Thrombosis Research
Volume 121, Issue 6 , Pages 735-741 , 2008

Diagnostic accuracy of the Triage® D-dimer test for exclusion of venous thromboembolism in outpatients

Received 5 March 2007 ,Revised 5 July 2007 ,Accepted 13 July 2007.

References 

  1. Kyrle PA, Eichinger S. Deep vein thrombosis. Lancet. 2005;365:1163–1174
  2. Goldhaber SZ. Pulmonary embolism. Lancet. 2004;363:1295–1305
  3. Heit JA. The epidemiology of venous thromboembolism in the community: implications for prevention and management. J Thromb Thrombolysis. 2006;21:23–29
  4. Silverstein MD, Heit JA, Mohr DN, Petterson TM, O’Fallon WM, Melton LJ. Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population based study. Arch Intern Med. 1998;158:585–593
  5. Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999;353:1386–1389
  6. Wells PS, Owen C, Doucette S, Fergusson D, Tran H. Does this patient have deep vein thrombosis?. JAMA. 2006;295:199–207
  7. Pineda LA, Hathwar VS, Grant BJ. Clinical suspicion of fatal pulmonary embolism. Chest. 2001;120:791–795
  8. Buller HR, Sohne M, Middeldorp S. Treatment of venous thromboembolism. J Thromb Haemost. 2005;3:1554–1560
  9. Andrews EJ, Fleischer AC. Sonography for deep venous thrombosis: current and future applications. Ultrasound Q. 2005;21:213–225
  10. Zierler BK. Ultrasonography and the diagnosis of venous thromboembolism. Circulation. 2004;109:I9–I14
  11. Nijkeuter M, Huisman MV. Diagnostic methods in pulmonary embolism. Eur J Intern Med. 2005;16:247–256
  12. Kelly J, Rudd A, Lewis RR, Hunt BJ. Plasma D-dimers in the diagnosis of venous thromboembolism. Arch Intern Med. 2002;162:747–756
  13. Kelly J, Hunt BJ. Role of D-dimer in diagnosis of venous thromboembolism. Lancet. 2002;359:456–458
  14. Kelly J, Hunt BJ. A clinical probability assessment and DD measurement should be the initial step in the investigation of suspected venous thromboembolism. Chest. 2003;124:1116–1119
  15. Perrier A, Desmarais S, Miron MJ, de Moerloose P, Lepage R, Slosman D, et al. Non-invasive diagnosis of venous thromboembolism in outpatients. Lancet. 1999;353:190–195
  16. 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
  17. Hogg K, Dawson D, Mackway-Jones K. Outpatient diagnosis of pulmonary embolism: the MIOPED (Manchester Investigation Of Pulmonary Embolism Diagnosis) study. Emerg Med J. 2006;23:123–127
  18. Wells PS, Anderson DR, Rodger M, Forgie M, Kearon C, Dreyer J, et al. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med. 2003;349:1227–1235
  19. Perrier A, Roy PM, Aujesky D, Chagnon I, Howarth N, Gourdier AL, et al. Diagnosing pulmonary embolism in outpatients with clinical assessment, D-dimer measurement, venous ultrasound, and helical computed tomography: a multicenter management study. Am J Med. 2004;116:291–299
  20. Ver Elst K, Jochmans K, De Pauw A, De Waele M. Plasma D-dimer concentrations in different clinical conditions. Acta Clin Belg. 2002;57:325–330
  21. 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
  22. Perrier A. D-dimer for suspected pulmonary embolism: whom should we test?. Chest. 2004;125:807–809
  23. Brotman DJ, Segal JB, Jani JT, Petty BG, Kickler TS. Limitations of D-dimer testing in unselected inpatients with suspected venous thromboembolism. Am J Med. 2003;114:276–282
  24. Schrecengost JE, LeGallo RD, Boyd JC, Moons KG, Gonias SL, Rose CE, et al. Comparison of diagnostic accuracies in outpatients and hospitalized patients of D-dimer testing for the evaluation of suspected pulmonary embolism. Clin Chem. 2003;49:1483–1490
  25. Freyburger G, Trillaud H, Labrouche S, Gauthier P, Javorschi S, Bernard P, et al. D-dimer strategy in thrombosis exclusion — a gold standard study in 100 patients suspected of deep venous thrombosis or pulmonary embolism: 8 D-dimer methods compared. Thromb Haemost. 1998;79:32–37
  26. 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
  27. Pittet JL, de Moerloose P, Reber G, Durand C, Villard C, Piga N, et al. VIDAS D-dimer: fast quantitative ELISA for measuring D-dimer in plasma. Clin Chem. 1996;42:410–415
  28. de Moerloose P, Bounameaux H, Perrier A, Reber G. Performances of the VIDAS D-dimer new assay for the exclusion of venous thromboembolism. Thromb Haemost. 2001;85:185–186
  29. NCCLS . In: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition. NCCLS document EP5-A2. 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087–1898 USA: NCCLS; 2004;
  30. Heijboer H, Buller HR, Lensing AW, Turpie AG, Colly LP, ten Cate JW. A comparison of real-time compression ultrasonography with impedance plethysmography for the diagnosis of deep-vein thrombosis in symptomatic outpatients. N Engl J Med. 1993;329:1365–1369
  31. The PIOPED Investigators . Value of the ventilation/perfusion scan in acute pulmonary embolism. Results of the prospective investigation of pulmonary embolism diagnosis (PIOPED). JAMA. 1990;263:2753–2759
  32. Remy-Jardin M, Remy J, Deschildre F, Artaud D, Beregi JP, Hossein-Foucher C, et al. Diagnosis of pulmonary embolism with spiral CT: comparison with pulmonary angiography and scintigraphy. Radiology. 1996;200:699–706
  33. STARD Group. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD statement. Clin Chem. 2003;49:1–6
  34. Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. J Clin Chem Clin Biochem. 1983;21:709–720
  35. Kramer MS, Feinstein AR. Clinical biostatistics. LIV. The biostatistics of concordance. Clin Pharmacol Ther. 1981;29:111–123
  36. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33:159–174
  37. Goldhaber SZ. Pulmonary embolism. N Engl J Med. 1998;339:93–104
  38. Ransohoff DF, Feinstein AR. Problems of spectrum and bias in evaluating the efficacy of diagnostic tests. N Engl J Med. 1978;299:926–930
  39. Moons KG, Biesheuvel CJ, Grobbee DE. Test research versus diagnostic research. Clin Chem. 2004;50:473–476
  40. Mower WR. Evaluating bias and variability in diagnostic test reports. Ann Emerg Med. 1999;33:85–91
  41. Mulherin SA, Miller WC. Spectrum bias or spectrum effect? Subgroup variation in diagnostic test evaluation. Ann Intern Med. 2002;137:598–602
  42. Bossuyt PM, Lijmer JG, Mol BW. Randomized comparisons of medical tests: sometimes invalid, not always efficient. Lancet. 2000;356:1844–1847
  43. Heim SW, Schectman JM, Siadaty MS, Philbrick JT. D-dimer testing for deep venous thrombosis: a metaanalysis. Clin Chem. 2004;50:1136–1147
  44. Brown MD, Rowe BH, Reeves MJ, Bermingham JM, Goldhaber SZ. 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
  45. Wolfe TR, Hartsell SC. Pulmonary embolism: making sense of the diagnostic evaluation. Ann Emerg Med. 2001;37:504–514
  46. Speiser W, Mallek R, Koppensteiner R, Stumpflen A, Kapiotis S, Minar E, et al. 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
  47. Couturaud F, Kearon C, Bates SM, Ginsberg JS. Decrease in sensitivity of D-dimer for acute venous thromboembolism after starting anticoagulant therapy. Blood Coagul Fibrinolysis. 2002;13:241–246
  48. Dempfle CE, Zips S, Ergul H, Heene DL. Fibrin Assay Comparative 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
  49. Meijer P, Haverkate F, Kluft C, de Moerloose P, Verbruggen B, Spannagl M. A model for the harmonisation of test results of different quantitative D-dimer methods. Thromb Haemost. 2006;95:567–572
  50. Lewandrowski EL, Van Cott EM. Evaluation of the Biosite Triage® Quantitative Whole Blood D-dimer Assay and Comparison With the bioMérieux VIDAS®. D-dimer Exclusion Test. Point of Care. 2005;4:134–137

☆ Poster presented at the BSTH Annual Meeting, Château de Limelette (Brussels, 24/11/06)

PII: S0049-3848(07)00312-X

doi: 10.1016/j.thromres.2007.07.012

Thrombosis Research
Volume 121, Issue 6 , Pages 735-741 , 2008

Article Tools

* Image Usage & Resolution