INTRODUCTION: The Belgian national External Quality Assessment Scheme performed a survey to assess the effect of the direct oral anticoagulant apixaban on the coagulation assays prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen and antithrombin as performed with a large number of reagent/instrument combinations.
METHODS: Four lyophilized plasma samples spiked with apixaban (0, 41, 94 and 225 ng/mL) were sent to the 195 Belgian and Luxembourg clinical laboratories performing coagulation testing.
RESULTS: PT and aPTT were barely influenced at the concentrations tested. At 225 ng/mL apixaban, PT and aPTT clotting times were only 1.15 times longer than at 0 ng/mL. Among PT reagents, RecombiPlasTin 2G(®) showed a slightly higher sensitivity with 225 ng/mL apixaban prolonging the PT clotting time 1.3-fold. Among aPTT reagents, there was no appreciable difference in sensitivity. Fibrinogen results were unaffected by the presence of apixaban, but antithrombin activity was considerably overestimated when measured with a FXa-based assay. At 225 ng/mL apixaban, the median percentage increase in antithrombin level was 31% when measured with the Liquid Antithrombin(®) reagent and 44% with the Innovance Antithrombin(®) reagent.
CONCLUSION: Our data provide clinical laboratories with useful information on the impact of apixaban on their routine coagulation assays.
- direct oral anticoagulants
- external quality assessment
- routine coagulation assays
- Prothrombin Time
- Blood Coagulation Tests/methods
- Quality Assurance, Health Care
- Blood Coagulation/drug effects
- Factor Xa Inhibitors/pharmacology
- Partial Thromboplastin Time
- Drug Monitoring