Clinical evaluation of an immunoturbidimetric D-dimer assay in the diagnostic procedure of deep vein thrombosis and pulmonary embolism

Thromb Res. 1997 Dec 1;88(5):413-7. 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.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Fibrin Fibrinogen Degradation Products*
  • Humans
  • Male
  • Middle Aged
  • Nephelometry and Turbidimetry
  • Pulmonary Embolism / diagnosis*
  • Thrombophlebitis / diagnosis*


  • Fibrin Fibrinogen Degradation Products
  • fibrin fragment D