Oude Elferink Rob F M, Loot Annemarieke E, Van De Klashorst Chantal G J, Hulsebos-Huygen Marieke, Piersma-Wichers Margriet, Oudega Ruud
Certe - Department of Clinical Chemistry , Groningen.
Scand J Clin Lab Invest. 2015 May;75(3):230-8. doi: 10.3109/00365513.2014.993697. Epub 2015 Jan 22.
D-dimer tests are an essential element in the diagnostic work-up of deep venous thrombosis (DVT). However, the poor standardization amongst assays necessitates clinical validation before implementation in daily practice. We therefore evaluated the analytical and diagnostic performance of eight D-dimer tests in a representative group of 290 prospectively identified consecutive primary care patients with suspected DVT. Seven quantitative D-dimer assays, and a qualitative test, Simplify, were evaluated. Correlation between assays was generally poor and several assays showed a significant bias in the method comparison. Nevertheless, the Vidas D-dimer, Innovance D-dimer (CA1500 and BCS), Pathfast D-dimer, and HemosIL HS500 (ACL TOP), all displayed 100% (95% CI: 85-100%) sensitivity. Tina-quant (Modular), AQT90 D-dimer, and Liatest (STA(®)) D-dimer tests showed a slightly lower sensitivity of 95% (78-100%). and the Simplify test reached a sensitivity of 91% (72-99%) that was further improved in combination with a clinical decision rule to 95% (76-100%). In concert with the low (8.2%) prevalence of proximal DVT, diagnosed by compression ultrasonography, in our study, all test reached a negative predictive value (NPV) of at least 99%. The user friendliness of the assays differed mainly by stability of reagents, calibration frequency, time required to obtain a test result and costs of a test. In conclusion, despite considerable analytical differences, in our low-risk population all tests evaluated displayed an excellent NPV. In combination with a validated clinical decision rule to identify low-risk patients, even a straightforward POC solution could safely and cost-efficiently rule out DVT.
D - 二聚体检测是深静脉血栓形成（DVT）诊断检查的重要组成部分。然而，各检测方法之间缺乏标准化，在日常实践中实施前需要进行临床验证。因此，我们在290例前瞻性确定的连续初级保健疑似DVT患者的代表性队列中，评估了8种D - 二聚体检测方法的分析性能和诊断性能。评估了7种定量D - 二聚体检测方法和1种定性检测方法Simplify。各检测方法之间的相关性普遍较差，在方法比较中几种检测方法存在显著偏差。尽管如此，Vidas D - 二聚体、Innovance D - 二聚体（CA1500和BCS）、Pathfast D - 二聚体和HemosIL HS500（ACL TOP）的灵敏度均为100%（95%CI：85 - 100%）。Tina - quant（Modular）、AQT90 D - 二聚体和Liatest（STA(®)）D - 二聚体检测方法的灵敏度略低，为95%（78 - 100%）。Simplify检测方法的灵敏度为91%（72 - 99%），与临床决策规则联合使用时进一步提高到95%（76 - 100%）。与本研究中通过压迫超声诊断的近端DVT的低患病率（8.2%）相一致，所有检测方法的阴性预测值（NPV）均至少达到99%。各检测方法的用户友好性主要在试剂稳定性、校准频率、获得检测结果所需时间和检测成本方面存在差异。总之，尽管存在显著的分析差异，但在我们的低风险人群中，所有评估的检测方法均显示出优异的NPV。结合经过验证的临床决策规则以识别低风险患者，即使是简单的即时检验解决方案也能安全且经济高效地排除DVT。
