CNBTM-based electrochemical sensor for clinical studies

Because of its compact size, the sensor can be used in several settings, which can cut the detection time from hours to minutes. The sensor is now being evaluated with clinical samples from the Helsinki University Hospital. Canatu will present the new electrochemical sensor at COMPAMED High-Tech Forum, Printed Diagnostics and 3D Printing session on Monday 16th November.

Opioid analgesic misuse has risen significantly over the past two decades. According to WHO estimates, approximately 115,000 people died of opioid overdose in 2017 alone. Fast detection of concentrations of analgesics is critical for safe patient care. Currently, intoxication is diagnosed based on clinical signs and the concentrations are measured afterwards in a laboratory from blood samples drawn via venipuncture.

Obtaining whole blood samples can be challenging and requires high level of expertise. Samples are then sent away from the point of care, and hours or even days can pass before the results are ready while the care must continue without the needed information. Testing is confined to the laboratory because this standard mass spectrometry method requires bulky equipment and sample treatment that cannot be done elsewhere.

The new portable electrochemical device can detect a range of analgesics (such as opioids and acetaminophen) with high sensitivity and selectivity from small samples, such as a single blood drop. This enables the use of non-invasive capillary blood, urine and saliva in testing the concentrations of the analgesics. Because of its small size, the test can also be conducted at the point of care, such as at clinics, at home and remote areas where on-site testing and rapid results are critical for well-informed patient care.

“The new portable POC electrochemical sensor enables timely clinical decision making and better patient care. With fast test results, the physician can update the individual care plan and the medication on a timely manner,” said Professor Eija Kalso, Faculty of Medicine, University of Helsinki.

Canatu Carbon NanoBuds are ideal for the detection of analgesics because of their clean surface, large contact area with the analyte and high conductivity which contribute to strong signal and low detection limit. They are extremely versatile, which means the molecular structure can be tuned to maximise selectivity. Thanks to the self-filtering structure, CNBs havehigh resistance to fouling, which helps prevent electrode contamination by large molecules, such as proteins. Contamination can risk reliability by preventing contact with the analyte.

“Our Carbon NanoBud material innovation delivers value across industries. We are continuously on the lookout for new domains to help solve the world’s most critical challenges and enhance the process with our solutions. CNBs are amazingly versatile with virtually infinite application potentials. With medical diagnostics, we are embarking on an exciting journey with a meaningful purpose; to help cure the global opioid overdose crisis and save lives,” saaddedys Ilkka Varjos, CTO, Canatu Oy.

The clinical study design includes two phases. The first clinical study aims to validate test reliability and equivalence with a standard mass spectrometry laboratory method. 200 laboratory samples are collected from patients with suspected acetaminophen intoxication and tested for concentration applying both the new FEDOC method and the standard chromatographic method. The second clinical study compares test results of alternative sampling methods, namely venipuncture, capillary blood, urine, and saliva.

FEDOC is a two-year Research to Business project kicked off in June 2019, led by Aalto University and funded by Business Finland. Clinical studies started in July 2020. Canatu participates in the project as a proprietary supplier of the CNB -based sensors manufactured in Canatu’s mass production lines.