Janssen M C, Wollersheim H, Verbruggen B, Nováková I R
Department of General Internal Medicine, University Hospital Nijmegen, The Netherlands.
Semin Thromb Hemost. 1998;24(4):393-400. doi: 10.1055/s-2007-996028.
Studies measuring the fibrin degradation product D-Dimer (DD) using enzyme-linked immunosorbent assays (ELISA) in patients suspected of deep venous thrombosis (DVT) or pulmonary embolism (PE) suggest that it is possible to exclude DVT/PE when the DD level is below a certain cut-off value. However, ELISA methods are time-consuming, bare high costs, and are only available in experienced laboratories. For this reason several rapid and less costly DD assays have been recently developed. This article reviews the current literature about rapid latex and ELISA DD assays in the diagnostic approach of DVT and PE. Two new latex assays seem suitable in clinical practice. The most extensively studied assay is the so-called SimpliRed DD, an autologous red cell agglutination test that can be performed on fresh whole blood. For DVT a sensitivity (Sens) and a negative predictive value (NPV) of 89-100% and 95-100%, respectively, have been reported, for PE 94-100% and 98-100%, respectively. The second test, Tinaquant, is a quantitative latex assay. Sens and NPV for DVT of 99% and 93% have been reported in one study. Two rapid ELISA assays have been investigated. The most extensively studied is the VIDAS DD assay, a fully automated quantitative ELISA method. Sens and NPV of 94-100% and 92-100% for DVT and both 100% for PE have been reported. For the other rapid ELISA, Instant IA DD, Sens and NPV of 92-93% and 76-77% have been reported for DVT. The last one is a qualitative assay giving only positive or negative results. These results show that low concentrations of plasma DD measured by especially SimpliRed or VIDAS DD, might be used to reliably rule out DVT or PE in clinically suspected patients. Tinaquant seems promising and has to be evaluated further. As for standard ELISA, increased DD concentrations are of no use because of the low specificity of the assays. Future studies should assess the clinical usefulness of both assays in management trials under routine conditions, in the frame of clinical decision-making diagnostic processes to prove that withholding further noninvasive testing and/or anticoagulants in patients with a low or negative DD is safe. Strategies to identify patients with false-negative results should be developed.
在疑似深静脉血栓形成（DVT）或肺栓塞（PE）的患者中，使用酶联免疫吸附测定（ELISA）检测纤维蛋白降解产物D - 二聚体（DD）的研究表明，当DD水平低于某个临界值时，有可能排除DVT/PE。然而，ELISA方法耗时、成本高，且仅在有经验的实验室可用。因此，最近开发了几种快速且成本较低的DD检测方法。本文综述了当前关于快速乳胶法和ELISA法检测DD在DVT和PE诊断方法中的文献。两种新的乳胶检测方法似乎适用于临床实践。研究最广泛的检测方法是所谓的SimpliRed DD，一种可在新鲜全血上进行的自身红细胞凝集试验。对于DVT，报告的灵敏度（Sens）和阴性预测值（NPV）分别为89 - 100%和95 - 100%，对于PE分别为94 - 100%和98 - 100%。第二项检测方法Tinaquant是一种定量乳胶检测法。在一项研究中，报告DVT的Sens和NPV分别为99%和93%。研究了两种快速ELISA检测方法。研究最广泛的是VIDAS DD检测法，一种全自动定量ELISA方法。报告DVT的Sens和NPV分别为94 - 100%和92 - 100%，PE的两者均为100%。对于另一种快速ELISA方法Instant IA DD，报告DVT的Sens和NPV分别为92 - 93%和76 - 77%。最后一种是定性检测，仅给出阳性或阴性结果。这些结果表明，特别是通过SimpliRed或VIDAS DD检测到的低浓度血浆DD，可用于可靠地排除临床疑似患者的DVT或PE。Tinaquant似乎很有前景，有待进一步评估。至于标准ELISA，由于检测方法的低特异性，DD浓度升高并无用处。未来的研究应在常规条件下的管理试验中评估这两种检测方法在临床决策诊断过程中的临床实用性，以证明在DD值低或为阴性的患者中不进行进一步的无创检测和/或抗凝治疗是安全的。应制定识别假阴性结果患者的策略。
