Fibben Kirby, Williams Evelyn Kendall, Roback John D, Lam Wilbur A, Alter David N
The Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology, Atlanta, Georgia, USA.
Children's Healthcare of Atlanta Scottish Rite Hospital, Atlanta, Georgia, USA.
Lab Chip. 2025 May 28;25(11):2566-2577. doi: 10.1039/d4lc00614c.
An overview of the evolving role of microfluidics within clinical laboratories and diagnostic settings. It explores how microfluidic technologies, initially envisioned to replace traditional lab practices, are instead integrating into established workflows. This integration is driven by advancements in miniaturization and automation, enhancing efficiency and expanding testing capabilities. Regulatory frameworks such as CLIA and FDA oversight shape the landscape for microfluidic adoption, emphasizing the need for rigorous validation and compliance. The total testing process (TTP) framework underscores the critical phases-pre-analytical, analytical, and post-analytical-where microfluidics must conform with to ensure accuracy and reliability in diagnostic outcomes. Automation emerges as pivotal by streamlining workflows and reducing errors, particularly in sample handling and result interpretation. Challenges persist including the complex categorization of tests and the push for tighter regulation of laboratory developed tests (LDTs). The challenges necessitate collaboration between researchers, clinicians, and regulatory bodies. This review highlights how automation and integration of microfluidic technologies in point-of-care settings are reshaping clinical diagnostics, offering rapid, personalized testing options while maintaining high standards of patient care. Despite advancements, mitigating diagnostic errors remains paramount, requiring continuous refinement of technologies and adherence to established clinical protocols. Ultimately, the successful integration of microfluidics into clinical laboratories hinges on balancing innovation with regulatory compliance, ensuring seamless usability and consistent diagnostic accuracy within existing healthcare infrastructures.
微流控技术在临床实验室和诊断环境中不断演变的作用概述。它探讨了微流控技术最初设想取代传统实验室操作，如今却如何融入既定工作流程。这种融合由小型化和自动化的进步推动，提高了效率并扩展了检测能力。诸如CLIA和FDA监管等框架塑造了微流控技术应用的格局，强调了严格验证和合规的必要性。总检测流程（TTP）框架强调了关键阶段——分析前、分析中和分析后，微流控技术必须在这些阶段符合要求，以确保诊断结果的准确性和可靠性。自动化通过简化工作流程和减少错误（尤其是在样本处理和结果解读方面）而成为关键因素。挑战依然存在，包括检测的复杂分类以及对实验室自建检测（LDTs）更严格监管的推动。这些挑战需要研究人员、临床医生和监管机构之间的合作。本综述强调了微流控技术在即时护理环境中的自动化和整合如何重塑临床诊断，提供快速、个性化的检测选择，同时维持高标准的患者护理。尽管取得了进展，但减少诊断错误仍然至关重要，需要不断改进技术并遵守既定的临床方案。最终，微流控技术成功融入临床实验室取决于在创新与监管合规之间取得平衡，确保在现有医疗基础设施内实现无缝可用性和一致的诊断准确性。
