Accuracy and consistency of anti-Xa activity measurement for determination of rivaroxaban plasma levels.

Détails

ID Serval
serval:BIB_A9A3D4C4BE3B
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Accuracy and consistency of anti-Xa activity measurement for determination of rivaroxaban plasma levels.
Périodique
Journal of thrombosis and haemostasis
Auteur(s)
Studt J.D., Alberio L., Angelillo-Scherrer A., Asmis L.M., Fontana P., Korte W., Mendez A., Schmid P., Stricker H., Tsakiris D.A., Wuillemin W.A., Nagler M.
ISSN
1538-7836 (Electronic)
ISSN-L
1538-7836
Statut éditorial
Publié
Date de publication
08/2017
Peer-reviewed
Oui
Volume
15
Numéro
8
Pages
1576-1583
Langue
anglais
Notes
Publication types: Evaluation Studies ; Journal Article ; Multicenter Study
Publication Status: ppublish
Résumé
Essentials Accurate determination of anticoagulant plasma concentration is important in clinical practice. We studied the accuracy and consistency of anti-Xa assays for rivaroxaban in a multicentre study. In a range between 50 and 200 μg L <sup>-1</sup> , anti-Xa activity correlated well with plasma concentrations. The clinical value might be limited by overestimation and intra- and inter-individual variation.
Background Determining the plasma level of direct oral anticoagulants reliably is important in the work-up of complex clinical situations. Objectives To study the accuracy and consistency of anti-Xa assays for rivaroxaban plasma concentration in a prospective, multicenter evaluation study employing different reagents and analytical platforms. Methods Rivaroxaban 20 mg was administered once daily to 20 healthy volunteers and blood samples were taken at peak and trough levels (clinicaltrials.gov NCT01710267). Anti-Xa activity was determined in 10 major laboratories using different reagents and analyzers; corresponding rivaroxaban plasma concentrations were measured by high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS). Findings Overall Pearson's correlation coefficient of anti-Xa levels and HPLC-MS results was 0.99 for Biophen <sup>®</sup> Heparin (95% CI, 0.99, 0.99), Biophen <sup>®</sup> DiXaI (95% CI, 0.99, 0.99) and STA <sup>®</sup> anti-Xa liquid (95% CI, 0.99, 1.00). Correlation was lower in rivaroxaban concentrations below 50 μg L <sup>-1</sup> and above 200 μg L <sup>-1</sup> . The overall bias of the Bland-Altman difference plot was 14.7 μg L <sup>-1</sup> for Biophen Heparin, 17.9 μg L <sup>-1</sup> for Biophen DiXal and 19.0 μg L <sup>-1</sup> for STA anti-Xa liquid. Agreement between laboratories was high at peak level but limited at trough level. Conclusions Anti-Xa activity correlated well with rivaroxaban plasma concentrations, especially in a range between 50 and 200 μg L <sup>-1</sup> . However, anti-Xa assays systematically overestimated rivaroxaban concentration as compared with HPLC-MS, particularly at higher concentrations. This overestimation, coupled with an apparent interindividual variation, might affect the interpretation of results in some situations.

Mots-clé
Administration, Oral, Adolescent, Adult, Aged, Blood Coagulation/drug effects, Chromatography, High Pressure Liquid, Drug Monitoring/methods, Factor Xa/metabolism, Factor Xa Inhibitors/administration & dosage, Factor Xa Inhibitors/blood, Healthy Volunteers, Humans, Laboratory Proficiency Testing, Male, Middle Aged, Observer Variation, Predictive Value of Tests, Prospective Studies, Reproducibility of Results, Rivaroxaban/administration & dosage, Rivaroxaban/blood, Switzerland, Tandem Mass Spectrometry, Young Adult, blood coagulation tests, drug monitoring, factor Xa inhibitors, reproducibility of results, rivaroxaban, sensitivity and specificity
Pubmed
Web of science
Création de la notice
19/06/2017 9:15
Dernière modification de la notice
20/08/2019 16:13
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