Rivaroxaban: Quantification by anti-FXa assay and influence on coagulation tests: a study in 9 Swiss laboratories.

Détails

ID Serval
serval:BIB_45EF032BD7EE
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Rivaroxaban: Quantification by anti-FXa assay and influence on coagulation tests: a study in 9 Swiss laboratories.
Périodique
Thrombosis Research
Auteur(s)
Asmis L.M., Alberio L., Angelillo-Scherrer A., Korte W., Mendez A., Reber G., Seifert B., Stricker H., Tsakiris D.A., Wuillemin W.A.
ISSN
1879-2472 (Electronic)
ISSN-L
0049-3848
Statut éditorial
Publié
Date de publication
2012
Peer-reviewed
Oui
Volume
129
Numéro
4
Pages
492-498
Langue
anglais
Notes
Publication types: Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
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 10mg 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 - 3hours after ingestion of 10mg 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±43μg/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 10mg RXA results in significant alterations of both PT- and aPTT-based coagulation assays.
Mots-clé
Adult, Anticoagulants/blood, Artifacts, Blood Coagulation Tests/methods, Drug Monitoring/methods, Factor Xa/antagonists & inhibitors, Humans, Male, Morpholines/blood, Reproducibility of Results, Sensitivity and Specificity, Switzerland, Thiophenes/blood
Pubmed
Web of science
Création de la notice
16/02/2012 12:54
Dernière modification de la notice
03/03/2018 16:46
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