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

P. Meijer; C. Kluft

doi:10.1055/s-2005-922477

Seminars in Vascular Medicine, Inhaltsverzeichnis

Semin Vasc Med 2005; 05(4): 321-327
DOI: 10.1055/s-2005-922477

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

Abstract

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

Volltext

Referenzen

REFERENCES

1 Dempfle C E, Zips S, Ergül H, Heene D L. (on behalf of the FACT study group) . The Fibrin Assay Comparison Trial (FACT). Evaluation of 23 quantitative D-dimer assays as basis for the development of D-dimer calibrators. Thromb Haemost. 2001; 85 671-678
2 Amiral J, Minard F, Plassart V, Vissac A M, Chambrette B. Reactivity of D-dimer assays with the fibrinogen-fibrin split products generated by thrombolytic agents. Blood Coagul Fibrinolysis. 1990; 1 525-530
3 Ellis D R, Eaton A S, Plank M C, Butman B T, Ebert R F. A comparative evaluation of ELISAs for D-dimer and related fibrin(ogen) degradation products. Blood Coagul Fibrinolysis. 1993; 4 537-549
4 Legnani C, Pancani C, Palareti G et al.. Comparison of new rapid methods for D-dimer measurement to exclude deep vein thrombosis in symptomatic outpatients. Blood Coagul Fibrinolysis. 1997; 8 296-302
5 Pittet J L, De Moerloose Ph, Reber G et al.. Vidas D-dimer: fast quantitative ELISA for measuring D-dimer in plasma. Clin Chem. 1996; 42 410-415
6 Janssen M C, Heebels A E, de Metz M et al.. Reliability of five rapid D-dimer assays compared to ELISA in the exclusion of deep venous thrombosis. Thromb Haemost. 1997; 77 262-266
7 Lehman C M, Wilson L W, Rodgers G M. Analytic validation and clinical evaluation of the STA LIATEST immunoturbidimetric D-dimer assay for the diagnosis of disseminated intravascular coagulation. Am J Clin Pathol. 2004; 122 178-184
8 Schutgens R E, Haas F J, Ruven H J, Spannagl M, Horn K, Biesma D E. No influence of heparin and other (pre)analytic varia on D-dimer determinations. Clin Chem. 2002; 48 1611-1613
9 Dempfle C, Schraml M, Besenthal I et al.. Multicentre evaluation of a new point-of-care test for the quantitative determination of D-dimer. Clin Chim Acta. 2001; 307 211-218
10 Reber G, Bounameaux H, Perrier A, De Moerloose P. A new rapid point-of-care D-dimer enzyme-linked immunosorbent assay (Stratus CS D-dimer) for the exclusion of venous thromboembolism. Blood Coagul Fibrinolysis. 2004; 15 435-438
11 Freyburger G, Trillaud H, Labrouche S, Gauthier P, Javorschi S, Bernard P, Grenier N. D-dimer strategy in thrombosis exclusion. A gold standard study in 100 patients suspected of deep venous thrombosis or pulmonary embolism: 8 DD methods compared. Thomb Haemost. 1998; 79 32-37
12 Van der Graaf F, van den Borne H, van der Kolk M, de Wild PJ, Janssen GW, van Uum SH. Exclusion of deep venous thrombosis with D-dimer testing-comparison of 13 D-dimer methods in 99 outpatients suspected of deep venous thrombosis using venography as reference standard. Thromb Haemost. 2000; 83 191-198
13 De Maat M P, Meijer P, Nieuwenhuizen W, Haverkate F, Kluft C. Performance of semiquantitative and quantitative D-dimer assays in the ECAT external quality assessment programme. Semin Thromb Hemost. 2000; 26 625-630
14 Spannagl M, Haverkate F, Reinauer H, Meijer P. The performance of quantitative D-dimer assays in daily laboratory routine. Blood Coag Fibrinolysis. , In press
15 Reber G, De Moerloose P H. D-dimer assays for the exclusion of venous thromboembolism. Semin Thromb Hemost. 2000; 26 619-624
16 Marder V J, Francis C W. Plasmin degradation of cross-linked fibrin. Ann N Y Acad Sci. 1983; 408 397-406
17 Gaffney P J, Edgell T, Creighton-Kempsford L J, Wheeler S, Tarelli E. Fibrin degradation products (FnDP) assay: analysis of standardization issues and target antigens in plasma. Br J Haematol. 1995; 90 187-194
18 Gaffney P J. Fibrin degradation products. A review of structures found in vitro and in vivo. Ann N Y Acad Sci. 2001; 936 594-610
19 Sidelmann J J, Gram J, Jespersen J, Kluft C. Fibrin clot formation and lysis: basic mechanisms. Semin Thromb Hemost. 2000; 26 605-618
20 Walker J B, Nesheim M E. The molecular weights, mass distribution, chain composition, and structure of soluble fibrin degradation products released from a fibrin clot perfused with plasmin. J Biol Chem. 1999; 274 5201-5212
21 Gosselin R C, Owings J T, Kehoe J et al.. Comparison of six D-dimer methods in patients suspected of deep vein thrombosis. Blood Coagul Fibrinolysis. 2003; 14 545-550
22 Schutgens R E, Haas F J, Gerritsen W B, van der Horst F, Nieuwenhuizen H K, Biesma D H. The usefulness of five D-dimer assays in the exclusion of deep venous thrombosis. J Thromb Haemost. 2003; 1 976-981
23 Barrowcliffe T W. Standardization and assay. Semin Thromb Hemost. 1993; 19 73-79
24 Steiner J, Braun P, Byrd P. A comparison of three quantitative assays for fibrin degradation products and D-dimer. Thromb Haemost. 1993; 69 835 (Abstract)
25 Kluft C, Meijer P. Limited co-variation of fibrin degradation products determined by different methods: a comparison of basal levels in two groups of women (abstract). BioMed Central. http://Available at: www.biomedcentral.com/abstracts/crp/1/025
26 ICTH/ICSH . Prothrombin time standardisation: report of the expert panel on oral anticoagulant control. Thromb Haemost. 1979; 42 1073-1114
27 Poller L. Prothrombin t(PT). In: Jespersen J, Bertina RM, Haverkate F Laboratory Techniques in Thrombosis. A Manual of ECAT Assay Procedures. 2nd rev ed. Kluwer Academic Publishers 1999: 45-62
28 Nieuwenhuizen W. A reference material for harmonisation of D-dimer assays. Thromb Haemost. 1997; 77 1031-1033
29 Koopman J, Haverkate F, Koppert P W, Nieuwenhuizen W, Brommer E J, van der Werf W G. New immunoassay for fibrin-fibrinogen degradation products in plasma using a monoclonal antibody. J Lab Clin Med. 1987; 109 75-84

Dr.
P. Meijer

ECAT Foundation, P.O. Box 2215

2301 CE Leiden, The Netherlands