Organ-on-a-chip platforms for disease modeling and in vitro diagnostic applications.

Organ-on-a-Chip (OoC) systems, as microphysiological models integrating microfluidic engineering, 3D tissue construction, and sensing technologies, can faithfully recapitulate the barrier functions, dynamic microenvironments, and inter-tissue crosstalk of human organs. They effectively address the inherent limitations of traditional 2D cell cultures and animal models in in vitro diagnostics (IVD), offering a novel avenue to tackle the high failure rate of candidate drugs and biomarkers in clinical translation. This review systematically summarizes the technological advances and application practices of OoC in the IVD field, covering core construction technologies (microfluidic regulation, cell and tissue engineering, material innovation), the integrated optimization of the "online real-time monitoring-offline in-depth analysis" dual-detection system, and typical applications in disease modeling, biomarker screening, drug toxicity evaluation, and personalized diagnosis. It further explores Multi-Organ-Chip (MOC) systems and Artificial Intelligence (AI) empowerment, analyzes core bottlenecks including insufficient physiological complexity, lack of standardization, and barriers to clinical translation and industrialization, and prospects future directions from technological optimization, standardization establishment, and regulatory pathway exploration. By focusing on the IVD-oriented perspective, this review aims to provide theoretical references and practical guidance for the transformation of OoC from laboratory research to clinical IVD tools.