Abstract

Nowadays, analytical techniques are moving towards the development of smart biosensing strategies for the point-of-care accurate screening of disease biomarkers, such as human epididymis protein 4 (HE4), a recently discovered serum marker for early ovarian cancer diagnosis. In this context, the present work represents the first implementation of a competitive enzyme-labelled magneto-immunoassay exploiting a homemade IoT Wi-Fi cloud-based portable potentiostat for differential pulse voltammetry readout. The electrochemical device was specifically designed to be capable of autonomous calibration and data processing, switching between calibration, and measurement modes: in particular, firstly, a baseline estimation algorithm is applied for correct peak computation, then calibration function is built by interpolating data with a four-parameter logistic function. The calibration function parameters are stored on the cloud for inverse prediction to determine the concentration of unknown samples. Interpolation function calibration and concentration evaluation are performed directly on-board, thus reducing the power consumption. The analytical device was validated in human serum, demonstrating good sensing performance for analysis of HE4 with detection and quantitation limits in human serum of 3.5 and 29.2 pM, respectively, reaching the sensitivity that is required for diagnostic purposes, with high potential for applications as portable and smart diagnostic tool for point-of-care testing.

Highlights

  • Ovarian carcinoma (OC) is the leading cause of death from gynecological malignancy worldwide: it is generally asymptomatic in the early stage, so the majority of women with OC are not diagnosed until the disease is in an advanced stage, with an overall five-year relative survival rate that is generally in the 30–40% range [1,2]

  • These experiments were aimed at investigating the dynamic range for the concentrations of (i) human epididymis protein 4 (HE4) used for MBs functionalization and (ii) anti-HE4 used for the implementation of the immunocompetition

  • We proposed an innovative approach to address disease diagnosis and management through the integration of IoT home-made portable potentiostat with electrochemical

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Summary

Introduction

Ovarian carcinoma (OC) is the leading cause of death from gynecological malignancy worldwide: it is generally asymptomatic in the early stage, so the majority of women with OC are not diagnosed until the disease is in an advanced stage, with an overall five-year relative survival rate that is generally in the 30–40% range [1,2]. It is crucial to detect OC as early as possible to correctly identify the cancer stage for effective treatment options and to early distinguish malignant from benign pelvic mass by means of annual routine gynecological and pelvic examinations, as well as dedicated screening programmes In this context, noninvasive cancer detection at an early stage needs the identification of specific and sensitive biomarkers that are present at abnormal concentrations in body fluids, as well as the development of smart devices for analytical screening [3,4,5,6], in order to improve ovarian cancer survival rate [7]. Over the last years, a number of alternative OC biomarkers, especially for the predominant OC subtype, i.e. epithelial ovarian cancer (EOC), have been identified and studied, either alone or combined, to improve the effectiveness of early diagnostic strategies

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