The Challenges of Developing Biosensors for Clinical Assessment: A Review

Emerging research in biosensors has attracted much attention worldwide, particularly in response to the recent pandemic outbreak of coronavirus disease 2019 (COVID-19). Nevertheless, initiating research in biosensing applied to the diagnosis of diseases is still challenging for researchers, be it in the preferences of biosensor platforms, selection of biomarkers, detection strategies, or other aspects (e.g., cutoff values) to fulfill the clinical purpose. There are two sides to the development of a diagnostic tool: the biosensor development side and the clinical side. From the development side, the research engineers seek the typical characteristics of a biosensor: sensitivity, selectivity, linearity, stability, and reproducibility. On the other side are the physicians that expect a diagnostic tool that provides fast acquisition of patient information to obtain an early diagnosis or an efficient patient stratification, which consequently allows for making assertive and efficient clinical decisions. The development of diagnostic devices always involves assay developer researchers working as pivots to bridge both sides whose role is to find detection strategies suitable to the clinical needs by understanding (1) the intended use of the technology and its basic principle and (2) the preferable type of test: qualitative or quantitative, sample matrix challenges, biomarker(s) threshold (cutoff value), and if the system requires a mono- or multiplex assay format. This review highlights the challenges for the development of biosensors for clinical assessment and its broad application in multidisciplinary fields. This review paper highlights the following biosensor technologies: magnetoresistive (MR)-based, transistor-based, quartz crystal microbalance (QCM), and optical-based biosensors. Its working mechanisms are discussed with their pros and cons. The article also gives an overview of the most critical parameters that are optimized by developing a diagnostic tool.

Automated summary

Emerging research in biosensors, particularly in response to the COVID-19 pandemic, has attracted global attention. Challenges remain for researchers in terms of biosensor platform preferences, biomarker selection, and detection strategies, while physicians seek fast and efficient diagnostic tools for early diagnosis and patient stratification.