Advances in Point-of-Care Infectious Disease Diagnostics: Integration of Technologies, Validation, Artificial Intelligence, and Regulatory Oversight

Point-of-care (POC) infectious disease diagnostics are reshaping global health by delivering rapid, decentralized, and clinically actionable results that link bedside testing to population-level surveillance. Valued at approximately USD 53 billion in 2024 and projected to nearly double by 2033, the global POC diagnostics market is driven by infectious disease assays and accelerated by innovations in molecular amplification, biosensors, microfluidics, and artificial intelligence (AI). This review integrates current evidence across technological, clinical, regulatory, and public health domains. Immunoassays remain the backbone of volume deployment, while molecular nucleic acid amplification tests (NAATs) and emerging CRISPR-based platforms achieve laboratory-grade sensitivity at the point of care. AI has transitioned from an experimental tool to an embedded analytical layer that enhances image interpretation, multiplex signal deconvolution, and automated quality control. Rigorous validation, including analytical accuracy, clinical performance in intended-use settings, and usability testing under CLIA guidance, remains central to ensuring reliability in decentralized environments. Regulatory frameworks are adapting in parallel: FDA's lifecycle oversight of AI-enabled devices, the European IVDR's expanded evidence requirements, and the WHO Prequalification all emphasize continuous post-market surveillance. From a public health perspective, POC diagnostics have improved early case detection, treatment initiation, and outbreak containment for HIV, tuberculosis, malaria, influenza, RSV, and COVID-19. Yet persistent challenges (including limited harmonization of standards, uneven reimbursement, and scarce real-world data from low- and middle-income countries) continue to constrain equitable adoption. POC infectious disease diagnostics are thus entering a pivotal phase of digitization and regulatory maturity. Addressing remaining gaps in validation, lifecycle monitoring, and implementation equity will determine whether these technologies achieve their full promise as clinical accelerators and as cornerstones of global infectious disease preparedness.