Abstract
Point-of-care medical devices offer the potential for rapid biomarker detection and reporting of medical conditions, thereby bypassing the requirements for offline clinical laboratory facilities in many cases. Label-free electrochemical techniques are suitable for use in handheld diagnostic devices due the inherent electronic detection modality and low requirement for processing reagents. While electrochemical impedance sensing is widely used in tissue analysis such as body composition measurement, its use in point-of-care patient testing is yet to be widely adopted. Here we have considered a number of issues currently limiting the translation of electrochemical impedance sensing into clinical biosensor devices. Specifically, we have addressed the current requirement for these sensors to be connected to an external processor by applying a minimum number of frequencies required for optimized biomarker detection, and subsequently delivering analytics within the measurement device. The POISED-5 device was evaluated using a sensor for the ovarian cancer biomarker cancer antigen 125 (CA125), demonstrating performance comparable to standard laboratory equipment, with direct interpretation of response signal amplitude substituting traditional impedance component calculation and model fitting.