title: The harmonization of quantitative test results of different D-dimer methods.
abstract: 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.
authors.affiliation: ECAT Foundation, Gaubius Laboratory, Leiden, The Netherlands.
authors.forename: P
authors.initials: P
authors.lastname: Meijer
authors.forename: C
authors.initials: C
authors.lastname: Kluft
mesh_terms: D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D007118:Immunoassay / Q000379:methods / Q000592:standards*; D011786:Quality Control; D020246:Venous Thrombosis / Q000175:diagnosis*
chemical_list: D005338:Fibrin Fibrinogen Degradation Products