Key result
The ST Genesia system demonstrated reliable measurement of thrombin generation with inter-series CVs <7% and good agreement with the CAT method, despite observed biases (PH: 16.4 ± 13.2%).
Why the study?
ST Genesia is a new automated system for standardized evaluation of thrombin generation, but data on its analytical performances are scarce.
Observational
The ST Genesia system provides reliable and standardized measurement of thrombin generation in plasma samples containing direct oral anticoagulants.
ST Genesia supports standardized thrombin generation testing in DOAC samples; leaves open clinical utility pending prospective validation.
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-studyNCT01627665) before and after rivaroxaban intake. RESULTS: For all dedicated quality control (QC) levels, inter-series coefficients of variations (CV) were <7% for temporal TG parameters, peak height (PH), and endogenous thrombin potential (ETP), whether results were normalized with a dedicated reference plasma STG-RefPlasma or not. Noteworthy, STG-RefPlasma used for normalization displayed substantially high PH and ETP. Mean biases between the observed and manufacturer's assigned QC values were mostly <7%. Both rivaroxaban/apixaban plasma concentrations were significantly associated with TG parameters. Finally, Bland-Altman plots showed a good agreement between ST Genesia-STG-ThromboScreen and CAT method within the explored range of values, although biases could be observed (PH: 16.4 ± 13.2%, ETP: 17.8 ± 11.9%). CONCLUSION: enables the reliable measurement of TG parameters in both in vitro and ex vivo xaban plasma samples using either STG-ThromboScreen or STG-DrugScreen according to xaban concentrations. The use of reference plasma, despite not completely reflecting a normal pooled plasma behavior, likely improves standardization and inter-laboratory comparisons.
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Foulon‐Pinto et al. (2020) conducted an observational in Healthy volunteers and spiked plasma samples. ST Genesia system vs. Calibrated Automated Thrombogram (CAT) method was evaluated on Inter-series coefficients of variations (CV) for temporal TG parameters, peak height (PH), and endogenous thrombin potential (ETP). The ST Genesia system demonstrated reliable measurement of thrombin generation with inter-series CVs <7% and good agreement with the CAT method, despite observed biases (PH: 16.4 ± 13.2%).
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