This review critically summarizes the microneedle diagnostic systems by comprehensively considering the microneedle architecture, material and polymer properties, mechanical design, sensing modality, disease‐specific biomarker requirements and translational performance.
Abstract
Conventional blood‐based diagnostics provide essential clinical information but can be less suitable for frequent or continuous biomarker monitoring because they generally require repeated invasive sampling and laboratory‐based analysis. Microneedle platforms provide minimally invasive access to dermal interstitial fluid (ISF) and can couple transdermal sampling with on‐needle or in situ sensing. This review critically summarizes the microneedle diagnostic systems by comprehensively considering the microneedle architecture, material and polymer properties, mechanical design, sensing modality, disease‐specific biomarker requirements and translational performance. Solid, hollow, coated, dissolving, and hydrogel microneedles are discussed together with recent advances in polymer structure–property engineering and 3D‐printed microneedle platforms. Electrical/electrochemical, optical, and Raman‐based sensing strategies are comparatively evaluated, followed by their applications in metabolic, oncological, inflammatory, allergic, stress‐related, and renal disorders. Particular attention is given to the trade‐offs among mechanical reliability, ISF transport, analytical sensitivity, biofouling, signal stability, manufacturing reproducibility, and clinical validation. Finally, scalable manufacturing, regulatory translation, wearable integration, and artificial‐intelligence‐assisted analysis are discussed as key requirements for moving microneedle diagnostics from proof‐of‐concept devices toward reliable personalized and decentralized healthcare.
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