Hemophilia Treatment Center, University of California, Davis Health System, Sacramento, California, United States.
Colorado Coagulation, Englewood, Colorado, United States.
Thromb Haemost. 2018 Mar;118(3):437-450. doi: 10.1055/s-0038-1627480. Epub 2018 Feb 12.
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.
本指导文件由国际血液学标准化委员会（ICSH）编写，旨在为临床实验室提供与止血相关的指导文件。这是首份关于凝血的 ICSH 文件，由一个由国际临床和实验室直接作用口服抗凝剂（DOAC）专家组成的特别委员会制定。该委员会就 DOAC（达比加群、利伐沙班、阿哌沙班和依度沙班）的实验室检测制定了共识建议，这些建议对评估 DOAC 抗凝作用的实验室具有重要意义。本指导文件涵盖了实验室 DOAC 测量的所有阶段，包括分析前（例如首选时间采集样本、首选样本类型、样本稳定性）、分析中和分析后（例如报告单位、质量保证）。委员会还讨论了筛选试验（如凝血酶原时间、活化部分凝血活酶时间以及凝血血液的粘弹性测量和即时检测方法）的应用和局限性。此外，委员会还就实验室检测在临床应用前进行适当验证或确认性能以及外部质量保证提供了建议，以持续评估检测和报告方法。
