Clinical Evaluation of an Immunoturbidimetric D-Dimer Assay in the Diagnostic Procedure of Deep Vein Thrombosis and Pulmonary Embolism

• Published in: Thrombosis research 1997-12, Vol.88 (5), p.413-417
• Main Authors: Knecht, Markus F, Heinrich, Fritz
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Biological and medical sciences; Cardiovascular system; D-dimer; Deep vein thrombosis; Enzyme-Linked Immunosorbent Assay; Female; Fibrin degradation products; Fibrin Fibrinogen Degradation Products; Humans; Investigative techniques, diagnostic techniques (general aspects); Male; Medical sciences; Middle Aged; Nephelometry and Turbidimetry; Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques; Pulmonary embolism; Pulmonary Embolism - diagnosis; Thrombophlebitis - diagnosis
• ISSN: 0049-3848; 1879-2472
• DOI: 10.1016/S0049-3848(97)00276-4

We investigated 128 patients with suspected deep vein thrombosis and 26 patients with suspected pulmonary embolism. Plasma cross-linked fibrin degradation products were measured instantly by a new rapid and fully quantitative immunoturbidimetric assay (Boehringer Mannheim) which recognizes the D-dimer epitope by antibody-coated latex particles. Diagnosis of deep vein thrombosis was established by either ascending venography (n=105) or colour duplex ultrasound (n=8), whereas for the exclusion of deep vein thrombosis only venography was accepted. The sensitivity/specificity for the diagnosis of deep vein thrombosis was 98% 44% . Patients with suspected pulmonary embolism were examined by pulmonary angiography (n=19) or perfusion lung scanning alone (n=6), if sufficient. One pulmonary embolism was diagnosed at post-mortem examination. For pulmonary embolism, sensitivity/specificity was 100% 50% . These findings indicate that the new immunoturbidimetric technique is as reliable as former ELISA methods and allows to rule out thromboembolic disorders. D-dimers showed a correlation to the extent of the deep vein thrombosis, proximal thrombosis producing higher D-dimer levels. Patients presenting immediately after the onset of symptoms were found to have higher D-dimers than patients examined after a few days. A quantitative D-dimer measurement thus seems to provide precious additional information of the duration and the extent of thromboembolic disease.