Functional Materials for Molecular POCT in Infectious Disease Detection: Advances and Regulatory Perspectives

On-site nucleic acid analysis for infectious diseases can be rapidly achieved through molecular point-of-care testing (molecular POCT), which plays an indispensable role in early pathogen identification, timely clinical intervention, and public health emergency response. Performance improvements in such systems are largely driven by innovations in functional materials that refine nucleic acid extraction, amplification, and signal output. This article reviews recent developments in functional materials deployed in molecular POCT, with emphasis on nucleic acid capture matrices, amplification-promoting agents, and signal transduction components. From a medical device regulatory standpoint, we examine how material characteristics shape key analytical indicators, including sensitivity and specificity, and discuss critical risks such as off-target amplification and batch inconsistency. Finally, we outline future directions, highlighting cross-disciplinary cooperation to reconcile technological innovation with risk control for translating advanced materials into high-performance molecular POCT products.