From Lab to Clinic: Patient‐Based Validation of Microfluidic‐Isothermal Amplification Devices for Early Disease Diagnosis

ABSTRACT

Early diagnosis markedly improves therapeutic efficacy, recovery, and disease control. Microfluidic platforms based on isothermal nucleic acid amplification enable sensitive, rapid, and low‐volume detection of disease markers. This review provides a critical analysis of the integration of isothermal amplification techniques with microfluidic platforms for early detection of diseases, including cancer, infectious diseases, and genetic disorders. Key isothermal amplification methods—including loop‐mediated isothermal amplification (LAMP), recombinase polymerase amplification (RPA), and helicase‐dependent amplification (HDA)—are evaluated in terms of their underlying mechanisms, advantages, and limitations. The complementary combination of isothermal nucleic acid amplification with microfluidics represents a promising approach to enhance the early diagnostic of clinical samples. Importantly, the translation of these platforms into clinical practice has been validated through patient‐based studies and clinical trials, confirming their reliability as point‐of‐care diagnostics. Ongoing research continues to refine these technologies, resulting in several commercial products that address evolving diagnostic needs. Furthermore, the integration of artificial intelligence and machine learning approaches for automated signal interpretation and accelerated diagnostics is discussed. This review summarizes the current landscape of point‐of‐care devices and highlights strategies to enhance clinical outcomes, improve patient validation, and address current limitations.