title: Influence of dabigatran and rivaroxaban on routine coagulation assays. A nationwide Belgian survey.
abstract: The Belgian national External Quality Assessment Scheme performed a nationwide survey using lyophilised plasma samples spiked with dabigatran or rivaroxaban to demonstrate to the Belgian clinical laboratories how these drugs affect their routine coagulation assays prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen and antithrombin. Virtually all Belgian laboratories performing routine coagulation testing (189/192) participated in the survey. Both, dabigatran and rivaroxaban significantly prolonged the PT and aPTT in a concentration- and reagent-dependent manner. PT reagents were more influenced by rivaroxaban than by dabigatran and aPTT reagents more influenced by dabigatran than by rivaroxaban. Among PT reagents, Neoplastin R® was the most sensitive to rivaroxaban and Innovin® and Thromborel S® the least sensitive. Converting PT results to INR only increased the variability between reagents. Among aPTT reagents, Actin FSL® was the least sensitive to dabigatran while the other aPTT reagents showed slightly higher sensitivities. The presence of dabigatran led to falsely reduced fibrinogen concentrations when measured with a low thrombin concentration reagent. The presence of dabigatran caused an overestimation of the antithrombin level when measured with a thrombin-based activity assay and the presence of rivaroxaban an overestimation of the antithrombin level when measured with a FXa-based assay. Instrument-related differences were found for all tested parameters. In conclusion, this paper provides detailed information on the effect of dabigatran and rivaroxaban on routine coagulation assays as performed with a large number of reagent/instrument combinations.
authors.affiliation: Marjan Van Blerk, Wetenschappelijk Instituut Volksgezondheid, Kwaliteit van medische laboratoria, J. Wytsmanstraat 14, 1050 Brussels, Belgium, Tel.: +32 2 642 53 83, Fax: +32 2 642 56 45, E-mail: mvanblerk@wiv-isp.be.
authors.forename: Marjan
authors.initials: M
authors.lastname: Van Blerk
authors.forename: Els
authors.initials: E
authors.lastname: Bailleul
authors.forename: Bernard
authors.initials: B
authors.lastname: Chatelain
authors.forename: Anne
authors.initials: A
authors.lastname: Demulder
authors.forename: Katrien
authors.initials: K
authors.lastname: Devreese
authors.forename: Jonathan
authors.initials: J
authors.lastname: Douxfils
authors.forename: Kristin
authors.initials: K
authors.lastname: Jochmans
authors.forename: François
authors.initials: F
authors.lastname: Mullier
authors.forename: Walter
authors.initials: W
authors.lastname: Wijns
authors.forename: Mohamed Rida
authors.initials: MR
authors.lastname: Soumali
authors.forename: Wim
authors.initials: W
authors.lastname: Coucke
authors.forename: Kris
authors.initials: K
authors.lastname: Vernelen
authors.forename: Philippe
authors.initials: P
authors.lastname: Van de Walle
mesh_terms: D000284:Administration, Oral; D000925:Anticoagulants / Q000008:administration & dosage*; D000991:Antithrombins / Q000378:metabolism; D001530:Belgium; D001562:Benzimidazoles / Q000008:administration & dosage*; D015415:Biomarkers / Q000097:blood; D001777:Blood Coagulation / Q000187:drug effects*; D000069604:Dabigatran; D004305:Dose-Response Relationship, Drug; D004867:Equipment Design; D005340:Fibrinogen / Q000378:metabolism; D019538:Health Care Surveys; D006801:Humans; D059021:Laboratory Proficiency Testing / Q000379:methods*; D009025:Morpholines / Q000008:administration & dosage*; D015588:Observer Variation; D010314:Partial Thromboplastin Time / Q000295:instrumentation / Q000592:standards*; D011237:Predictive Value of Tests; D011517:Prothrombin Time / Q000295:instrumentation / Q000592:standards*; D019984:Quality Indicators, Health Care / Q000592:standards; D015203:Reproducibility of Results; D000069552:Rivaroxaban; D013876:Thiophenes / Q000008:administration & dosage*; D013997:Time Factors; D015091:beta-Alanine / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D001562:Benzimidazoles; D015415:Biomarkers; D009025:Morpholines; D013876:Thiophenes; D015091:beta-Alanine; D005340:Fibrinogen; D000069552:Rivaroxaban; D000069604:Dabigatran
keywords: Dabigatran; external quality assessment; rivaroxaban; routine coagulation assays