Download PDF
Thromb Haemost 2000; 83(02): 191-198
DOI: 10.1055/s-0037-1613784
Rapid Communication
Schattauer GmbH

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
Fedde van der Graaf
1   From the Clinical Laboratories, Veldhoven, The Netherlands
,
Henk van den Borne
2   From the Department of Radiodiagnostics, Veldhoven, The Netherlands
,
Marion van der Kolk
3   Surgery, Veldhoven, The Netherlands
,
Piet J. de Wild
1   From the Clinical Laboratories, Veldhoven, The Netherlands
,
Ger W. T. Janssen
1   From the Clinical Laboratories, Veldhoven, The Netherlands
,
Stan H. M. van Uum
4   Internal Medicine of the Sint Joseph Hospital, Veldhoven, The Netherlands
› Author Affiliations
Further Information

Publication History

Received 27 May 1999

Accepted after revision 01 September 1999

Publication Date:
11 December 2017 (online)

    Permissions and Reprints

Summary

In a direct assay comparison we evaluated the diagnostic performance of 10 novel D-Dimer assays for the exclusion of deep venous thrombosis (DVT). In addition, 3 conventional ELISA D-Dimer assays were included as reference tests. The study was performed in 99 consecutive outpatients referred to the emergency department for clinical suspicion of DVT. Venography was used as reference standard and demonstrated the presence of DVT in 50 patients (6 patients with isolated distal DVT and 44 patients with proximal DVT). The qualitative D-Dimer assays Minutex and SimpliRED and the quantitative BC DD showed overall sensitivities (for proximal and distal DVT) of only 80-83% with specificities that ranged from 87 to 94%. Overall sensitivity was 94% for the qualitative INSTANT I.A. and 98% for the quantitative Turbiquant at a cut-off level equal to the detection limit. Using different cut-off levels a sensitivity of 100% for proximal DVT and for proximal as well as distal DVT could be obtained for NycoCard, IL DD, Liatest, Tinaquant and VIDAS D-Dimer assays with specificities that ranged from 31% (NycoCard) to 71% (VIDAS) for proximal DVT and from 12% (NycoCard) to 47% (IL DD) for overall DVT. At a cut-off level equal to the upper limit of the reference range only Tinaquant and VIDAS showed a sensitivity of 100% for proximal as well as for distal DVT with a specificity of 39% and 41% respectively.

The results of this study suggest that the VIDAS and Tinaquant D-Dimer assays have the highest sensitivity for the exclusion of DVT in outpatients. In outpatients that have a low or moderate pretest probability for DVT, these tests may be used in management studies where anticoagulation is withheld on the basis of D-Dimer testing alone.

Keywords

Deep venous thrombosis - D-Dimer
 

  • References

  • 1 Rylatt DB, Blake AS, Cottis LE, Massingham DA, Fletcher WA, Masci PP, Whitaker AN, Elms MJ, Bunce IH, Webber AJ, Wyatt D, Bundesen PG. An immunoassay for human D-Dimer using monoclonal antobodies. Thromb Res 1983; 31: 767-78.
    CrossrefPubMedGoogle Scholar
  • 2 Gaffney PJ, Creighton LJ, Callus MJ, Thorpe R. Monoclonal antibodies to crosslinked fibrin degradation products (XL-FDP). II Evolution in a variety of clinical conditions. Br J Haematol 1988; 68: 91-6.
    CrossrefPubMedGoogle Scholar
  • 3 Rowbotham BJ, Carrol P, Withaker AN, Bunce IH, Cobcroft RG, Elms MJ, Masci PP, Bundesen PG, Rylatt DB, Webber AJ. Measurement of crosslinked fibrin derivatives-Use in the diagnosis of deep venous thrombosis. Thromb Haemost 1987; 57: 59-61.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 4 Bounameaux H, de Moerloose P, Perrier A, Reber G. Plasma measurement of D-Dimer as diagnostic aid in suspected venous thromboembolism: an overview. Thromb Haemost 1994; 71: 1-6.
    PubMedGoogle Scholar
  • 5 Rabinov K, Paulin S. Roentgen diagnosis of venous thrombosis in the leg. Arch Surg 1972; 104: 134-44.
    CrossrefPubMedGoogle Scholar
  • 6 John MA, Elms MJ, O’Reilly EJ, Rylatt DB, Bundesen PG, Hillyard CJ. The SimpliRED D-dimer test: a novel assay for the detection of crosslinked fibrin degradation products in whole blood. Thromb Res 1990; 58: 273-81.
    CrossrefPubMedGoogle Scholar
  • 7 Gogstad GO, Dale S, Brosstad F, Brandsnes Ø, Holtlund J, Mork E, Gärtner E, Borch SM. Assay of D-Dimer based on immunofiltration and staining with gold colloids. Clin Chem 1993; 39: 2070-6.
    PubMedGoogle Scholar
  • 8 Vissac A-M, Grimeaux M, Chartier S, Chan FA, Chambrette B, Amiral J. A new sensitive membrane based ELISA technique for instantaneous D-Dimer evaluation in emergency. Thromb Res 1995; 78: 341-52.
    CrossrefPubMedGoogle Scholar
  • 9 Pittet J-L, de Moerloose P, Reber G, Durand C, Villard C, Piga N, Rolland D, Comby S, Dupuy G. VIDAS D-Dimer: fast quantitative ELISA for measuring D-dimer in plasma. Clin Chem 1996; 42: 410-5.
    PubMedGoogle Scholar
  • 10 Vukovich TC, Hamwi A, Bieglmayer C. D-Dimer testing within the routine clinical chemistry profile. Clin Chem 1998; 44: 1557-8.
    PubMedGoogle Scholar
  • 11 Van Beek EJR, van den Ende B, Berckmans RJ, van der Heide YT, Brandjes DPM, Sturk A, ten Cate JW. A comparative analysis of D-Dimer assays in patients with clinically suspected pulmonary embolism. Thromb Haemost 1993; 70: 408-13.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 12 Scarano L, Bernardi P, Sardella C, Rossi L, Carraro P, Simioni P, Girolami A. Accuracy of two newly described D-Dimer tests in patients with suspected deep venous thrombosis. Thromb Res 1997; 86: 93-9.
    CrossrefPubMedGoogle Scholar
  • 13 Cogo A, Lensing AWA, Hirsch J, ten Cate JW. Distribution of thrombosis in patients with deep-vein thrombosis: implications for simplifying the diagnostic process with compression ultrasound. Arch Intern Med 1993; 153: 2777-80.
    CrossrefPubMedGoogle Scholar
  • 14 Janssen MCH, Heebels AE, de Metz M, Verbruggen H, Wollersheim H, Janssen S, Schuurmans MMJ, Nováková IRO. Reliability of five rapid D-Dimer assays compared to ELISA in the exclusion of deep venous thrombosis. Thromb Haemost 1997; 77: 262-6.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 15 Legnani C, Pancani C, Palareti G, Guazzaloca G, Fortunato G, Grauso F, Golfieri R, Gianpalma E, Coccheri S. Comparison of new rapid methods for D-Dimer measurement to exclude deep vein thrombosis in symptomatic patients. Blood Coagul Fibrinolysis 1997; 08: 296-302.
    CrossrefPubMedGoogle Scholar
  • 16 Escoffre-Barbe M, Oger E, Leroyer C, Grimaux M, Le Moigne E, Nonent M, Bressollette L, Abgrall JF, Soria C, Amiral J, Ill P, Clavier J, Mottier D. Evaluation of a New Rapid D-Dimer Assay for Clinically Suspected Deep Venous Thrombosis (Liatest D-Dimer). Am J Clin Pathol 1998; 109: 748-53.
    CrossrefPubMedGoogle Scholar
  • 17 Hansson PO, Eriksson H, Eriksson E, Jagenburg R, Lukes P, Risberg B. Can laboratory testing improve screening strategies for deep vein thrombosis at an emergency unit?. J Intern Med 1994; 235: 143-51.
    CrossrefPubMedGoogle Scholar
  • 18 Lindahl TL, Lundahl TH, Ranby M, Fransson SG. Clinical evaluation of a diagnostic strategy for deep venous thrombosis with exclusion by low plasma levels of fibrin degradation product D-dimer. Scand J Clin Lab Invest 1998; 58: 307-16.
    CrossrefPubMedGoogle Scholar
  • 19 Tengborn L, Palmblad S, Wojciechowski J, Peterson LE, Stigendal L. D-Dimer and Thrombin/Antithrombin III Complex-Diagnostic Tools in Deep Venous Thrombosis?. Haemostasis 1994; 24: 344-50.
    PubMedGoogle Scholar
  • 20 Wells PS, Brill-Edwards P, Stevens P, Panju A, Patel A, Douketis J, Massicotte P, Hirsh J, Weitz JI, Kearon C, Ginsberg JS. A Novel and Rapid Whole-Blood Assay for D-Dimer in Patients With Clinically Suspected Deep Vein Thrombosis. Circulation 1995; 91: 2184-7.
    CrossrefPubMedGoogle Scholar
  • 21 Turkstra F, Beek EJR, van Cate JW, ten Büller HR. Reliable Rapid Blood Test for the Exclusion of Venous Thromboembolism in Symptomatic Outpatients. Thromb Haemost 1996; 76: 9-11.
    PubMedGoogle Scholar
  • 22 Ginsberg JS, Kearon C, Douketis J, Turpie AGG, Brill-Edwards P, Stevens P, Panju A, Patel A, Crowther M, Andrew M, Massicotte P, Hirsh J, Weitz JI. The Use of D-Dimer Testing and Impedance Plethysmographic Examination in Patients with Clinical Indications of Deep Vein Thrombosis. Arch Intern Med 1997; 157: 1077-81.
    CrossrefPubMedGoogle Scholar
  • 23 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. Thromb Haemost 1998; 79: 32-7.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 24 Ginsberg JS, Wells PS, Kearon C, Anderson D, Crowther M, Weitz JI, Bormanis J, Brill-Edwards P, Turpie AG, MacKinnon B, Gent M, Hirsh J. Sensitivity and Specificity of a Rapid Whole-Blood Assay for D-Dimer in the Diagnosis of Pulmonary Embolism. Ann Intern Med 1998; 129: 1006-11.
    CrossrefPubMedGoogle Scholar
  • 25 Mauron T, Baumgartner I, Z’Brun A, Demarmels FBiasiutti, Redondo M, Do DD, Lämmle B, Wuillemin WA. SimpliRED D-dimer Assay: Comparability of Capillary and Citrated Venous Whole Blood, Between-assay Variability, and Performance of the Test for Exclusion of Deep Vein Thrombosis in Symptomatic Outpatients. Thromb Haemost 1998; 79: 1217-9.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 26 Elias A, Aptel I, Huc B, Chalé JJ, Nguyen F, Cambus JP, Boccalon H, Boneu B. D-Dimer Test and Diagnosis of Deep Vein Thrombosis: A Comparative Study of 7 Assays. Thromb Haemost 1996; 76: 518-22.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 27 Leroyer C, Escoffre M, Le Moigne E, Grimaux M, Cagnioncle O, Oger E, Bressollette L, Abgrall JF, Amiral J, Mottier D. Diagnostic Value of a New Sensitive Membrane Based Technique for Instantaneous D-Dimer Evaluation in Patients with Clinically Suspected Deep Venous Thrombosis. Thromb Haemost 1997; 77: 637-40.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 28 Tardy B, Tardy-Poncet B, Viallon A, Lafond P, Page Y, Venet C, Bertrand JC. Evaluation of D-dimer ELISA Test in Elderly Patients with Suspected Pulmonary Embolism. Thromb Haemost 1998; 79: 38-41.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 29 Dale S, Gogstad GO, Brosstad F, Godal HC, Holtlund J, Mork E, Brandsnes Ø, Borch SM. Comparison of Three D-Dimer Assays for the Diagnosis of DVT: ELISA, Latex and an Immunofiltration Assay (NycoCard D-Dimer). Thromb Haemost 1994; 71: 270-4.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 30 Veitl M, Hamwi A, Kurtaran A, Virgolini I, Vukovich T. Comparison of four rapid D-Dimer tests for diagnosis of pulmonary embolism. Thromb Res 1996; 82: 399-407.
    CrossrefPubMedGoogle Scholar
  • 31 Killick SB, Pentek PG, Mercieca JE, Clarke MF, Bevan DH. Comparison of immunofiltration assay of plasma D-dimer with diagnostic imaging in deep vein thrombosis. Br J Haematol 1997; 96: 846-9.
    CrossrefPubMedGoogle Scholar
  • 32 Turkstra F, Beek EJR, van Büller HR. Observer and Biological Variation of a Rapid Whole Blood D-Dimer Test. Thromb Haemost 1998; 79: 91-3.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 33 De Moerloose P, Desmarais S, Bounameaux H, Reber G, Perrier A, Dupuy G, Pittet J-L. Contribution of a New, Rapid, Individual and Quantitative Automated D-Dimer ELISA to Exclude Pulmonary Embolism. Thromb Haemost 1996; 75: 11-3.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 34 D’Angelo A, D’Alessandro G, Tomassini L, Pittet J-L, Dupuy G, Crippa L. Evaluation of a New Rapid Quantitative D-dimer assay in Patients with Clinically Suspected Deep Vein Thrombosis. Thromb Haemost 1996; 75: 412-6.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 35 Borg JY, Lévesque H, Cailleux N, Franc C, Hellot MF, Courtois H. Rapid quantitative D-dimer Assay and Clinical Evaluation for the Diagnosis of Clinically Suspected Deep Vein Thrombosis. Thromb Haemost 1997; 77: 600-9.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 36 Perrier A, Desmarais S, Miron M-J, de Moerloose P, Lepage R, Slosman D, Didier D, Unger P-F, Patenaude J-V, Bounameaux H. Non-invasive diagnosis of venous thromboembolism in outpatients. Lancet 1999; 353: 190-5.
    CrossrefPubMedGoogle Scholar
  • 37 Reber G, Bounameaux H, Perrier A, de Moerloose P. Performance of a New, Rapid and Automated Microlatex D-dimer Assay for the exclusion of Pulmonary Embolism in Symptomatic Outpatients. Thromb Haemost 1998; 80: 719-20.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 38 Kario K, Matsuo T, Kobayashi H. Which factors affect D-dimer levels in the elderly. Thromb Res 1992; 62: 501-8.
    PubMedGoogle Scholar
  • 39 Perrier A, Desmarais S, Goehring C, de Moerloose P, Morabia A, Unger P-F, Slosman D, Junod A, Bounameaux H. D-dimer testing for Suspected Pulmonary Embolism in Outpatients. Am J Respir Crit Care Med 1997; 156: 492-6.
    CrossrefPubMedGoogle Scholar
  • 40 Beek EJR, van Schenk BE, Michel BC, Ende B, van den Brandjes DPM, Heide YT, van der Bossuyt PMM, Büller HR. The role of plasma D-dimer concentration in the exclusion of pulmonary embolism. Br J Haematol 1996; 92: 725-32.
    CrossrefPubMedGoogle Scholar
  • 41 Anand SS, Wells PS, Hunt D, Brill-Edwards P, Cook D, Ginsberg JS. Does This Patient Have Deep Vein Thrombosis. JAMA 1998; 279: 1094-9.
    CrossrefPubMedGoogle Scholar