Back to Search Start Over

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

Authors :
Foulon-Pinto G
Jourdi G
Perrin J
Abdoul J
Paris G
Gouin-Thibault I
Curis E
Lecompte T
Siguret V
Source :
International journal of laboratory hematology [Int J Lab Hematol] 2021 Aug; Vol. 43 (4), pp. 821-830. Date of Electronic Publication: 2020 Dec 28.
Publication Year :
2021

Abstract

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.<br />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.<br />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%).<br />Conclusion: ST Genesia <superscript>®</superscript> 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.<br /> (© 2020 John Wiley & Sons Ltd.)

Details

Language :
English
ISSN :
1751-553X
Volume :
43
Issue :
4
Database :
MEDLINE
Journal :
International journal of laboratory hematology
Publication Type :
Academic Journal
Accession number :
33369212
Full Text :
https://doi.org/10.1111/ijlh.13443