Innovations Thérapeutiques en Hémostase, Université de Paris, INSERM, Paris, France.
Service d'Hématologie Biologique, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
Int J Lab Hematol. 2021 Aug;43(4):821-830. doi: 10.1111/ijlh.13443. Epub 2020 Dec 28.
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.
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.
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%).
ST Genesia 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.
ST Genesia 是一种新的自动化系统，能够定量标准化地评估凝血酶生成 (TG)，例如在接受抗 Xa 直接抑制剂 (xabans) 的患者中。关于其分析性能的数据很少。
在 18 个月的时间里，使用 STG-ThromboScreen（无或有血栓调节蛋白）或 STG-DrugScreen 试剂（分别对应于中等/高组织因子浓度）以及对照品评估重复性、再现性和准确性。此外，使用商业化的冻干和冷冻正常混合血浆评估再现性。使用掺入实验评估利伐沙班和阿哌沙班对 TG 参数的影响。最后，使用健康志愿者的血浆（DRIVING 研究 NCT01627665）与 Calibrated Automated Thrombogram 方法 (CAT)（PPP 试剂）进行比较，该志愿者在服用利伐沙班前和后。
对于所有专用质量控制 (QC) 水平，时间 TG 参数、峰值高度 (PH) 和内源性凝血酶潜能 (ETP) 的组间变异系数 (CV) 均<7%，无论结果是否用专用参考血浆 STG-RefPlasma 进行归一化。值得注意的是，用于归一化的 STG-RefPlasma 显示出相当高的 PH 和 ETP。观察到的和制造商分配的 QC 值之间的平均偏差大多<7%。利伐沙班/阿哌沙班血浆浓度均与 TG 参数显著相关。最后，Bland-Altman 图显示在探索的范围内，ST Genesia-STG-ThromboScreen 和 CAT 方法之间具有良好的一致性，尽管存在偏差（PH：16.4±13.2%，ETP：17.8±11.9%）。
ST Genesia 能够使用 STG-ThromboScreen 或 STG-DrugScreen 根据 xaban 浓度可靠地测量体外和体内 xaban 血浆样品中的 TG 参数。尽管不完全反映正常混合血浆的行为，但参考血浆的使用可能会提高标准化和实验室间比较的质量。
