Lyme disease is as hard to detect as a ‘needle in a haystack.’ But a new breakthrough could change that

The bacterium that causes Lyme disease is a stealthy predator that can hide in patients’ bodies for weeks, months, even years, and researchers say detecting it can be like finding “a needle in a haystack” – but Canadian scientists are developing tools that can diagnose the country’s most common vector-borne illness much earlier and much faster.

At the G. Magnotta Lab on the campus of the University of Guelph in southern Ontario, researchers have announced a breakthrough: biosensors that can detect minuscule fragments of the pathogen itself in a tiny drop of blood.

The details appear in a paper published by the journal ACS Sensors in late February. 

“The sensing is performed directly in unprocessed blood and without the conventionally employed premeasurement washings, rendering the proposed technology suitable for a fast, simple, self-use diagnostic kit for Lyme disease,” the paper states. 

Dr. Melanie Wills, the lab’s director, says the device will be a major improvement over testing methods now in use in Canada, because those tests look for the immune response to the bacterial infection, not biomarkers from the bacteria itself.

“It is so exquisitely sensitive that it is much better at finding that needle, and essentially screening a lot of hay,” Wills says.

”So the needle-in-a-haystack problem is effectively solved by being able to look for much, much smaller amounts of the pathogen material.”

Wills says the large international interdisciplinary team began this project not long after the lab was established in 2017 by the G. Magnotta Foundation to find better ways to test and treat Lyme disease. She says it’s taken years to get the device to this point.

There’s an urgent need for better diagnostic tests that can pick up the presence of Borrelia burgdorferi, the bacterium that causes Lyme disease. That’s because case counts are soaring in Canada. Thanks to climate change, the ticks that spread the infection have rapidly gained a foothold in Nova Scotia, New Brunswick and the southern regions of Quebec, Ontario, Manitoba and B.C. Some estimates put the number of cases at 13 times the official Health Canada count of 27,463 between 2009 and 2024. 

The current two-step test is slow and prone to false negatives, meaning medical professionals often fail to catch the disease early. That can lead to debilitating chronic symptoms that can persist for years, and even result in death in some cases.

How the biosensor works

The device operates on somewhat the same principle as the instrument diabetics use to test their blood glucose levels. It’s an electrochemical sensor that uses the semiconductor and transistor technology that drives so many of the smart devices we now take for granted.

The sensor, designed by Dr. Gil Shalev of the Ben Gurion University of the Negev in Israel, is a tiny transistor tuned to detect a protein that originates on the surface of the Borrelia burgdorferi bacterium. It then translates that data into an electrical signal, says Dr. Vladimir Bamm, one of the senior research associates at the Magnotta Lab working on the project.

”The signal is sent to the computer and the computer can translate it into a ‘yes’ or ‘no’ response,” Bamm says.

One of the big advantages of the biosensor is that it requires only a very small blood sample, “even smaller than what you can get with a finger prick,” Bamm says.

”This blood is unprocessed … so we do not need to fractionate this blood … We can use the whole blood right away.”

That means medical professionals could use the biosensor to make a diagnosis “on the spot,” Bamm says, rather than waste precious time waiting for the results of an antibody test to come back from a lab.

Testing urine for Lyme disease

Wills and Bamm aren’t the only Canadian researchers hoping to use this technology to help Lyme disease patients.

Dr. Anna Ignaszak, of Brock University in St, Catharines, Ont., is continuing her work on a similar biosensor that can detect the bacteria in urine. 

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,” says Ignaszak, who serves on the Canadian Lyme Disease Foundation’s advisory council.

She adds that it would work with a “laptop, tablet, or cell phone through WiFi, Bluetooth or a conventional USB port.”

Ignaszak says her sensor now detects 200 Borrelia burgdorferi bacteria per millilitre of liquid. That might sound like a lot to laypeople but she cautions the device needs more refining.

“This detection limit is not yet sufficient for a reliable test,” she says.

“We are currently working to improve the sensor’s sensitivity to enable the detection of bacteria at much lower concentrations.”

She also says her team is working on enhancing the device to detect not just the bacterium, but proteins that originate on its surface along with other even more elusive biomarkers present in the urine of early Lyme disease patients. 

“This multi-recognition approach enhances both sensitivity and specificity by providing independent confirmation of active infection,” she says.

Biosensors years away from market

Although both devices are showing a lot of promise in the lab, the researchers testing them caution that they’re years away from showing up in hospitals, doctors’ offices and people’s homes.

“Everyone wants a timeline and we totally understand that,” Wills says.

“We can’t commit to a specific release date because we know how much research and development still has to go into this … We don’t want to give anyone false hope.”

Wills says even though the biosensor is small, the equipment the research team is using to read and analyze the signals is still “heavy lab infrastructure” they need to figure out how to miniaturize.

The team knows the potential is there to turn the system into a “portable point-of-care device,” she says.

”It is not there yet.”

For her part, Ignaszak says her biosensor will 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.

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