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.

Highlights

  • Point-of-care (POC) biosensing devices for rapid diagnosis outside a clinical laboratory environment are expected to feature widely in future patient care (Jung et al, 2015; Weigl et al 2014)

  • Initial investigations were conducted to verify the performance of the device (POISED-5) as a signal generator under ideal operational conditions

  • Device resolution was established by comparing output and input waveforms when connected to the 1000 Ω test load, and both device-generated and ADCreceived sinusoids were symmetrical (Fig. 3a)

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Summary

Introduction

Point-of-care (POC) biosensing devices for rapid diagnosis outside a clinical laboratory environment are expected to feature widely in future patient care (Jung et al, 2015; Weigl et al 2014). Measuring impedances over more than one frequency is considered an advantage for certain applications, with commercially-available devices for microbiology (Ramirez et al 2009) and cervical screening (Leeson 2014). These bioimpedance methods apply electrical signals directly to patient tissue, or to patient samples in a laboratory, both of which require specialized medical equipment and training (Shaw 2016)

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