Study of thrombin generation with St Genesia to evaluate xaban pharmacodynamics: Analytical performances over 18 months

Introduction ST Genesia is a new automated system enabling quantitative standardized evaluation of thrombin generation (TG), for example, in patients receiving anti‐Xa direct inhibitors (xabans). Data on its analytical performances are scarce. Methods Over an 18‐month period, repeatability, reproducibility, and accuracy were assessed using STG‐ThromboScreen (without or with thrombomodulin) or STG‐DrugScreen reagents (corresponding to intermediate/high tissue‐factor concentration, respectively), and controls. Furthermore, reproducibility was assessed using commercialized lyophilized and frozen normal pooled plasmas. Rivaroxaban and apixaban impacts on TG parameters were assessed using spiking experiments. Finally, a comparison with the Calibrated Automated Thrombogram method (CAT) (PPP reagent) was performed using plasma from healthy volunteers enrolled in the DRIVING‐studyNCT 01627665) before and after rivaroxaban intake. Results For all dedicated quality control (QC) levels, inter‐series coefficients of variations (CV) were