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Semin Thromb Hemost 2006; 32(7): 678-693
DOI: 10.1055/s-2006-951296
Copyright © 2006 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA.

Different Accuracies of Rapid Enzyme-Linked Immunosorbent, Turbidimetric, and Agglutination D-Dimer Assays for Thrombosis Exclusion: Impact on Diagnostic Work-Ups of Outpatients with Suspected Deep Vein Thrombosis and Pulmonary Embolism

Jan J. Michiels1 , 7 , Alain Gadisseur1 , Marc van der Planken2 , Wilfried Schroyens1 , Marianne De Maeseneer3 , Jan T. Hermsen4 , Paul H. Trienekens4 , Henk Hoogsteden5 , Peter M.P Pattynama6
  • 1Hemostasis and Thrombosis Research, Department of Hematology, University Hospital Antwerp, Belgium
  • 2Hemostasis Laboratory Department of Clinical Biology, University Hospital Antwerp, Belgium
  • 3Vascular Laboratory, Department of Vascular Surgery, University Hospital Antwerp, Belgium
  • 4Medical Diagnostic Center Rijnmond, Rotterdam, The Netherlands
  • 5Department of Pulmonology, Erasmus Medical Center, Rotterdam, The Netherlands
  • 6Department of Radiology, Erasmus Medical Center, Rotterdam, The Netherlands
  • 7Goodheart Institute, Hematology, Hemostasis & Thrombosis Science Center, Rotterdam, The Netherlands
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Publication History

Publication Date:
06 October 2006 (online)

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ABSTRACT

The requirement for a safe diagnostic strategy should be based on an overall posttest incidence of venous thromboembolism (VTE) of less than 1%, with a negative predictive value of more than 99 to 100% during 3-month follow-up. Compression ultrasonography (CUS) and spiral computed tomography (CT) currently are the methods of choice to confirm or rule out deep venous thrombosis (DVT) and pulmonary embolism (PE), respectively. CUS has a negative predictive value (NPV) of 97 to 98%, indicating the need to improve the diagnostic work-up of patients with suspected DVT by clinical score assessment and D-dimer testing. Spiral CT as a stand-alone method detects all clinically relevant PEs and a large number of alternative diagnoses. It rules out PE with a NPV of 98 to 99%. Spiral CT is expensive, emphasizing the need to improve the diagnostic work-up of patients with suspected PE by the use of clinical score assessment and D-dimer testing. Clinical score assessment for DVT and PE has not safely ruled out VTE in multicenter studies and in routine daily practices. Modification of the Wells clinical score assessment for DVT by elimination of the “minus 2 points” for alternative diagnosis will improve the reproducibility of the clinical score assessment. The combination of a first negative CUS and a negative SimpliRed or an enzyme-linked immunosorbent assay (ELISA) VIDAS D-dimer of < 1,000 ng/mL safely exclude DVT (NPV > 99%) irrespective of clinical score assessment and without the need to repeat CUS in ~60 to 70% of patients. The rapid quantitative and qualitative agglutination D-dimer assays for the exclusion of VTE are not sensitive enough as stand-alone tests and should be used in combination with clinical score assessment. A normal rapid ELISA VIDAS D-dimer test as a stand-alone test safely excludes DVT and PE, with a NPV of 99 to 100%, irrespective of clinical score, without the need of CUS or spiral CT. The combined strategy of a rapid ELISA VIDAS D-dimer followed by objective testing with CUS for DVT and by spiral CT for PE will reduce the need for noninvasive imaging techniques by 40 to 50%.

KEYWORDS

Deep vein thrombosis - pulmonary embolism - D-dimer assay - compression ultrasonography - clinical score - ventilation perfusion scan - spiral computed tomography

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Jan J MichielsM.D. Ph.D. 

Goodheart Institute & Foundation, Hematology Hemostasis Thrombosis Science Center, Erasmus Tower

Veenmos 13, 3069 AT Rotterdam, The Netherlands

Email: postbus@goodheartcenter.demon.nl