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.

Background and Aim: Aflatoxins are metabolites of molds that exert potentially toxic effect on animals and humans. This study aimed to investigate the occurrence of aflatoxin M1 (AFM1) in raw cow milk collected during 1 year (2016-2017) from different regions of Algeria and risk factors associated with the contamination. Materials and Methods: During the survey period, 84 samples of raw milk were collected in three regions of Algeria (northeast, north center, and northwest) during four seasons. AFM1 levels were analyzed by competitive enzyme-linked immunosorbent assay. Results: AFM1 was detected in 39 (46.43%) samples (total mean concentration, 71.92 ng/L; range, 95.59-557.22 ng/L). However, the AFM1 levels exceeded the maximum tolerance limit set by the Food and Drug Administration in the USA (500 ng/L) in only 1 sample (1.19%). Statistical analysis revealed significant differences (p<0.005) between AFM1 levels in milk samples collected in the spring and autumn. The mean AFM1 levels in samples collected in the spring were significantly higher than those in samples collected in autumn. Conclusion: The survey indicates that farmers involved in milk production should be made aware of the adverse effects of aflatoxin contamination in animal feed. A systematic control program of supplementary feedstuff for lactating cows should be introduced by the public health authorities.

Background: Point-of-care (POC) diagnostic devices deliver rapid, near-patient results that drive timely clinical decisions across diverse settings (from emergency departments to home care). Their decentralized deployment mandates a rigorous, multi-phase validation strategy to ensure analytical accuracy, clinical reliability, and real-world utility before both regulatory clearance and reimbursement. Content: We propose an expanded, integrated framework comprising 4 pillars: Analytical validity: Quantification of sensitivity, specificity, predictive values adjusted for prevalence, limits of detection, bias/imprecision, and reproducibility using Receiver Operating Characteristic (ROC) curve analysis, Bland–Altman comparison, Passing–Bablok/Deming regression, and nonparametric techniques for semiquantitative outputs. Clinical validity: Demonstration of substantial equivalence via FDA 510(k) (Class II), de novo (novel low/moderate risk), or premarket approval (PMA; Class III with Investigational Device Exemption (IDE)-supported pivotal trials) pathways, supported by prospective, multicenter clinical studies, and human-factors usability assessments in intended use environments. Clinical utility: Evidence of improved patient care from outcome-based trials (e.g., time-to-treatment and readmission rates), health-economic analyses (cost per quality-adjusted life year and budget-impact models), and patient-reported outcome measures capturing usability, satisfaction, and adherence. Regulatory alignment: Harmonization of FDA and Health Canada requirements, including ISO 14971 risk management, post-market surveillance (21 CFR 820; Medical Device Licence [MDL] vigilance), to streamline market access and payer coverage decisions. Summary: This comprehensive, staged validation pathway, from analytical benchmarks through clinical performance and utility to regulatory and reimbursement strategies, provides a practical roadmap for innovators, clinicians, and regulators. Embedding real-world evidence and coordinating US and Canadian frameworks accelerates the adoption of safe, effective, and value-based POC diagnostics, fostering better patient outcomes, and supporting modern precision medicine.