Rochemaure J, Laaban J P, Achkar A, Fretault J, Samama M
Service de Pneumologie et Réanimation, Hôtel-Dieu de Paris.
Bull Acad Natl Med. 1995 Feb;179(2):299-314; discussion 314-6.
The aim of this study is to evaluate the usefulness of plasma measurements of D-dimer using ELISA method and latex agglutination test in the diagnostic approach of venous thromboembolism. Among 126 patients suspected of pulmonary embolism (80 pat.) or deep venous thrombosis of the legs (46 pat.), the diagnosis of acute venous thromboembolism has been confirmed using gold standard invasive techniques (pulmonary angiography and/or contrast venography) in 49% of them. The sensitivity, specificity, negative predictive value and positive predictive value of a D-dimer plasma concentration above 500 ng/ml, on admission day, for the diagnosis of venous thromboembolism are 98%, 66%, 97%, 74% respectively when using the ELISA method, and 87%, 70%, 85%, 74% respectively when using the latex assay. In the 51 patients with a lung scan showing an indeterminate probability of pulmonary embolism, the sensitivity of the ELISA method is very high (94%) but that of the latex assay is low (67%). The repetition of D-dimer measurement on days 2 and 4 following admission has no significant effect on the sensitivity of the ELISA and latex assays. Our results demonstrate that the measurement of plasma D-dimer concentration using latex assay should not be used in the diagnostic approach of venous thromboembolism because the sensitivity of this test is insufficient for ruling out the presence of the disease. On the opposite, a low concentration of plasma D-dimer measured by the ELISA method might be used to rule out acute venous thromboembolism, and avoid invasive radiological techniques, especially in patients with an indeterminate probability lung scan.
本研究的目的是评估采用酶联免疫吸附测定(ELISA)法和乳胶凝集试验检测血浆D-二聚体在静脉血栓栓塞症诊断方法中的实用性。在126例疑似肺栓塞(80例)或下肢深静脉血栓形成(46例)的患者中,采用金标准侵入性技术(肺血管造影和/或静脉造影)确诊急性静脉血栓栓塞症的患者占49%。入院当天,血浆D-二聚体浓度高于500 ng/ml用于诊断静脉血栓栓塞症时,ELISA法的敏感性、特异性、阴性预测值和阳性预测值分别为98%、66%、97%、74%,乳胶试验的相应值分别为87%、70%、85%、74%。在51例肺部扫描显示肺栓塞可能性不确定的患者中,ELISA法的敏感性非常高(94%),但乳胶试验的敏感性较低(67%)。入院后第2天和第4天重复检测D-二聚体对ELISA法和乳胶试验的敏感性无显著影响。我们的结果表明,在静脉血栓栓塞症的诊断方法中不应使用乳胶试验检测血浆D-二聚体浓度,因为该试验的敏感性不足以排除疾病的存在。相反,ELISA法测得的低血浆D-二聚体浓度可用于排除急性静脉血栓栓塞症,避免采用侵入性放射学技术,尤其是在肺部扫描可能性不确定的患者中。