Abstract
Recent advances in technologies for biosensor integration in mobile or wearable devices have highlighted the need for the definition of proper validation procedures and technical standards that enable testing, verification and validation of the overall performance of these solutions. Thus, reliable assessment—in terms of limits of detection/quantitation, linearity, range, analytical and diagnostic sensitivity/specificity, accuracy, repeatability, reproducibility, cross-reactivity, diagnostic efficiency, and positive/negative prediction—still represents the most critical and challenging aspect required to progress beyond the status of feasibility studies. Considering this picture, this work aims to review and discuss the literature referring to the available methods and criteria reported in the assessment of the performance of point-of-care testing (PoCT) devices within their specific applications. In particular, without losing generality, we focused on mobile or wearable systems able to analyze human sweat. In performing this review, the focus was on the main challenges and trends underlined in the literature, in order to provide specific hints that can be used to set shared procedures and improve the overall reliability of the identified solutions, addressing the importance of sample management, the sensing components, and the electronics. This review can contribute to supporting an effective validation of mobile or wearable PoCT devices and thus to spreading the use of reliable approaches outside hospitals and clinical laboratories.
Highlights
Recent advances in nanotechnologies, microfluidics, printed electronics, additive manufacturing, and biomaterials have brought about a significant improvement in the integration of sensing elements within wearable devices for point-of-care testing (PoCT) applications [1]
This review aims to provide a deep insight into the main validation procedures adopted to assess the metrological characteristics of electrochemical PoCT systems
Emerging from this review is a lack of procedure standardization and the absence of clear scientific references able to explain why the validation protocol was organized in that specific way
Summary
Microfluidics, printed electronics, additive manufacturing, and biomaterials have brought about a significant improvement in the integration of sensing elements within wearable devices for point-of-care testing (PoCT) applications [1] These technological evolutions contributed to the design of complete integrated systems, including the specific biosensing components and the sample treatment and distribution solutions, and the overall electronics [2]. This efficient integration allows these devices to work in a standalone modality and perform all the steps required to obtain a reliable detection of specific analytes, including sample collection and result interpretation [3].
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