Semin Vasc Med 2005; 05(4): 328-339
DOI: 10.1055/s-2005-922478
Copyright © 2005 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA.

Comparability of D-Dimer Assays in Clinical Samples

Geneviève Freyburger1 , 2 , Sylvie Labrouche2
  • 1Laboratoire d'Hématologie, Hôpital Pellegrin, 33076 Bordeaux cedex, France
  • 2E.A. 3670, Université Victor Segalen, 33076 Bordeaux cedex, France
Further Information

Publication History

Publication Date:
22 November 2005 (online)

ABSTRACT

D-dimers (DD) have shown sufficient proof of their efficiency in the last 10 years to play an important role in hemostasis laboratories for excluding thromboembolic events. Numerous reagents are available on the market but their performances differ. This overview takes stock of the methods used to evaluate the performances of DD assays, the results published in the literature, the technical parameters influencing assay performance, the difficulties caused by the lack of harmonization of DD units, and the attempts to tackle this problem. It raises the issue of the potential optimization of their use with regard to better adaptation to multidisciplinary diagnostic strategies and to target patient populations.

REFERENCES

  • 1 Raimondi P, Bongard O, de Moerloose P, Reber G, Waldvogel F, Bounameaux H. D-dimer plasma concentration in various clinical conditions: implication for the use of this test in the diagnostic approach of venous thromboembolism.  Thromb Res. 1993;  69 125-130
  • 2 Mottier D, Coutureaud F, Oger E, Leroyer C. Clinical usefulness of D-dimer tests in excluding pulmonary embolism is highly dependent upon age.  Thromb Haemost. 1998;  80 527
  • 3 Cadroy Y, Grandjean H, Pichon J et al.. Evaluation of six markers of haemostatic system in normal pregnancy and pregnancy complicated by hypertension or pre-eclampsia.  Br J Obstet Gynaecol. 1993;  100 416-420
  • 4 Cooke E D, Bowcock S A, Pilcher M F et al.. Serum fibrin(ogen) degradation products in diagnosis of deep-vein thrombosis and pulmonary embolism after hip surgery.  Lancet. 1975;  2 51-54
  • 5 Rowbotham B J, Carroll P, Whitaker A N et al.. Measurement of crosslinked fibrin derivatives-use in the diagnosis of venous thrombosis.  Thromb Haemost. 1987;  57 59-61
  • 6 Heaton D C, Billings J D, Hickton C M. Assessment of D dimer assays for the diagnosis of deep vein thrombosis.  J Lab Clin Med. 1987;  110 588-591
  • 7 Perrier A, Desmarais S, Miron M J et al.. Non-invasive diagnosis of venous thromboembolism in outpatients.  Lancet. 1999;  353 190-195
  • 8 Wells P S, Hirsh J, Anderson D R et al.. A simple clinical model for the diagnosis of deep-vein thrombosis combined with impedance plethysmography: potential for an improvement in the diagnostic process.  J Intern Med. 1998;  243 15-23
  • 9 Wells P S, Anderson D R, Rodger M et al.. Excluding pulmonary embolism at the bedside without diagnostic imaging: management of patients with suspected pulmonary embolism presenting to the emergency department by using a simple clinical model and d-dimer.  Ann Intern Med. 2001;  135 98-107
  • 10 Wells P S, Anderson D R, Rodger M. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis.  N Engl J Med. 2003;  349 1227-1235
  • 11 Bossuyt PMM. D-dimer testing and venous thromboembolism: four view points.  J Thromb Haemost. 2005;  3 379-380
  • 12 Reber G, Bounameaux H, Perrier A, de Moerloose P. Evaluation of advanced D-dimer assay for the exclusion of venous thrombosis.  Thromb Res. 2002;  107 197-200
  • 13 Wilson D, Gard K. Evaluation of an automated, latex-enhanced turbidimetric D-dimer test (advanced D-dimer) and usefulness in the exclusion of acute thromboembolic disease.  Am J Clin Pathol. 2003;  120 930-937
  • 14 D-Dimer Comparison Trial .A co-operative study of the international external quality assessment organisation ECAT Foundation (P. Meijer) and the German EQA organisation INSTAND (M. Spannagl). Leiden, The Netherlands; ECAT Foundation 2001
  • 15 Freyburger G, Trillaud H, Labrouche S, Gauthier P, Javorschi S, Grenier N. D-dimer and thrombosis exclusion. A gold standard study in 100 patients suspected of deep venous thrombosis or pulmonary embolism: 8 methods compared.  Thromb Haemost. 1998;  79 32-37
  • 16 van der Graaf F, van den Borne H, van der Kolk M, de Wild P J, Janssen G W, van Uum S H. 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
  • 17 Pittet J L, de Moerloose P, Reber G. VIDAS D-dimer: fast quantitative ELISA for measuring D-dimer in plasma.  Clin Chem. 1996;  42 410-415
  • 18 Dempfle C E, Zips S, Ergül H, Heene D L. The Fibrin Assay Comparison Trial Study Group . The fibrin assay comparison trial (FACT): evaluation of 23 quantitative D-dimer assays as basis for the development of D-dimer calibrators. FACT study group.  Thromb Haemost. 2001;  85 671-678
  • 19 Dempfle C E. D-dimer testing and venous thromboembolism: four view points.  J Thromb Haemost. 2005;  3 377-379
  • 20 Meijer P, Kluft C. The harmonisation of quantitative test results of different D-dimer methods.  Semin Vasc Med. 2005;  5 321-327
  • 21 Freyburger G, Trillaud H, Labrouche S, Gauthier P, Javorschi S, Grenier N. Rapid ELISA D-dimer testing in the exclusion of venous thromboembolism in hospitalized patients.  Clin Appl Thromb Hemost. 2000;  6 77-81
  • 22 Stein P D, Hull R D, Patel K C et al.. D-dimer for the exclusion of acute venous thrombosis and pulmonary embolism: a systematic review.  Ann Intern Med. 2004;  140 589-602
  • 23 Heim S W, Schectman J M, Siadaty M S, Philbrick J T. D-dimer testing for deep venous thrombosis: a metaanalysis.  Clin Chem. 2004;  50 1136-1147
  • 24 Brown M D, Lau J, Nelson R D, Kline J A. Turbidimetric D-dimer test in the diagnosis of pulmonary embolism: a metaanalysis.  Clin Chem. 2003;  49 1846-1853
  • 25 Brown M D, Rowe B H, Reeves M J, Bermingham J M, Goldhaber S Z. The accuracy of the enzyme-linked immunosorbent assay D-dimer test in the diagnosis of pulmonary embolism: a meta-analysis.  Ann Emerg Med. 2002;  40 133-144
  • 26 de Moerloose P, Bounameaux H, Wells P H. D-dimer testing and venous thromboembolism: four view points.  J Thromb Haemost. 2005;  3 380-382
  • 27 Perrier A, Palareti G. D-dimer testing and venous thromboembolism: four view points.  J Thromb Haemost. 2005;  3 382-384
  • 28 Linkins L A, Bates S M, Ginsberg J S, Kearon C. Use of different D-dimer levels to exclude venous thromboembolism depending on clinical pretest probability.  J Thromb Haemost. 2004;  2 1256-1260
  • 29 Abcarian P W, Sweet J D, Watabe J T, Yoon H C. Role of a quantitative D-dimer assay in determining the need for CT angiography of acute pulmonary embolism.  AJR Am J Roentgenol. 2004;  182 1377-1381
  • 30 Righini M, Aujesky D, Roy P M et al.. Clinical usefulness of D-dimer depending on clinical probability and cutoff value in outpatients with suspected pulmonary embolism.  Arch Intern Med. 2004;  164 2483-2487
  • 31 Keeling D M, Mackie I J, Moody A, Watson H G. The Haemostasis and Thrombosis Task Force of the British Committee for Standards in Haematology. The diagnosis of deep vein thrombosis in symptomatic outpatients and the potential for clinical assessment and D-dimer assays to reduce the need for diagnostic imaging.  Br J Haematol. 2004;  124 15-25

Geneviève FreyburgerM.D. 

Laboratoire d'Hématologie, Hôpital Pellegrin

33076 Bordeaux cedex, France

    >