Abstract
A new generation of antithrombotic agents, which are conventionally known as direct oral anticoagulants (DOACs), have recently emerged and are continuing to be developed. These provide direct inhibition of either thrombin (factor IIa; FIIa) or activated factor X (FXa) and currently include dabigatran (FIIa inhibitor) and rivaroxaban, apixaban, and edoxaban (FXa inhibitors). The dogma that DOACs do not require laboratory monitoring is countered by ongoing recognition that laboratory testing for drug effects is needed in many situations. In this review, we summarize the background to establishment of DOACs, assess which tests were found to be useful to screen for or quantitate drug effects/levels, and then review published guidelines/recommendations to assess concordance. In brief, (a) for the anti-FIIa agent dabigatran, the recommended screening assays are activated partial thromboplastin time (APTT) and/or thrombin time (TT), and the quantitative assays (using a dabigatran standard) are dilute TT/direct thrombin inhibitor assay (Hemoclot thrombin inhibitor) or an ecarin-based assay such as the ecarin clot time (ECT); (b) for the anti-FXa agent rivaroxaban, the recommended screening assay is the prothrombin time (PT), but this was not endorsed by all guidelines, and the quantitative assay (using a specific rivaroxaban standard) is an anti-FXa assay; (c) for the anti-FXa agent apixaban, the general insensitivity of PT and APTT prevented most groups from providing recommendation, and instead there was generalized support for direct quantitative assessment using anti-FXa assays and specific apixaban standard; (d) there is insufficient data for other direct anti-FXa agents and limited guidance in the literature.
References
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©2015 by De Gruyter
Artikel in diesem Heft
- Frontmatter
- Editorials
- The new and the old of heparin-induced thrombocytopenia
- Biological variation – reliable data is essential
- Biological variation: back to basics
- Review
- Influence of educational, audit and feedback, system based, and incentive and penalty interventions to reduce laboratory test utilization: a systematic review
- Opinion Papers
- Recent guidelines and recommendations for laboratory assessment of the direct oral anticoagulants (DOACs): is there consensus?
- Meeting report: present state of molecular genetics in clinical laboratories. Report on the VII European Symposium on Clinical Laboratory and In Vitro Diagnostic Industry in Barcelona
- Genetics and Molecular Diagnostics
- Non-invasive prenatal diagnosis of monogenic disorders: an optimized protocol using MEMO qPCR with miniSTR as internal control
- A novel biosensor-based microarray assay for the visualized detection of CYP2C19 ∗2, ∗3, ∗4 and ∗5 polymorphisms
- General Clinical Chemistry and Laboratory Medicine
- Preanalytical errors: a preliminary approach to the point of view of primary health care givers
- Comparison of Improvacuter™ tubes with BD Vacutainer™ tubes for various hormones in the aspects of stability and influence of gel separators
- Use of quality indicators to compare point-of-care testing errors in a neonatal unit and errors in a STAT central laboratory
- Serological features of antibodies to protamine inducing thrombocytopenia and thrombosis
- Comparison of three different immunoassays in the diagnosis of heparin-induced thrombocytopenia
- How the direct oral anticoagulant apixaban affects hemostatic parameters. Results of a multicenter multiplatform study
- Auto-validation of complete blood counts in an outpatient’s regional laboratory
- Performance evaluation of the digital cell imaging analyzer DI-60 integrated into the fully automated Sysmex XN hematology analyzer system
- Circulating keratan sulfate as a marker of metabolic changes of cartilage proteoglycan in juvenile idiopathic arthritis; influence of growth factors as well as proteolytic and prooxidative agents on aggrecan alterations
- Reference Values and Biological Variations
- Biological variation database: structure and criteria used for generation and update
- Cardiovascular Diseases
- The tumor necrosis factor-α –238G/A and IL-6 –572G/C gene polymorphisms and the risk of idiopathic dilated cardiomyopathy: a meta-analysis of 25 studies including 9493 cases and 13,971 controls
- Diabetes
- Multicentre evaluation of the Premier Hb9210 HbA1c analyser
- Infectious Diseases
- Determination of quality control limits for serological infectious disease testing using historical data
- Corrigendum
- Enrichment and enumeration of circulating tumor cells by efficient depletion of leukocyte fractions
- Letters to the Editors
- Influence of age and gender on red blood cell distribution width
- Effect of exhaustive running exercise on red blood cell distribution width
- Clinically useful samples and reference change value
- Loss of retinol stability in patient samples
- Evaluation of a new thyroglobulin sensitive assay in patients with differentiated thyroid cancer
- Caution in a case of highly discrepant carbohydrate antigen 19-9 values in an apparently healthy patient taking spirulina: a case report
- Influence of vitamin K antagonist treatment on activated partial thromboplastin time
- Evaluation of the diagnostic characteristics of urinary kidney injury molecule 1 (uKIM-1) and uKIM-1/creatinine ratio in the assessment of incipient diabetic kidney disease
Artikel in diesem Heft
- Frontmatter
- Editorials
- The new and the old of heparin-induced thrombocytopenia
- Biological variation – reliable data is essential
- Biological variation: back to basics
- Review
- Influence of educational, audit and feedback, system based, and incentive and penalty interventions to reduce laboratory test utilization: a systematic review
- Opinion Papers
- Recent guidelines and recommendations for laboratory assessment of the direct oral anticoagulants (DOACs): is there consensus?
- Meeting report: present state of molecular genetics in clinical laboratories. Report on the VII European Symposium on Clinical Laboratory and In Vitro Diagnostic Industry in Barcelona
- Genetics and Molecular Diagnostics
- Non-invasive prenatal diagnosis of monogenic disorders: an optimized protocol using MEMO qPCR with miniSTR as internal control
- A novel biosensor-based microarray assay for the visualized detection of CYP2C19 ∗2, ∗3, ∗4 and ∗5 polymorphisms
- General Clinical Chemistry and Laboratory Medicine
- Preanalytical errors: a preliminary approach to the point of view of primary health care givers
- Comparison of Improvacuter™ tubes with BD Vacutainer™ tubes for various hormones in the aspects of stability and influence of gel separators
- Use of quality indicators to compare point-of-care testing errors in a neonatal unit and errors in a STAT central laboratory
- Serological features of antibodies to protamine inducing thrombocytopenia and thrombosis
- Comparison of three different immunoassays in the diagnosis of heparin-induced thrombocytopenia
- How the direct oral anticoagulant apixaban affects hemostatic parameters. Results of a multicenter multiplatform study
- Auto-validation of complete blood counts in an outpatient’s regional laboratory
- Performance evaluation of the digital cell imaging analyzer DI-60 integrated into the fully automated Sysmex XN hematology analyzer system
- Circulating keratan sulfate as a marker of metabolic changes of cartilage proteoglycan in juvenile idiopathic arthritis; influence of growth factors as well as proteolytic and prooxidative agents on aggrecan alterations
- Reference Values and Biological Variations
- Biological variation database: structure and criteria used for generation and update
- Cardiovascular Diseases
- The tumor necrosis factor-α –238G/A and IL-6 –572G/C gene polymorphisms and the risk of idiopathic dilated cardiomyopathy: a meta-analysis of 25 studies including 9493 cases and 13,971 controls
- Diabetes
- Multicentre evaluation of the Premier Hb9210 HbA1c analyser
- Infectious Diseases
- Determination of quality control limits for serological infectious disease testing using historical data
- Corrigendum
- Enrichment and enumeration of circulating tumor cells by efficient depletion of leukocyte fractions
- Letters to the Editors
- Influence of age and gender on red blood cell distribution width
- Effect of exhaustive running exercise on red blood cell distribution width
- Clinically useful samples and reference change value
- Loss of retinol stability in patient samples
- Evaluation of a new thyroglobulin sensitive assay in patients with differentiated thyroid cancer
- Caution in a case of highly discrepant carbohydrate antigen 19-9 values in an apparently healthy patient taking spirulina: a case report
- Influence of vitamin K antagonist treatment on activated partial thromboplastin time
- Evaluation of the diagnostic characteristics of urinary kidney injury molecule 1 (uKIM-1) and uKIM-1/creatinine ratio in the assessment of incipient diabetic kidney disease