Department of Angiology and Blood Coagulation, S. Orsola-Malpighi University Hospital, Bologna, Italy.
Haemostasis and Thrombosis Center, Department of Laboratory Medicine, AO Istituti Ospitalieri, Cremona, Italy.
Int J Lab Hematol. 2018 Apr;40(2):229-236. doi: 10.1111/ijlh.12772. Epub 2018 Jan 3.
Several specific assays are commercially available to determine dabigatran anticoagulant activity. Aims of this multicenter and multiplatform study were to compare five methods for dabigatran measurement and investigate their performances in the low concentration range.
Dabigatran levels were analyzed in 295 plasma samples from patients enrolled in the START-Laboratory Register by the following methods using dedicated calibrators and controls: STA-ECA II (Diagnostica Stago), standard and low range Hemoclot Thrombin Inhibitors (Hyphen BioMed), Direct Thrombin Inhibitor Assay (Instrumentation Laboratory), Direct Thrombin Inhibitor Assay (Siemens), Technoclot DTI (Technoclone).
Methods showed variable agreement with the Hemoclot Thrombin Inhibitors assay used as reference test, with modest under- or overestimations (Bland-Altman bias from -17.3 to 4.0 ng/mL). Limits of detection and quantification varied depending on the assay (4-52 and 7-82 ng/mL, respectively). Between-run precision and accuracy were good for all methods for both quality control levels. Assay's repeatability assessed at very low dabigatran concentrations (from 10 to 60 ng/mL) was also acceptable, variability generally increased at lower drug levels.
The five dabigatran-specific assays evaluated in this study provided reliable assessment of dabigatran plasma levels, although showing different performances.
有几种特定的检测方法可用于确定达比加群的抗凝活性。本多中心、多平台研究的目的是比较五种达比加群测量方法，并研究它们在低浓度范围内的性能。
通过使用专用校准品和对照品，在来自参加 START-Laboratory 登记研究的 295 名患者的血浆样本中分析达比加群水平：STA-ECA II（Diagnostica Stago）、标准和低范围的 Hemoclot 凝血酶抑制剂（Hyphen BioMed）、直接凝血酶抑制剂测定法（Instrumentation Laboratory）、直接凝血酶抑制剂测定法（Siemens）、Technoclot DTI（Technoclone）。
方法与作为参考检测的 Hemoclot 凝血酶抑制剂检测法显示出不同的一致性，存在适度的低估或高估（Bland-Altman 偏倚范围从-17.3 至 4.0ng/mL）。检测限和定量限因检测方法而异（分别为 4-52 和 7-82ng/mL）。对于所有方法，两种质控水平的批内精密度和准确度均良好。在非常低的达比加群浓度（10-60ng/mL）下评估的测定法的重复性也可接受，通常在药物浓度较低时，变异性增加。
本研究评估的五种达比加群特异性检测方法可可靠地评估达比加群的血浆水平，尽管表现出不同的性能。
