Rapid hemostasis assessment is essential for managing acute coagulopathy, guiding anticoagulant therapy, and monitoring cardiac surgery patients. Although viscoelastic testing provides valuable guidance for early intervention, its widespread adoption is constrained by large blood usage (~2 mL), prolonged turnaround times (several hours), long assay durations (~25–40 min), and high costs. To overcome these limitations, we developed an innovative, all-in-one magnetoelastic (ME) sensing chip that enables systematic coagulation kinetics monitoring using only 46 μL of whole blood within 15 min. Featuring prepackaged lyophilized reagents and pumpless blood loading, this user-friendly chip is highly cost-effective for disposable use. The experimental results demonstrated good reproducibility for on-chip extrinsic coagulation activation, with clotting parameters maintaining coefficients of variation under 10%. Furthermore, clotting parameters derived from heparin monitoring results exhibited a strong linear correlation that compares favorably with the clinical standard (r = 0.986). Finally, sensitivity evaluation toward various blood components validated the sensor’s dual-mode characterization strategy for identifying coagulation factors and fibrin-related coagulopathies. The proposed ME sensing chip holds promise for bedside testing and flexible, on-demand coagulation monitoring across diverse clinical scenarios.
Background: Thromboelastography (TEG) assesses global coagulation, but its sensitivity for factor deficiencies is reportedly low and may depend on the contact activator. However, the differential TEG sensitivity of contact activators for individual factor deficiencies in whole blood containing platelets and red blood cells remains unclear. This study assessed the relative sensitivity of three contact activators for detecting single coagulation factor deficiencies in reconstituted whole-blood samples using TEG. Methods: Reconstituted whole-blood samples with graded activities of FII, FV, FVIII, FIX, FX, FXI, and FXII were prepared by mixing platelets, plasma, and red blood cells, and analyzed by TEG using kaolin-, ellagic acid-, and colloidal silica-based activators (KL, EA and CS). Relative sensitivity was assessed via: (1) the factor activity at which R time first showed a statistically significant prolongation; (2) a novel metric, Sensitivity for Detecting Factor Deficiencies (SDFD), defined as the normalized relative change in R time, enabling comparison without reference ranges. Results: KL showed the broadest and highest sensitivity, detecting significant prolongation at the mildest deficiency levels for most factors. EA showed intermediate-to-high sensitivity and the highest sensitivity for FXII. CS was the least sensitive except for FV. Notably, the activity threshold of KL for exceeding the reference range was substantially lower than that for statistical significance. Conclusions: The sensitivity of TEG to coagulation factor deficiencies is dependent on the contact activator. KL showed the highest overall sensitivity to factor deficiencies, while EA showed the highest sensitivity for FXII deficiency under the conditions of this study. R time of KL can be significantly prolonged yet still stay within the reference range. This mismatch calls for more sensitive TEG reagents and stricter ranges.