دورية أكاديمية
Determination of dabigatran, rivaroxaban and apixaban by ultra-performance liquid chromatography - tandem mass spectrometry (UPLC-MS/MS) and coagulation assays for therapy monitoring of novel direct oral anticoagulants.
| العنوان: | Determination of dabigatran, rivaroxaban and apixaban by ultra-performance liquid chromatography - tandem mass spectrometry (UPLC-MS/MS) and coagulation assays for therapy monitoring of novel direct oral anticoagulants. |
|---|---|
| المؤلفون: | Schmitz EM; Clinical Laboratory, Catharina Hospital, Eindhoven, The Netherlands; Laboratory of Chemical Biology and Institute of Complex Molecular Systems, Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands; Expert Center Clinical Chemistry Eindhoven, Eindhoven, The Netherlands., Boonen K, van den Heuvel DJ, van Dongen JL, Schellings MW, Emmen JM, van der Graaf F, Brunsveld L, van de Kerkhof D |
| المصدر: | Journal of thrombosis and haemostasis : JTH [J Thromb Haemost] 2014 Oct; Vol. 12 (10), pp. 1636-46. |
| نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: England NLM ID: 101170508 Publication Model: Print Cited Medium: Internet ISSN: 1538-7836 (Electronic) Linking ISSN: 15387836 NLM ISO Abbreviation: J Thromb Haemost Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2023- : [New York] : Elsevier Original Publication: Oxford : Blackwell Pub. |
| مواضيع طبية MeSH: | Blood Coagulation Tests* , Chromatography, High Pressure Liquid* , Tandem Mass Spectrometry*, Anticoagulants/*administration & dosage , Benzimidazoles/*administration & dosage , Morpholines/*administration & dosage , Pyrazoles/*administration & dosage , Pyridones/*administration & dosage , Thiophenes/*administration & dosage , beta-Alanine/*analogs & derivatives, Administration, Oral ; Blood Coagulation/drug effects ; Calibration ; Dabigatran ; Factor Xa Inhibitors/chemistry ; Humans ; Quality Control ; Reference Values ; Reproducibility of Results ; Rivaroxaban ; beta-Alanine/administration & dosage |
| مستخلص: | Background: Three novel direct oral anticoagulants (DOACs) have recently been registered by the Food and Drug Administration and European Medicines Agency Commission: dabigatran, rivaroxaban, and apixaban. To quantify DOACs in plasma, various dedicated coagulation assays have been developed. Objective: To develop and validate a reference ultra-performance liquid chromatography - tandem mass spectrometry (UPLC-MS/MS) method and to evaluate the analytical performance of several coagulation assays for quantification of dabigatran, rivaroxaban, and apixaban. Methods: The developed UPLC-MS/MS method was validated by determination of precision, accuracy, specificity, matrix effects, lower limits of detection, carry-over, recovery, stability, and robustness. The following coagulation assays were evaluated for accuracy and precision: laboratory-developed (LD) diluted thrombin time (dTT), Hemoclot dTT, Pefakit PiCT, ECA, Liquid anti-Xa, Biophen Heparin (LRT), and Biophen DiXal anti-Xa. Agreement between the various coagulation assays and UPLC-MS/MS was determined with random samples from patients using dabigatran or rivaroxaban. Results: The UPLC-MS/MS method was shown to be accurate, precise, sensitive, stable, and robust. The dabigatran coagulation assay showing the best precision, accuracy and agreement with the UPLC-MS/MS method was the LD dTT test. For rivaroxaban, the anti-factor Xa assays were superior to the PiCT-Xa assay with regard to precision, accuracy, and agreement with the reference method. For apixaban, the Liquid anti-Xa assay was superior to the PiCT-Xa assay. Conclusions: Statistically significant differences were observed between the various coagulation assays as compared with the UPLC-MS/MS reference method. It is currently unknown whether these differences are clinically relevant. When DOACs are quantified with coagulation assays, comparison with a reference method as part of proficiency testing is therefore pivotal. (© 2014 International Society on Thrombosis and Haemostasis.) |
| فهرسة مساهمة: | Keywords: apixaban; dabigatran; drug monitoring; mass spectrometry; rivaroxaban |
| المشرفين على المادة: | 0 (Anticoagulants) 0 (Benzimidazoles) 0 (Factor Xa Inhibitors) 0 (Morpholines) 0 (Pyrazoles) 0 (Pyridones) 0 (Thiophenes) 11P2JDE17B (beta-Alanine) 3Z9Y7UWC1J (apixaban) 9NDF7JZ4M3 (Rivaroxaban) I0VM4M70GC (Dabigatran) |
| تواريخ الأحداث: | Date Created: 20140822 Date Completed: 20150707 Latest Revision: 20230829 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1111/jth.12702 |
| PMID: | 25142183 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1538-7836 |
|---|---|
| DOI: | 10.1111/jth.12702 |