Towards standardization of thrombin generation assays: Inventory of thrombin generation methods based on results of an International Society of Thrombosis and Haemostasis Scientific Standardization Committee survey
Towards standardization of thrombin generation assays: Inventory of thrombin generation methods based on results of an International Society of Thrombosis and Haemostasis Scientific Standardization Committee survey
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DOI：
10.1111/jth.14863
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发表时间：
2020-06-03
影响因子：
10.4
通讯作者：
de Laat, Bas
中科院分区：
文献类型：
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作者：
de Laat-Kremers, Romy M. W.;Ninivaggi, Marisa;de Laat, Bas
凝血酶生成（TG）是止血系统整体功能的一个更好的决定因素，而不是常规使用的基于凝血时间的测定。如今，TG广泛应用于止血研究团队，用于临床和基础研究。然而，在实验室之间关于预分析、试剂、TG协议、分析解释和normalization.Objectives的差异性很大，为了记录TG方法学的差异程度，我们的目标是收集调查中用于测量TG的所有方法。方法我们通过狼疮抗凝剂标准化委员会组织了一份调查问卷/国际血栓形成和止血学会科学标准化委员会的抗磷脂抗体。该问卷包括51个问题，关于TG的不同方面：类型的用户，方法，样本类型，分析和解释的结果，规范化，和质量controls.Results的240调查开始，108完成（45%）。然而，并非所有问题都在所有实验室的范围内。其中一半是研究实验室，一半是诊断实验室。最常用的TG测定法是校准的自动化基于凝血酶测定法（56%）。TG测定的几个方面存在分歧：采血针的类型、采血管、离心、样品储存和解冻、试剂、样品稀释、校准、参考范围、数据归一化等。一个标准化的协议和数据标准化应导致更好的再现性和比较来自不同实验室的数据。
Background Thrombin generation (TG) is a better determinant of the overall function of the hemostatic system than the routinely used clotting time-based assays. Nowadays, TG is widely used in hemostasis research teams, for both clinical and basic research. However, there is significant variability between laboratories regarding preanalytics, reagents, TG protocol, analysis interpretation, and normalization.Objectives To document the extent of variation in the methodology of TG, we aim to collect all the methods that are being used to measure TG in a survey.Methods We organized a questionnaire through the Standardization committee for Lupus Anticoagulant/Antiphospholipid Antibodies of the International Society of Thrombosis and Haemostasis Scientific Standardization committee. The questionnaire consisted of 51 questions regarding the different aspects of TG: type of users, methods, sample type, analysis, and interpretation of results, normalization, and quality control.Results Of the 240 surveys that were started, 108 were completed (45%). However, not all questions were in scope for all laboratories. One-half of the laboratories were research laboratories and half diagnostic laboratories. The most used TG assay was the calibrated automated thrombinography-based assay (56%). There was a divergence regarding several aspects of the TG assay: type of needle for blood collection, blood tubes, centrifugation, sample storage and thawing, reagents, sample dilution, calibration, reference ranges, data normalization, and so on.Conclusions There is an important variation in the methods used for measuring TG. A standardized protocol and data normalization should lead to a better reproducibility and for comparing data from different laboratories.