Multicenter analytical performance evaluation of the ST Genesia thrombin generation system

• DOI: 10.1684/abc.2025.1942
• Publication Date: 2025-02-19T15:37:21Z
• Authors: Laurie Talon; Joffrey Feriel; Thomas Sinegre; Aurélien Lebreton; Mélanie Lecomte; Claire Hemar
• Keywords: Thrombin Generation

Available data on the potential use of thrombin generation (TG) assays in clinical practice is promising but larger studies involving several centers are needed to confirm this added-value for purposes. The objective evaluation was assess analytical performances ST Genesia using STG-ThromboScreen, STG-BleedScreen, and STG-DrugScreen reagents across three support its multicenter studies. Repeatability reproducibility have been evaluated commercial plasmas quality control (QC) samples. Accuracy assessed by calculating QC biases from manufacturer's assigned values. Frozen plasma samples healthy donors patients having thrombophilia, hemorrhagic disorders, or taking anticoagulants allowed comparison TG parameters between analyzers two French centers. CVs were respectively below 5% 10% whatever reagent sample used. later fell under 6% after normalization. Mean observed values provided manufacturer less than most parameters. We found a good agreement all evaluating Relative bias combination except Peak height (+14.2%), ETP (+7.3%), inhibition (-12.0%) STG-ThromboScreen. satisfactory repeatability, reproducibility, accuracy, inter-laboratory variability available centers, supporting trials.