Biosensor technologies are increasingly seen as important tools in healthcare diagnostics, especially for point-of-care (POC) and decentralized testing. A systematic comparison of sensing methods, the scattered integration of nanomaterials into unified designs, and the neglect of real-world usability factors like device miniaturization, user interface integration, and data sharing continue to be issues despite rapid advancements. This review critically examines recent progress in electrochemical, fluorescence, and colorimetric methods, with a special focus on signal amplification strategies using nanomaterials and their feasibility for real-world use. A structured literature survey was conducted using Web of Science, Scopus, and Google Scholar, covering publications from 2015 to 2025. The review aims to compare analytical performance, material innovations, challenges with reproducibility, and regulatory aspects, including clinical translation. Emerging material platforms such as metal–organic frameworks, carbon dots, MXene composites, and nanozymes are discussed within their respective sensing methods to avoid confusion. Additionally, regulatory pathways set by the U.S. Food and Drug Administration and the European Medicines Agency are analyzed to highlight challenges in commercialization. The review concludes by identifying research gaps related to long-term stability, large-cohort validation, scalability, and standardization, thereby outlining future directions for clinically deployable next-generation biosensors.
Chhillar et al. (Tue,) studied this question.