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
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Abstract	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.
AbstractList	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. 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. 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.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.
Author	Gouin-Thibault, Isabelle Guillermo, Cecilia Kitchen, Steve Bates, Shannon M. Douxfils, Jonathan Favaloro, Emmanuel J. Adcock, Dorothy M. Kawai, Yohko Gosselin, Robert C. Lindhoff-Last, Edelgard
Author_xml	– sequence: 1 givenname: Robert C. surname: Gosselin fullname: Gosselin, Robert C. – sequence: 2 givenname: Dorothy M. surname: Adcock fullname: Adcock, Dorothy M. email: adcockd@labcorp.com organization: Laboratory Corporation of America Holdings – sequence: 3 givenname: Shannon M. surname: Bates fullname: Bates, Shannon M. – sequence: 4 givenname: Jonathan surname: Douxfils fullname: Douxfils, Jonathan – sequence: 5 givenname: Emmanuel J. surname: Favaloro fullname: Favaloro, Emmanuel J. – sequence: 6 givenname: Isabelle surname: Gouin-Thibault fullname: Gouin-Thibault, Isabelle – sequence: 7 givenname: Cecilia surname: Guillermo fullname: Guillermo, Cecilia – sequence: 8 givenname: Yohko surname: Kawai fullname: Kawai, Yohko – sequence: 9 givenname: Edelgard surname: Lindhoff-Last fullname: Lindhoff-Last, Edelgard – sequence: 10 givenname: Steve surname: Kitchen fullname: Kitchen, Steve
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/29433148$$D View this record in MEDLINE/PubMed
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SubjectTerms	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
Title	International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants
URI	http://dx.doi.org/10.1055/s-0038-1627480 https://www.ncbi.nlm.nih.gov/pubmed/29433148 https://www.proquest.com/docview/2001914133
Volume	118
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