PB0094 - A Novel, Point-of-care (POC) Portable Meter & Disposable Card, Viscoelastic Coagulation Diagnostic Platform for Hemostasis Management with complete results including fibrinolysis in under 10 minutes

Background: The CoagCare, a viscoelastic hemostatic diagnostic platform, comprised of a portable POC meter and test disposables, is presented here. The multi-channel disposable card incorporates 4 highly-sensitive elements vibrating at high-frequency (1-10μm, in-plane motion, KHz) within 4 individual assay chambers, and measures the viscoelastic properties in a 15μl drop of blood, thus enabling the entire viscoelastometric (VEM) curve and parameters to be evaluated in under 10 minutes (Figure1a). Current viscoelastic systems are bulky, vibration-sensitive, labor-intensive laboratory instruments, requiring >200μl of sample and >20-30 minutes for a single measurement, far too long for effective and timely hemostasis management.

Aims: To demonstrate the feasibility of repeatably measuring the VEM curve & parameters and evaluating the measurement of a series of hemostatic parameters using the novel CoagCare system.

Methods: Citrated venous whole blood from normal subjects spiked with varying amounts of heparin (0-3IU/ml), tissue plasminogen activator (tPA,0-120ng/ml), and saline (0-85%) were tested on the CoagCare System using single-channel extrinsic disposables (tissue factor reagent, Figure1a), and the VEM curve and parameters were recorded in under 10 minutes.

Results: 6 VEM parameters extracted from the VEM curve demonstrated coefficient of variation (CV) better than current systems in the market (Figure1b). R seconds increased proportionally with increasing heparin concentration up to 3 IU/ml (Figure2a). Fibrinolysis parameters CL1 - % decrease in clot stiffness and LY1 - % increase in clot lysis after 1 minute decreased and increased, respectively, in the presence of 120 ng/ml of tPA (Figure2b). Finally, a proprietary Dilution Parameter was used to detect sample dilution up to 85% in real-time using a threshold cut-off (Figure2c).

Conclusion(s): CoagCare successfully demonstrated the capability to repeatably generate the VEM curve and parameters in under 10 minutes, thus enabling rapid, bedside diagnostics for fast and efficient clinical management. The ability to measure a series of clinically relevant hemostatic parameters was also demonstrated.