Diagnostica Stago, Inc.

ST Genesia | Diagnostica Stago, Inc.

Automated, walk away instrument platform for running thrombin generation tests on Platelet Poor Plasma by the Hemker method (research use only; not for use in diagnostic procedures)

Citations (2)


(1) Comparative analysis of thrombin generation platforms for patients with coagulation factor deficiencies: A comprehensive assessment.

Thrombosis research
March 05, 2025
Haisma B, Schols SEM, van Oerle RGM, Verbeek-Knobbe K, Hellenbrand D, Verwoerd EJ, Heubel-Moenen FCJI, Stroobants AK, Meijer D, Rijpma SR, Henskens YMC

Thrombin generation assays (TGAs) assess the overall functionality of the hemostatic system and thereby provide a reflection of the hemostatic capacity of patients with disorders in this system. Currently, four (semi-)automated TGA platforms are available: the Calibrated Automated Thrombogram, Nijmegen Hemostasis Assay, ST Genesia and Ceveron s100. In this study, we compared their performance for detecting patients with congenital single coagulation factor deficiencies.

(2) Multicenter analytical performance evaluation of the ST Genesia thrombin generation system.

Annales de biologie clinique
March 05, 2025
Talon L, Feriel J, Sinegre T, Lebreton A, Lecomte M, Hemar C

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

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ABOUT THE COMPANY

At Stago, we work with you to design a comprehensive hemostasis solution to fit the unique needs of your laboratory. Our unique approach focuses on improving patient outcomes and reducing the overall cost of care. Rest assured with reliable results from our standardized testing platforms. Expert support services combined with a complete menu of routine and specialty assays enable you to focus on your patients while we focus on you.