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Thromb Haemost 2015; 113(01): 154-164
DOI: 10.1160/TH14-02-0161
New Technologies, Diagnostic Tools and Drugs
Schattauer GmbH

Influence of dabigatran and rivaroxaban on routine coagulation assays

A nationwide Belgian survey
Marjan Van Blerk
1   Department of Quality of Medical Laboratories, Scientific Institute of Public Health, Brussels, Belgium
,
Els Bailleul
2   EQA Advisory Board, Belgium
,
Bernard Chatelain
2   EQA Advisory Board, Belgium
,
Anne Demulder
2   EQA Advisory Board, Belgium
,
Katrien Devreese
2   EQA Advisory Board, Belgium
,
Jonathan Douxfils
2   EQA Advisory Board, Belgium
,
Kristin Jochmans
2   EQA Advisory Board, Belgium
,
François Mullier
2   EQA Advisory Board, Belgium
,
Walter Wijns
2   EQA Advisory Board, Belgium
,
Mohamed Rida Soumali
1   Department of Quality of Medical Laboratories, Scientific Institute of Public Health, Brussels, Belgium
,
Wim Coucke
1   Department of Quality of Medical Laboratories, Scientific Institute of Public Health, Brussels, Belgium
,
Kris Vernelen
1   Department of Quality of Medical Laboratories, Scientific Institute of Public Health, Brussels, Belgium
,
Philippe Van de Walle
1   Department of Quality of Medical Laboratories, Scientific Institute of Public Health, Brussels, Belgium
› Author Affiliations
Further Information

Publication History

Received: 20 February 2014

Accepted after major revision: 02 August 2014

Publication Date:
27 November 2017 (online)

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Summary

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.

Keywords

Dabigatran - external quality assessment - rivaroxaban - routine coagulation assays
 

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