Djurabi R Karami, Klok F A, Nijkeuter M, Kaasjager K, Kamphuisen P W, Kramer M H H, Kruip M J H A, Leebeek F W G, Büller Harry R, Huisman M V
Section of Vascular Medicine, Department of General Internal Medicine - Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.
Thromb Res. 2009 Mar;123(5):771-4. doi: 10.1016/j.thromres.2008.07.014. Epub 2008 Sep 24.
Quantitative D-Dimer tests are established methods in the non-invasive diagnostic management to rule out venous thromboembolism (VTE). The diagnostic performance and the clinical efficiency different D-Dimer assays in the exclusion of pulmonary embolism (PE) have not yet been compared in a clinical outcome study.
Evaluation of the efficiency and safety of excluding the diagnosis of PE with two different quantitative D-Dimer assays in consecutive patients with clinically suspected PE.
We studied the VTE-failure rate of 2206 consecutive patients with an unlikely clinical probability in whom VIDAS or Tinaquant D-Dimer tests were performed.
The prevalence of PE in 1238 patients whose D-Dimer level was analyzed with Tinaquant assay was 11%. The VIDAS assay group consisted of 968 patients with a PE prevalence of 13%. The VIDAS assay had a sensitivity of 99.2% (95%CI; 96- >99.9%), the Tinaquant assay of 97.3% (95%CI; 93 -99%). The negative predictive value (NPV) in the Tinaquant assay group was 99.4% (95%CI 98-99.8%) in comparison to 99.7% (95%CI 99->99.9%) in the VIDAS assay group. During 3 month of follow-up, there were no fatal cases of PE among patients with normal D-Dimer and unlikely clinical probability in both D-Dimer assay groups. In addition, the test efficiency of Tinaquant assay was significantly higher in comparison to VIDAS assay (52% vs 42%, p<0.001).
Both Tinaquant and VIDAS D-Dimer tests perform equally well in combination with an unlikely clinical probability in excluding PE. The Tinaquant test was shown to be more efficient.
定量D - 二聚体检测是排除静脉血栓栓塞症（VTE）的非侵入性诊断管理中的既定方法。在一项临床结局研究中，尚未对不同D - 二聚体检测方法在排除肺栓塞（PE）方面的诊断性能和临床效率进行比较。
评估在连续的临床疑似PE患者中，两种不同的定量D - 二聚体检测方法排除PE诊断的效率和安全性。
我们研究了2206例临床可能性不大且进行了VIDAS或Tinaquant D - 二聚体检测的连续患者的VTE失败率。
用Tinaquant检测法分析D - 二聚体水平的1238例患者中PE的患病率为11%。VIDAS检测组由968例患者组成，PE患病率为13%。VIDAS检测的灵敏度为99.2%（95%CI；96 - >99.9%），Tinaquant检测为97.3%（95%CI；93 - 99%）。Tinaquant检测组的阴性预测值（NPV）为99.4%（95%CI 98 - 99.8%），而VIDAS检测组为99.7%（95%CI 99 - >99.9%）。在3个月的随访期间，两个D - 二聚体检测组中D - 二聚体正常且临床可能性不大的患者中均无PE死亡病例。此外，Tinaquant检测的检测效率明显高于VIDAS检测（52%对42%，p<0.001）。
Tinaquant和VIDAS D - 二聚体检测在结合临床可能性不大的情况下排除PE方面表现同样良好。Tinaquant检测显示效率更高。
