Current and emerging trends in point-of-care technology and strategies for clinical validation and implementation

Abstract

BACKGROUND: Point-of-care technology (POCT) provides actionable information at the site of care to allow rapid clinical decision-making. With healthcare emphasis shifting toward precision medicine, population health, and chronic disease management, the potential impact of POCT continues to grow, and several prominent POCT trends have emerged or strengthened in the last decade. CONTENT: This review summarizes current and emerging trends in POCT, including technologies approved or cleared by the Food and Drug Administration or in development. Technologies included have either impacted existing clinical diagnostics applications (e.g., continuous monitoring and targeted nucleic acid testing) or are likely to impact diagnostics delivery in the near future. The focus is limited to in vitro diagnostics applications, although in some sections, technologies beyond in vitro diagnostics are also included given the commonalities (e.g., ultrasound plug-ins for smart phones). For technologies in development (e.g., wearables, noninvasive testing, mass spectrometry and nuclear magnetic resonance, paper-based diagnostics, nanopore-based devices, and digital microfluidics), we also discuss their potential clinical applications and provide perspectives on strategies beyond technological and analytical proof of concept, with the end goal of clinical implementation and impact. SUMMARY: The field of POCT has witnessed strong growth over the past decade, as evidenced by new clinical or consumer products or research and development directions. Combined with the appropriate strategies for clinical needs assessment, validation, and implementation, these and future POCTs may significantly impact care delivery and associated outcomes and costs.