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Semin Vasc Med 2005; 05(4): 321-327
DOI: 10.1055/s-2005-922477
Copyright © 2005 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA.

The Harmonization of Quantitative Test Results of Different D-Dimer Methods

P. Meijer1 , 2 , C. Kluft2
  • 1ECAT Foundation, Gaubius Laboratory, Leiden, The Netherlands
  • 2TNO Quality of Life, Gaubius Laboratory, Leiden, The Netherlands
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Publication History

Publication Date:
22 November 2005 (online)

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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.

KEYWORDS

D-dimer - specificity - standardization - harmonization - venous thrombosis

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 Dr.
P. Meijer

ECAT Foundation, P.O. Box 2215

2301 CE Leiden, The Netherlands