International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants

Abstract This guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH) for providing haemostasis-related guidance documents for clinical laboratories. This inaugural coagulation ICSH document was developed by an ad hoc committee, comprised of in...

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Published in:Thrombosis and haemostasis Vol. 118; no. 3; pp. 437 - 450
Main Authors: Gosselin, Robert C., Adcock, Dorothy M., Bates, Shannon M., Douxfils, Jonathan, Favaloro, Emmanuel J., Gouin-Thibault, Isabelle, Guillermo, Cecilia, Kawai, Yohko, Lindhoff-Last, Edelgard, Kitchen, Steve
Format: Journal Article
Language:English
Published: Stuttgart Schattauer GmbH 01.03.2018
Subjects:
Administration, Oral
Anticoagulants - analysis
Chromatography - standards
Clinical Laboratory Techniques - standards
Consensus Document
Dabigatran - analysis
Hematology - methods
Hematology - standards
Humans
International Cooperation
Mass Spectrometry - standards
Partial Thromboplastin Time
Point-of-Care Testing - standards
Prothrombin - analysis
Prothrombin Time
Pyrazoles - analysis
Pyridines - analysis
Pyridones - analysis
Quality Assurance, Health Care
Rivaroxaban - analysis
Thiazoles - analysis
direct oral anticoagulants
laboratory guidance
laboratory measurement
recommendations
ISSN:0340-6245, 2567-689X, 2567-689X
Online Access:Get full text
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Summary:Abstract This guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH) for providing haemostasis-related guidance documents for clinical laboratories. This inaugural coagulation ICSH document was developed by an ad hoc committee, comprised of international clinical and laboratory direct acting oral anticoagulant (DOAC) experts. The committee developed consensus recommendations for laboratory measurement of DOACs (dabigatran, rivaroxaban, apixaban and edoxaban), which would be germane for laboratories assessing DOAC anticoagulation. This guidance document addresses all phases of laboratory DOAC measurements, including pre-analytical (e.g. preferred time sample collection, preferred sample type, sample stability), analytical (gold standard method, screening and quantifying methods) and post analytical (e.g. reporting units, quality assurance). The committee addressed the use and limitations of screening tests such as prothrombin time, activated partial thromboplastin time as well as viscoelastic measurements of clotting blood and point of care methods. Additionally, the committee provided recommendations for the proper validation or verification of performance of laboratory assays prior to implementation for clinical use, and external quality assurance to provide continuous assessment of testing and reporting method.
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ISSN:0340-6245
2567-689X
2567-689X
DOI:10.1055/s-0038-1627480