The use of a fixed high sensitivity to evaluate five D-dimer assays' ability to rule out deep venous thrombosis: a novel approach

Br J Haematol. 2005 Nov;131(3):341-7. doi: 10.1111/j.1365-2141.2005.05774.x.

Abstract

Suspected deep venous thrombosis (DVT) is difficult to refute without complex diagnostic algorithms and expensive testing. We analysed five D-dimer assays' utility for exclusion of suspected DVT during a prospective clinical cohort trial, choosing a highly sensitive cut-off value at which to compare the assays. Assays were performed on 436 consecutive patients who were referred with symptoms that suggested a first episode of DVT. Venous thromboembolism (VTE) was defined as positive findings on comprehensive duplex ultrasonography or any episode, or complication of VTE detected during 3 months of clinical follow-up. All five assays were performed in 377 patients. At a highly sensitive cut-off value, all five assays reliably excluded DVT in the study population. While the choice of a highly sensitive cut-off value reduced the specificity of all the assays, the change in specificity differed between tests. Our findings suggest that a second-generation D-dimer assay could be used as a stand-alone test to rule out suspected DVT when a highly sensitive cut-off value is chosen. These findings should be subjected to a prospective management study, as a small reduction in sensitivity from our findings could result in a clinically relevant decrease in negative predictive value.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adult
  • Aged
  • Biomarkers / blood
  • Female
  • Fibrin Fibrinogen Degradation Products / analysis*
  • Humans
  • Immunoassay / methods
  • Male
  • Middle Aged
  • Prospective Studies
  • Sensitivity and Specificity
  • Ultrasonography
  • Venous Thrombosis / diagnosis*
  • Venous Thrombosis / diagnostic imaging

Substances

  • Biomarkers
  • Fibrin Fibrinogen Degradation Products
  • fibrin fragment D