How to Assess the Measurement Performance of Mobile/Wearable Point-of-Care Testing Devices? A Systematic Review Addressing Sweat Analysis

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.