PERSPECTIVE article

Front. Sens., 28 August 2025

Sec. Biosensors

Volume 6 - 2025 | https://doi.org/10.3389/fsens.2025.1641221

Challenges in the application of biosensor technology in the clinical biochemistry laboratory

  • Department of Chemistry, University of Toronto, Toronto, ON, Canada

Abstract

A biosensor device involves the transduction of a surface-oriented biochemical interaction into an electrical signal. This structure offers the potential for obtaining highly specific signals for the assay of bioanalytical targets in a rapid and cost-effective manner. These devices drive a rapidly expanding global market with notable contributions to analysis of blood glucose levels and great potential in the field of personalized medicine. However, some reluctance remains in the application of biosensors in clinical biochemistry laboratories. This article explores these challenges in attempts to highlight opportunities for improvement.

The biosensor and its marketplace

The biosensor device involves the transduction of a surface-oriented biochemical interaction into an electrical signal. The structure offers the potential for obtaining highly specific signals for the assay of bioanalytical targets in a rapid and cost-effective manner. A wide variety of technologies have been employed in terms of transduction including those based on electrochemistry (viz. amperometry, potentiometry, conductimetry, impedimetry, and voltammetry), optical systems such as surface plasmon resonance and chemiluminescent-based biosensors, and mass-sensitive biosensors including the piezoelectric quartz crystal microbalance and surface acoustic wave sensors. The method of detection is selected based on a variety of factors. These factors include the type of analyte, sensitivity requirements, risk of matrix interference, and desired speed of detection. A wide plethora of applications have been introduced including monitoring and assays in environmental analysis, food safety, industrial processes, drug discovery, and the subject matter of this opinion piece, medical science.

The scientific literature has shown a growing interest in biosensors over many years. As illustrated in Figure 1, the earliest publication on biosensors dates back to 1979. In 2024 alone, 4,967 papers related to biosensors were published and as of mid-2025, 3,871 articles on biosensors have been released. The data in Figure 1 reveals an average annual growth rate in publications of 21.3%, suggesting a steady expansion in the field of biosensors. According to Web of Science (), there are 18 journals dedicated to biosensor research, with Biosensors and Bioelectronics having the highest impact factor of 10.61 as of 2021. Beyond journal articles, biosensors are widely discussed in books and book chapters. One notable recent publication is Biosensors: Fundamentals, Emerging Technologies, and Applications by published by Taylor & Francis in 2022. This book provides an in-depth exploration of the biosensor market, covering fundamental principles and advancements in the field.

FIGURE 1

).

With regard to its marketplace, the Biosensor Market Report dated April 2021 reveals the estimated market size of biosensors is 25.5 billion USD dollars with estimated growth of an additional 36.7 billion USD dollars by . This data encompasses biosensor applications among point-of-care, environmental monitoring, food and beverage, and biodefense industries. The report suggests that there is some market reluctance in adopting new practices, more on this will be discussed in this paper. However, it is forecasted that wearable biosensor devices will continue to rise in popularity, promoting complete patient care and personalized medicine. As would be expected, developments in glucose detection would still appear to dominate the marketplace.

Applications of biosensor technology: point-of-care testing versus typical clinical biochemistry laboratories

In the medical sector, the biosensor device, in general terms, can be thought of being employed in two distinct arenas, that of point-of-care (POC) assays, and secondly clinical laboratory analysis. That said, some hospital facilities also conduct POC determinations. The former involves potential use in the home, hospital bedside, and doctor’s office. The legendary glucose assay, pregnancy, and COVID-19 tests are notable examples of successful commercial biosensors, enabling self-monitoring through their prompt response, ease-of-use, portability, low cost, small sample volume requirements, and disposable nature (; ; ; ; ; ).

It is the potential application of biosensor devices in the clinical biochemistry operation that is the focus of this perspective. Here, we take a brief look at a typical laboratory which is based in a Province of Ontario-hospital, where it is considered that 75% of medical decisions are based on the results obtained. The laboratory is staffed as follows: 22 pathologists, 3 clinical biochemists, 1 mass spectrometry assay specialist, 1 molecular assay specialist, 4 microbiologists, 2 hematologists (one oversees transfusion medicine), 1 hemato-pathologist, 5 managers (one for each division plus quality), 70 medical laboratory technicians (MLAs for phlebotomy, etc.) and 140 medical laboratory technologists. This facility conducts approximately 5 million assays annually in the areas of biochemistry, transfusion medicine, hematology, microbiology, pathology, and molecular biology. Biochemistry incorporates both diagnostic and therapeutic assays in blood, urine, and other body fluids. Transfusion medicine deals with blood donation, hematology looks at cell blood disorders while microbiology examines the presence of bacteria, fungi, and viruses in biological fluid. Pathology involves histology and cytology, often for cancer determinations. Finally, molecular biology deals with DNA and RNA assays. The extensive variety of tests requested over recent years, as an example, are depicted in Figure 2. As expected, the bulk of these lies in the biochemistry area, which incredibly includes approximately 2000 different species, with thyroid stimulating hormone (TSH) being the “winner.”

FIGURE 2

Biosensor technology and the clinical biochemistry operation

As specified above, the typical clinical biochemistry laboratory is a dedicated space for analyzing a wide variety of biological samples involving highly trained personnel and specialized tools that are often automated or robotic (; ; ). Any new technology under consideration to improve and disrupt these existing methods must overcome the main challenges of validation, cost, and regulation (Figure 3). These considerable time-consuming challenges have clearly, in our opinion, been responsible for hindering the widespread adoption of biosensors in the typical hospital (or commercial private) clinical laboratory. We further consider these issues below.

FIGURE 3

It is a reality of biosensor research, especially in academic laboratories, that there is a focus on sensitivity, selectivity, specificity, limits of detection and quantification, calibration curves, robustness, accuracy, precision, and stability (; ). However, “routine” use of biosensor technology to assay real clinical samples such as serum, saliva, and urine is far less common (). A major critical factor in ensuring the clinical relevance of a biosensor’s data is the minimization of interferences from non-specific adsorption (NSA) (; ) Avoidance of this phenomenon, often termed fouling by the engineering community, has not figured prominently at least as it pertains to operation on real clinical samples. A solution would clearly require tandem development of probe and anti-fouling surface chemistry.

An additional issue is the pragmatic question of whether introduced biosensor technology can replace entrenched, existing methodology from the cost per assay standpoint (; ; ), rather than simply acting as a further analytical approach. In this regard, the biosensor must be capable of dealing with sample throughput, whether it means processing a high volume of samples daily or only a few per year. Since automation is common in clinical laboratories, substantial financial investment would be mandatory with respect to the incorporation of sensor signalling technology (). From a practical point of view, it may be advisable to introduce biosensors for detection and assay of less common or rare diseases, where routine analysis and automation are unnecessary and clinical diagnostic tools are currently limited or lacking. One relevant recent example of this approach would be the identification of microRNAs associated with early-stage diseases, which presents a promising opportunity for their clinical detection using biosensors (; ; ).

Assuming that a clinically acceptable biosensor device can be produced, there is the essential issue that the technology will require necessary regulatory approval from appropriate jurisdictions (; ; ). Regulatory requirements for clinical applications are far more stringent than those for commercial use, which may be a key factor contributing to the more rapid market adoption of point-of-care devices compared to biosensors designed for clinical laboratories. An interesting feature of this aspect is that the clinical community is regarded to be particularly conservative as it pertains to the introduction of new technologies.

Final comment

On a more optimistic note, the possibility of biosensors to offer rapid, automatable, real-time detection with high sensitivity and antifouling capability holds tremendous potential to play a transformative role in future clinical biochemistry laboratories. As they become ubiquitous across the healthcare industry, biosensors could disrupt traditional diagnostic and prognostic methods, bridging the gap between innovative technology and traditional centralized laboratory analysis. The growing adoption of commercial biosensors in the coming decades may drive greater interest into integrating biosensors in clinical laboratory operations. Further research advancements, coupled with collaborative efforts with regulatory agencies, can help establish biosensors as standard clinical tools. Biosensor technology will ultimately strengthen public health and healthcare systems, revolutionizing disease identification, monitoring, and treatment.

Statements

Data availability statement

The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.

Author contributions

KD: Writing – original draft, Investigation, Writing – review and editing, Formal Analysis, Conceptualization. LN: Conceptualization, Writing – original draft, Writing – review and editing, Formal Analysis. MT: Writing – original draft, Resources, Conceptualization, Writing – review and editing.

Funding

The author(s) declare that no financial support was received for the research and/or publication of this article.

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Generative AI statement

The author(s) declare that no Generative AI was used in the creation of this manuscript.

Any alternative text (alt text) provided alongside figures in this article has been generated by Frontiers with the support of artificial intelligence and reasonable efforts have been made to ensure accuracy, including review by the authors wherever possible. If you identify any issues, please contact us.

Publisher’s note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

References

Summary

Keywords

biosensors, clinical biochemistry, critical appraisal, public healh, non-specific adsorption

Citation

Davoudian K, Nemtsov L and Thompson M (2025) Challenges in the application of biosensor technology in the clinical biochemistry laboratory. Front. Sens. 6:1641221. doi: 10.3389/fsens.2025.1641221

Received

04 June 2025

Accepted

14 August 2025

Published

28 August 2025

Volume

6 - 2025

Edited by

Raja Chinnappan, Alfaisal University, Saudi Arabia

Reviewed by

Mohana Marimuthu, Innovaspark, India

Muhammad Sheraz, Northwestern Polytechnical University, China

Updates

Copyright

© 2025 Davoudian, Nemtsov and Thompson.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Michael Thompson,

Disclaimer

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

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