From Analytical Performance to Point-of-Care Readiness: A PRISMA 2020 Systematic Review of Wearable and Microneedle Electrochemical Biosensors for Disease-Related Biomarker Detection

Introduction: Wearable and microneedle-based electrochemical biosensors are increasingly proposed as minimally invasive platforms for point-of-care detection of disease-related biomarkers. However, the extent to which reported devices move beyond analytical proof-of-concept toward diagnostically usable, clinically translatable systems remains insufficiently synthesized.

Methods: A PRISMA 2020-guided systematic review was designed to evaluate wearable and microneedle electrochemical biosensors for point-of-care biomarker detection. PubMed, Scopus, and Web of Science were searched for studies published from 2020 to 2026 using terms related to “wearable biosensor,” “microneedle,” “electrochemical sensing,” “point-of-care diagnostics,” and “biomarker detection.” Eligible studies reported original experimental biosensor platforms with quantitative analytical performance data and a clear diagnostic or disease-monitoring application. Reviews, purely theoretical studies, non-biological sensors, and studies lacking performance metrics were excluded. Extracted variables included target biomarker, biofluid or sample matrix, transduction strategy, limit of detection, linear range, selectivity, real-sample validation, device integration, and point-of-care readiness indicators.

Methods: A PRISMA 2020-guided systematic review was conducted to evaluate wearable and microneedle electrochemical sensors for point-of-care biomarker detection. PubMed, Scopus, and Web of Science were searched for studies published between 2020 and 2026 using terms related to wearable sensors, microneedles, electrochemical sensing, interstitial fluid, sweat, point-of-care diagnostics, and biomarker detection. Eligible studies reported original experimental sensor platforms with quantitative analytical performance data and a clear diagnostic or disease-monitoring application. Reviews, purely theoretical studies, non-biological sensors, and studies lacking analytical performance metrics were excluded.

Conclusions: Current wearable and microneedle electrochemical biosensors show strong analytical potential for point-of-care diagnostics, but translational readiness remains limited by insufficient real-sample validation, device-level integration, standardized performance reporting, and clinically relevant benchmarking. This systematic review identifies the key evidence gaps that must be addressed before these platforms can progress from laboratory biosensing prototypes to reliable diagnostic tools.