From Bench to Bedside: Translating Electrochemiluminescence Diagnostics to Point-of-Care Applications

Biosensors play an essential role in point-of-care testing (PoCT), enabling the detection of clinically relevant biomarkers near the patient site and in a lab-free manner using analytical techniques such as electrochemical, optical, and colorimetric methods. The translation of PoCT diagnostic devices from academic laboratories to end users requires a design-led approach and a holistic development pathway that extends beyond initial proof-of-concept validation. This transition demands the integration of multiple microsystems capable of encompassing the full spectrum of clinical laboratory processes, including intuitive user workflows, strong analytical performance, and robust clinical validation. In addition, successful translation necessitates consideration of market research, business models, cost economics, ergonomics, ethical implications, and regulatory compliance. Electrochemiluminescence (ECL) has emerged as a leading analytical technique for detecting trace amounts of target analytes with high accuracy and sensitivity. However, ECL-based PoCT diagnostics platforms face many of the same translational challenges, particularly when moving from benchtop instrumentation to a portable, standalone solution. Accordingly, portability or a reduced footprint in PoCT ECL diagnostic device design should not be viewed solely as physical miniaturization, but rather as the comprehensive integration of engineering solutions and market-driven trade-offs. Such an approach enables diagnostic performance comparable to standard laboratory equipment while adhering to clinical and regulatory standards. This perspective provides critical insight into the current landscape of portable ECL biosensing platforms developed in our work for PoCT diagnostic applications, with particular emphasis on commercialization challenges and real-world utility. The article traces the evolution of ECL systems from early stage laboratory prototypes to fully integrated portable and wearable platforms. The aim of this perspective is to identify key research gaps, current technical challenges, and future directions toward the development of commercially viable ECL-based PoCT diagnostics suitable for on-site detection in low-resource settings worldwide.