Automation in Platelet Function Testing: Current Challenges and Future Directions.

Platelet function testing is essential for diagnosing and managing platelet function disorders, but faces significant challenges due to complex protocols and variability in results. While light transmission aggregometry remains the gold standard for assessing platelet aggregation, it suffers from several limitations, including labor-intensive protocols, variability in reagents, and poor standardization. Over the decades, improvements such as lumi-aggregometry, which integrates granule secretion testing, and impedance whole-blood aggregometry, which simplifies sample handling, have addressed some of these challenges. Advanced granule secretion assays, including high-performance liquid chromatography and flow cytometry, have further enhanced diagnostic capabilities, although these techniques still depend on specialized expertise and expensive equipment. Recently, significant advancements have been made with automated aggregometers, such as the Sysmex CS series, and high-throughput 96-well plate assays, which improve consistency, throughput, and reproducibility. Nonetheless, further refinement in standardized reagents and consensus-driven protocols is required. Microfluidic technologies, exemplified by systems like the Total Thrombus Analysis System (T-TAS), incorporate physiological shear conditions and real-time thrombus formation assessment, providing enhanced diagnostic insights into platelet behavior. Despite their automation and clinical feasibility, these flow-based systems still require broader validation for routine clinical implementation. Further developments should prioritize integrating complementary assays, enhancing automation, and advancing miniaturization to improve standardization and diagnostic accuracy. Future technologies combined with artificial intelligence-based data interpretation hold the promise to transform platelet diagnostics, enabling personalized patient care. However, achieving widespread clinical adoption requires ongoing collaboration between clinicians, laboratories, industry, and regulatory bodies.