Rivaroxaban: Quantification by anti-FXa assay and influence on coagulation tests A study in 9 Swiss laboratories
Rivaroxaban: Quantification by anti-FXa assay and influence on coagulation tests A study in 9 Swiss laboratories
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DOI：
10.1016/j.thromres.2011.06.031
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发表时间：
2012-04-01
影响因子：
7.5
通讯作者：
Wuillemin, W. A.
中科院分区：
文献类型：
--
作者：
Asmis, L. M.;Alberio, L.;Wuillemin, W. A.
简介：利伐沙班（RXA）被许可用于预防下肢大型骨科手术后的静脉血栓栓塞。目前，尚未在实验室间环境中验证量化血浆中 RXA 的测试。我们的研究有三个目的：评估 i) 使用商业抗 FXa 测定进行 RXA 定量的可行性，ii) 在实验室间环境中的准确性和精密度，以及 iii) 10 mg RXA 对常规凝血测试的影响。 方法：所有参与实验室均使用相同的显色抗 FXa 测定 (Hyphen BioMed)。 RXA 校准器和盲探针组（目标 ii.）是通过掺入正常血浆在体外制备的。通过高压液相色谱-串联质谱法评估精确的RXA含量。对于离体研究（目标 iii），参与实验室对 20 名健康志愿者在摄入 10 毫克 RXA 之前和摄入 2 - 3 小时后采集的血浆样本进行了分析。结果：可以对 RXA 进行显色分析。在参与实验室中，RXA 定量精度的平均准确度和平均变异系数分别为 7.0% 和 8.8%。平均 RXA 浓度为 114 +/- 43 μg/L。 RXA 显着改变凝血酶原时间、活化部分凝血活酶时间、内在和外在因素的因素分析。凝血酶时间、纤维蛋白原、FXIII 和 D-二聚体水平的测定不受影响。结论：通过在不同实验室的不同凝血计上进行显色抗 FXa 测定，可以准确、精确地定量 RXA 血浆水平。摄入 10 mg RXA 会导致基于 PT 和 aPTT 的凝血测定发生显着改变。 (C) 2011 Elsevier Ltd. 保留所有权利。
Introduction: Rivaroxaban (RXA) is licensed for prophylaxis of venous thromboembolism after major orthopaedic surgery of the lower limbs. Currently, no test to quantify RXA in plasma has been validated in an inter-laboratory setting.Our study had three aims: to assess i) the feasibility of RXA quantification with a commercial anti-FXa assay, ii) its accuracy and precision in an inter-laboratory setting, and iii) the influence of 10 mg of RXA on routine coagulation tests.Methods: The same chromogenic anti-FXa assay (Hyphen BioMed) was used in all participating laboratories. RXA calibrators and sets of blinded probes (aim ii.) were prepared in vitro by spiking normal plasma. The precise RXA content was assessed by high-pressure liquid chromatography-tandem mass spectrometry. For ex-vivo studies (aim iii), plasma samples from 20 healthy volunteers taken before and 2 - 3 hours after ingestion of 10 mg of RXA were analyzed by participating laboratories.Results: RXA can be assayed chromogenically. Among the participating laboratories, the mean accuracy and the mean coefficient of variation for precision of RXA quantification were 7.0% and 8.8%, respectively. Mean RXA concentration was 114 +/- 43 mu g/L. RXA significantly altered prothrombin time, activated partial thromboplastin time, factor analysis for intrinsic and extrinsic factors. Determinations of thrombin time, fibrinogen, FXIII and D-Dimer levels were not affected.Conclusions: RXA plasma levels can be quantified accurately and precisely by a chromogenic anti-FXa assay on different coagulometers in different laboratories. Ingestion of 10 mg RXA results in significant alterations of both PT-and aPTT-based coagulation assays. (C) 2011 Elsevier Ltd. All rights reserved.