Elias A, Aptel I, Huc B, Chalé J J, Nguyen F, Cambus J P, Boccalon H, Boneu B
Service d'Angiologie, Hôpital de Rangueil, Toulouse, France.
Thromb Haemost. 1996 Oct;76(4):518-22.
The current D-Dimer ELISA methods provide high sensitivity and negative predictive value for the diagnosis of deep vein thrombosis but these methods are not suitable for emergency or for individual determination. We have evaluated the performance of 3 newly available fast D-Dimer assays (Vidas D-Di, BioMérieux; Instant IA D-Di, Stago; Nycocard D-Dimer, Nycomed) in comparison with 3 classic ELISA methods (Stago, Organon, Behring) and a Latex agglutination technique (Stago). One-hundred-and-seventy-one patients suspected of presenting a first episode of deep vein thrombosis were investigated. A deep vein thrombosis was detected in 75 patients (43.8%) by ultrasonic duplex scanning of the lower limbs; in 11 of them the thrombi were distal and very limited in size (< 2 cm). We compared the performance of the tests by calculating their sensitivity, specificity, positive and negative predictive value for different cut-off levels and by calculating the area under ROC curves. The concordance of the different methods was evaluated by calculating the kappa coefficient. The performances of the 3 classic ELISA and of the Vidas D-Di were comparable and kappa coefficients indicated a good concordance between the results provided by these assays. Their sensitivity slightly declined for detection of the very small thrombi. Instant IA D-Di had a non-significantly lower sensitivity and negative predictive value than the 4 previous assays; however its performance was excellent for out-patients. As expected, the Latex assay had too low a sensitivity and negative predictive value to be recommended. In our hands, Nycocard D-Dimer also exhibited low sensitivity and negative predictive value, which were significantly improved when the plasma samples were tested by the manufacturer. Thus significant progress has been made, allowing clinical studies to be planned to compare the safety and cost-effectiveness of D-Dimer strategy to those of the conventional methods for the diagnosis of venous thrombosis.
目前的D - 二聚体ELISA方法在诊断深静脉血栓形成方面具有高灵敏度和阴性预测价值，但这些方法不适用于急诊或个体检测。我们评估了3种新的快速D - 二聚体检测方法（Vidas D - Di，生物梅里埃公司；Instant IA D - Di，思塔高公司；Nycocard D - 二聚体，奈科明公司）的性能，并与3种经典ELISA方法（思塔高公司、欧加农公司、贝林公司）以及一种乳胶凝集技术（思塔高公司）进行了比较。对171例疑似首次发生深静脉血栓形成的患者进行了研究。通过下肢超声双功扫描在75例患者（43.8%）中检测到深静脉血栓形成；其中11例患者的血栓位于远端且尺寸非常小（< 2 cm）。我们通过计算不同临界值水平下的灵敏度、特异性、阳性和阴性预测值以及计算ROC曲线下面积来比较这些检测方法的性能。通过计算kappa系数评估不同方法之间的一致性。3种经典ELISA方法和Vidas D - Di的性能相当，kappa系数表明这些检测方法提供的结果之间具有良好的一致性。它们对非常小的血栓的检测灵敏度略有下降。Instant IA D - Di与前4种检测方法相比，灵敏度和阴性预测值略低，但差异无统计学意义；然而，其性能对于门诊患者来说非常出色。正如预期的那样，乳胶检测方法的灵敏度和阴性预测值过低，不推荐使用。在我们的研究中，Nycocard D - 二聚体也表现出低灵敏度和阴性预测值，当由制造商对血浆样本进行检测时，这些值得到了显著改善。因此已经取得了显著进展，这使得可以计划进行临床研究，以比较D - 二聚体策略与传统静脉血栓诊断方法的安全性和成本效益。
