From Lab-on-a-Chip to Lab-on-a-Chip-in-the-Lab: a perspective of clinical laboratory medicine for the microtechnologist.

Abstract

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.