Department of Clinical Chemistry, Amsterdam UMC, Amsterdam, the Netherlands.
Department of Clinical Chemistry, Amsterdam UMC, Amsterdam, the Netherlands.
Thromb Res. 2021 May;201:18-22. doi: 10.1016/j.thromres.2021.02.003. Epub 2021 Feb 6.
For exclusion of pulmonary embolism (PE) clinical decision rules in combination with a D-dimer assay are applied. Currently available D-dimer assays are not standardized and it is unknown whether these differences have an impact on diagnostic management of suspected PE. Therefore, the aim is to explore differences between D-dimer assays and their impact on diagnostic outcome.
Data from all patients included in the YEARS study were collected. The YEARS study is a prospective, multicentre, cohort outcome study evaluating 3462 patients with suspected PE in which four different D-dimer assays were applied (Liatest, Innovance, Tinaquant, Vidas). Median D-dimer concentrations were calculated for each D-dimer assay. Sensitivity, specificity, PPV and NPV for detection of PE of all four assays were determined in patients without YEARS items and in those with ≥1 YEARS items (i.e. symptomatic deep vein thrombosis, haemoptysis, and whether PE is the most likely diagnosis).
A total of 1323, 1100, 768 and 271 D-dimer concentrations were collected using the Liatest Innovance, Tinaquant and Vidas assay, respectively. Median D-dimer concentrations differed significantly between assays, with lowest values in the Tinaquant assay. In patients without YEARS items using a cutoff level of 1000 ng/mL, the NPV varied from 99,5 to 100%. In patients with ≥1 YEARS items using a 500 ng/mL cutoff, the NPV varied from 97,0 to 100% depending on the assay.
The overall high NPV for all assays demonstrates the clinical value of the D-dimer assay. However, these results confirm differences between D-dimer assays, which have an impact on follow-up imaging. This emphasizes the need for standardization of D-dimer assays.
为了排除肺栓塞（PE），临床决策规则与 D-二聚体检测联合应用。目前可用的 D-二聚体检测方法尚未标准化，尚不清楚这些差异是否会对疑似 PE 的诊断管理产生影响。因此，本研究旨在探讨 D-二聚体检测方法之间的差异及其对诊断结果的影响。
收集 YEARS 研究中所有纳入患者的数据。YEARS 研究是一项前瞻性、多中心、队列研究，共纳入 3462 例疑似 PE 患者，应用了四种不同的 D-二聚体检测方法（Liatest、Innovance、Tinaquant、Vidas）。计算了每种 D-二聚体检测方法的中位数 D-二聚体浓度。在无 YEARS 项目的患者和有≥1 项 YEARS 项目的患者（即有症状性深静脉血栓形成、咯血，以及 PE 是否最有可能诊断）中，确定了所有四种检测方法检测 PE 的敏感性、特异性、阳性预测值和阴性预测值。
分别使用 Liatest、Innovance、Tinaquant 和 Vidas 检测方法，共收集了 1323、1100、768 和 271 个 D-二聚体浓度。检测方法之间的 D-二聚体浓度中位数差异有统计学意义，Tinaquant 检测方法的 D-二聚体浓度最低。在无 YEARS 项目的患者中，使用 1000ng/mL 截断值时，NPV 为 99.5%至 100%。在有≥1 项 YEARS 项目的患者中，使用 500ng/mL 截断值时，NPV 因检测方法而异，为 97.0%至 100%。
所有检测方法的总体高 NPV 均表明 D-二聚体检测具有临床价值。然而，这些结果证实了 D-二聚体检测方法之间的差异，这些差异会影响后续的影像学检查。这强调了需要对 D-二聚体检测方法进行标准化。
