The harmonization of quantitative test results of different D-dimer methods

Semin Vasc Med. 2005 Nov;5(4):321-7. doi: 10.1055/s-2005-922477.


Nowadays D-dimer testing is frequently applied in the diagnosis of venous thromboembolism. However, the test results of different quantitative D-dimer tests can differ significantly. The background of this variability, which is mainly caused by the variety of fibrin degradation products in plasma, the specificity of D-dimer assays, and the calibrators used in the test, is summarized here. Because D-dimer is not a single entity in plasma but a mixture of heterogeneous fibrin degradation products, method standardization is in principle impossible. Efforts undertaken in the past to standardize D-dimer methods are summarized. All these projects failed and it was concluded that only harmonization of D-dimer test results seems to be feasible. The results of a large field study on which a new approach to the harmonization of quantitative D-dimer methods will be based is summarized in this article. This approach seems to be an adequate solution for overcoming the practical problem of variation of test outcome in different D-dimer assays.

Publication types

  • Review

MeSH terms

  • Fibrin Fibrinogen Degradation Products / analysis*
  • Humans
  • Immunoassay / methods
  • Immunoassay / standards*
  • Quality Control
  • Venous Thrombosis / diagnosis*


  • Fibrin Fibrinogen Degradation Products