrote, adding that it would work with a “laptop, tablet, or cell phone through WiFi, Bluetooth or a conventional USB port.”

Patients could use sensor at home or outdoors

She says even more importantly, the device could be used at home or during outdoor activities, like camping or hiking, as well as in hospitals and doctors’ offices.

Lyme is notoriously difficult to diagnose. Doctors and patients often mistake its symptoms for those of other illnesses and by the time they finally do identify it, the disease can be extremely difficult to treat, sometimes leading to chronic and debilitating symptoms, long-term disability and even death in rare cases. Lyme disease starts when bacteria are injected into the skin and the bacteria spread from there.

“We hope that this tester will provide accurate results faster — before Lyme disease spreads to other organs in our body,” Ignaszak said.

The key, she says, is to detect the actual bacteria, rather than the immune response.

“This is a urinalysis test, which does not rely on antibody detection as in the current clinical methods for Lyme testing,” she added. 

“The current clinical tests are far from perfect. False-positive results can arise from other bacterial infections or pre-existing bacterial antibodies, similarly false-negative results from premature testing before antibody development below the diagnostic threshold.”

Better diagnostic tools urgently needed

Finding better diagnostic tools is all the more urgent because the number of Lyme disease cases is skyrocketing worldwide. In North America, it’s increasing by “more than tenfold over the past decade,” Ignaszak writes in her research brief.

“In southern Canada, higher temperatures have been identified as the most significant factor determining environmental suitability for the establishment of the ticks that cause Lyme disease. Milder and shorter winters are linked to the northern spread of wild mice, reservoir hosts for Lyme disease pathogens,” she states.

Lloyd, a professor of biology at Mount Allison University in New Brunswick, is providing the bacteriological material to test the biosensor. 

She says organizations like the Canadian Lyme Disease Foundation have a central role to play in pushing research forward. 

“CanLyme represents the interests of Lyme disease patients and by taking a patient-first approach, researchers do the kind of research that really matters to Canadians,” Lloyd said.

If the study, which is funded by the Canadian Institutes of Health Research, the New Brunswick Innovation Foundation, the New Brunswick Health Research Foundation and the Natural Sciences and Engineering Research Council – Canada Graduate Scholarships, determines the biosensor can do everything Lloyd and Ignaszak hope it can, there are several more steps they will have to take.

Device could take years to come to market

Ignaszak says the device would have to go through clinical trials and be subjected to regulatory approvals by Health Canada, the U.S. Food and Drug Administration and the European Union Medical Device Directive. Those approvals could take anywhere between 12 and 36 months.

Then, she says, the two researchers could either set up their own company to produce the sensor and market it or sell the licence to a well-established producer of medical devices.

“The second route has some advantages that could bring this tester to patients faster. A large company already has partnerships with distributors, experienced marketing teams, a solid pipeline of customers … and this could help accelerate commercialization,” Ignaszak said.

“There are still a few years of work for us to move this technology from the research laboratories to the patients.”