Thromb Haemost 2000; 84(02): 156-159
DOI: 10.1055/s-0037-1613991
Rapid Communications
Schattauer GmbH

Rapid ELISA Assay for Plasma D-Dimer in the Diagnosis of Segmental and Subsegmental Pulmonary Embolism

A Comparison with Pulmonary Angiography
Paul E. Sijens
1   From the Department of Radiology, Rotterdam, The Netherlands
,
Huub E. van Ingen
2   Department of Clinical Chemistry, University Hospital Rotterdam, Daniel den Hoed Cancer Center, Rotterdam, The Netherlands
,
Edwin J. R. van Beek
3   The Section of Academic Radiology, Royal Hallamshire Hospital, Sheffield, United Kingdom
,
Arie Berghout
4   The Department of Internal Medicine Zuiderziekenhuis, Rotterdam, The Netherlands
,
Matthijs Oudkerk
1   From the Department of Radiology, Rotterdam, The Netherlands
› Author Affiliations
We thank Jolie van Driel for carrying out the D-dimer tests and BioMerieux France for providing the miniVIDAS system and reagent kits.
Further Information

Publication History

Received 28 October 1999

Accepted after resubmission 17 April 2000

Publication Date:
14 December 2017 (online)

Summary

Study objective To assess the accuracy of a rapid ELISA D-dimer assay for the exclusion of pulmonary embolism (PE) in patients suspected of PE, using pulmonary angiography alone as reference method rather than a diagnostic strategy including lung scintigraphy and leg vein ultrasonography. Methods In 342 patients who were examined by pulmonary angiography to diagnose or exclude PE, the accuracy of the quantitative rapid VIDAS D-dimer test for the exclusion of PE was evaluated retrospectively. D-dimer levels were assayed in frozen samples collected during the diagnostic work-up at the time of pulmonary angiography while on treatment with unfractionated heparin for 1-2 days. Results Mean plasma D-dimer concentrations were increased in patients with angiographic evidence of PE (P <0.0001). The sensitivity of D-dimer for segmental PE was 98%, its accuracy in excluding segmental PE was 99%, higher than the respective figures for subsegmental PE (76% and 94%; P <0.01, both). For both forms of PE combined the sensitivity was 90% and the negative predictive value 94%. Discussion The sensitivity and negative predictive values reported here, are low compared with previous studies using the same rapid ELISA D-dimer assay. This probably reflects an overlooking of mild cases of subsegmental PE in previous studies, although a reduction of D-dimer levels by the heparin pretreatment may have contributed to part of the discrepancy. Prospective studies are needed to clarify this issue.

 
  • References

  • 1 The PIOPED investigators. Value of the ventilation-perfusion scan in acute pulmonary embolism diagnosis (PIOPED). JAMA 1990; 263: 2753-9.
  • 2 Hull RD, Hirsh J, Carter CJ, Jay RM, Dodd PE, Ockelford PA, Coates G, Gill CJ, Turpie AG, Doyle DJ, Buller HR, Raskob GE. Pulmonary angiography, ventilation lung scanning and venography for clinically suspected pulmonary embolism with abnormal perfusion lung scan. Ann Intern Med 1993; 98: 891-9.
  • 3 Oudkerk M, van Beek EJR, van Putten WJL, Büller HR. Cost-effectiveness analysis of various strategies in the diagnostic management of pulmonary embolism. Arch Intern Med 1993; 153: 947-54.
  • 4 Perrier A, Demarais S, Miron MJ, de Moerloose P, Lepage R, Slosman D, Didier D, Unger PF, Patenaude JV, Bounameaux H. Non-invasive diagnosis of venous thromboembolism in outpatients. Lancet 1999; 353: 190-5.
  • 5 van Beek EJ, Schenk BE, Michel BC, van den Ende B, Brandjes DP, van der Heide YT, Bossuyt PM, Buller HR. The role of plasma D-dimers concentration in the exclusion of pulmonary embolism. Br J Haematol 1996; 92: 725-32.
  • 6 van der Meer FJM, Rosendaal FR, Vandenbroucke JP, Briët E. Bleeding complications in oral anticoagulant therapy: an analysis of risk factors. Arch Intern Med 1993; 153: 1557-62.
  • 7 Levine MN, Hirsh J, Landefeld S, Raskob G. Hemorrhagic complications of anticoagulant treatment. Chest 1992; 102: 352S-363S.
  • 8 Rowbotham BJ, Egerton-Vernon J, Whitaker AN, Elms MJ, Bunce IH. Plasma cross linked fibrin degradation products in pulmonary embolism. Thorax 1990; 45: 684-7.
  • 9 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.
  • 10 van Beek EJR, van den Ende B, Berckmans RJ, van der Heide Y, 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.
  • 11 Bounameaux H, Cirafici P, de Moerloose P, Slosman D, Reber G, Unger PF. Measurement of D-dimer in plasma as diagnostic aid in suspected pulmonary embolism. Lancet 1991; 337: 196-200.
  • 12 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.
  • 13 Janssen MCH, Heebels AE, de Merz M. et al. Reliability of five rapid Ddimer assays commpared to ELISA in the execution of deep venous thrombosis. Thromb Haemost 1997; 77: 262-6.
  • 14 Bounameaux H, Schneider PA, Slosman D, de Moerloose P, Reber G. Plasma D-dimer in suspected pulmonary embolism: a comparison with pulmonary angiography and ventilation-perfusion scintigraphy. Blood Coag Fibrinol 1990; 01: 577-9.
  • 15 Goldhaber SZ, Simons GR, Elliot CG, Haire WD, Toltzis R, Blacklow SC, Doolittle MH, Weinberg DS. Quantitative plasma D-dimer levels among patients undergoing pulmonary angiography for suspected pulmonary embolism. JAMA 1993; 270: 2819-22.
  • 16 Pittet JL, de Moerloose Ph, Reber G, Durand C, Villard N, Piga N, Rolland D, Comby S, Dupuy G. VIDAS D-dimer test: fast quantitative ELISA for measuring D-dimer in plasma. Clin Chem 1996; 42: 410-5.
  • 17 de Moerloose P, Desmarais S, Bounameaux H, Reber G, Perrier A, Dupuy G, Pittet JL. Contribution of a new rapid, individual and quantitative automated D-dimer ELISA to exclude pulmonary embolism. Thromb Haemost 1996; 75: 11-3.
  • 18 Oser RF, Zuckerman DA, Gutierrez FR, Brink JA. Anatomic distribution of pulmonary emboli at pulmonary angiography: implications for crosssectional imaging. Radiology 1996; 199: 31-5.
  • 19 Speiser W, Mallek R, Koppensteiner R, Stümpflen A, Kapiotis S, Minar E, Ehringer H, Lechner K. D-dimer and TAT measurement in patients with deep venous thrombosis: utility in diagnosis and judgement of anticoagulant treatment effectiveness. Thromb Haemost 1990; 64: 196-201.
  • 20 Middema M, ten cate H, van Beek EJR, van den Ende A, Hack CE, Brandjes DPM. Effects of anticoagulant treatment on fibrinolysis in patients with suspected pulmonary embolism. Thromb Haemost 1997; 77: 1164-7.
  • 21 Quin DA, Fogel RB, Smith CD, Laposota M, Taylor BThompson, Johnson SM, Waltman AC, Hales CA. D-dimers in the diagnosis of pulmonary embolism. Am J Respir Crit Care Med 1999; 159: 1445-9.