Download PDF
Thromb Haemost 2000; 83(06): 892-895
DOI: 10.1055/s-0037-1613939
Commentary
Schattauer GmbH

Clinical Evaluation of a Monoclonal Antibody-based Enzyme Immunoassay for Fibrin Degradation Products in Patients with Clinically Suspected Pulmonary Embolism

Melvin R. Mac Gillavry
1   From the Department of Internal Medicine, Slotervaart Hospital, Amsterdam
,
Wouter de Monyé
2   Department of Radiology, Leiden University Medical Center, Leiden
6   Department of General Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
,
Jeroen G. Lijmer
3   Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, Amsterdam
,
Willem Nieuwenhuizen
4   Gaubius Laboratory, TNO Prevention and Health, Leiden
,
Harry R. Büller
5   Department of Vascular Medicine, Academic Medical Center, Amsterdam
,
Menno V. Huisman
6   Department of General Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
,
Dees P. M. Brandjes
1   From the Department of Internal Medicine, Slotervaart Hospital, Amsterdam
5   Department of Vascular Medicine, Academic Medical Center, Amsterdam
,
the ANTELOPE-Study Group › Author AffiliationsFinancial support for this study was provided by the Dutch Health Insurance Council (nr. D094-90) and the Dutch Prevention Fund (nr. 28-2884). Dr. H. R. Büller is an established investigator of the Dutch Heart Foundation.
Further Information

Publication History

Received 01 October 1999

Accepted after resubmission 31 January 2000

Publication Date:
14 December 2017 (online)

    Permissions and Reprints

Summary

We prospectively evaluated the diagnostic accuracy of the Fibrinostika® FbDP assay in 304 consecutive patients with suspected pulmonary embolism and examined potentially useful cut-off points at which the disease can be excluded. The prevalence of pulmonary embolism was 31%. The assay generated an area under the Receiver Operating Characteristic curve of 0.79 (95% CI 0.73–0.84). A cut-off point of 0.05 µ,g/ml yielded a sensitivity, specificity, negative predictive value and an exclusion efficiency of 100% (95% CI 96–100), 5% (95% CI 2–9), 100% (95% CI 69–100) and 3% (95% CI 2–6), respectively. A clinically useful cut-off point seems to be 0.11 µ,g/ml which corresponded with a sensitivity, specificity, negative predictive value and an exclusion efficiency of 96% (95% CI 90–99), 27% (95% CI 24–28), 93% (95% CI 84–98) and 20% (95% CI 16–25), respectively. We conclude that the assay has potential clinical utility for the exclusion of pulmonary embolism, but it cannot be used as a sole test.

Key words

Fibrin degradation products - pulmonary embolism - diagnosis

* Participating investigators are listed in the appendix, please see p. 895.


 

  • References

  • 1 Doolittle RF. Fibrinogen and fibrin. Sci Am 1981; 245: 92-101.
    PubMedGoogle Scholar
  • 2 Sasaki T, Page IH, Shainoff JR. Soluble complexes of fibrinogen and fibrin. Science 1996; 152: 1069-71.
    PubMedGoogle Scholar
  • 3 Graeff H, Hafter R. Detection and relevance of crosslinked fibrin derivatives in blood. Sem Thromb Haemostas 1982; 08: 57-68.
    PubMedGoogle Scholar
  • 4 Francis CW, Marder VJ, Barlow GH. Plasmin degradation of crosslinked fibrin. J Clin Invest 1980; 66: 1033-43.
    CrossrefPubMedGoogle Scholar
  • 5 Bounameaux H, Cirafici P, de Moerloose P, Schneider P-A, Slosman D, Reber G, Unger P-F. Measurement of D-dimer in plasma as diagnostic aid in suspected pulmonary embolism. Lancet 1991; 337: 196-200.
    CrossrefPubMedGoogle Scholar
  • 6 Becker DM, Philbrick JT, Bachhuber TL, Humphries JE. D-dimer testing and acute venous thromboembolism. A shortcut to accurate diagnosis?. Arch Intern Med 1996; 156: 939-46.
    PubMedGoogle Scholar
  • 7 Ginsberg JS, Brill-Edwards PA, Demers C, Donovan D, Panju A. D-dimer in clinically suspected pulmonary embolism. Chest 1993; 104: 1679-84.
    CrossrefPubMedGoogle Scholar
  • 8 van Beek EJ, 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
  • 9 de Moerloose P, Minazio P, Reber G, Perrier A, Bounameaux H. D-dimer determination to exclude pulmonary embolism: a two-step approach using latex assay as a screening tool. Thromb Haemost 1994; 72: 89-91.
    PubMedGoogle Scholar
  • 10 Reber G, Vissac AM, de Moerloose P, Bounameaux H, Amiral J. A new, semiquantitative and individual ELISA for rapid measurement of plasma D-dimer in patients suspected of pulmonary embolism. Blood Coagul Fibrinolysis 1995; 06: 460-3.
    CrossrefPubMedGoogle Scholar
  • 11 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
  • 12 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
  • 13 Oger E, Leroyer C, Bressollette L, Nonent M, Le Moigne E, Bizais Y, Amiral J, Grimaux M, Clavier J, Ill P, Abgrall JF, Mottier D. Evaluation of a new, rapid, and quantitative D-Dimer test in patients with suspected pulmonary embolism. Am J Respir Crit Care Med 1998; 158: 65-70.
    CrossrefPubMedGoogle Scholar
  • 14 Koppert PW, Hoegee-de Nobel E, Nieuwenhuizen W. A monoclonal antibody-based enzyme immunoassay for fibrin degradation products in plasma. Thromb Haemost 1988; 59: 310-5.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 15 Lensing AWA, van Beek EJR, Demers C, Tiel-van Buul MMC, Yakemchuk V, van Dongen A, Coates G, Ginsberg JS, Hirsh J, ten Cate JW, Büller HR. Ventilation-perfusion lung scanning and the diagnosis of pulmonary embolism: improvement of observer agreement by the use of a lung segment reference chart. Thomb Haemost 1992; 68: 245-9.
    PubMedGoogle Scholar
  • 16 Hull RD, Hirsh J, Carter CJ, Raskob GE, Gill GJ, Jay RM, Leclerc JR, David M, Coates G. Diagnostic value of ventilation-perfusion long scanning in patients with suspected pulmonary embolism. Chest 1985; 88: 819-28.
    CrossrefPubMedGoogle Scholar
  • 17 Stein PD, Athanasoulis C, Alavi A, Greenspan RH, Hales CA, Saltzman HA, Vreim CE, Terrin ML, Weg JG. Complications and validity of pulmonary angiography in acute pulmonary embolism. Circulation 1992; 85: 462-8.
    CrossrefPubMedGoogle Scholar
  • 18 van Beek EJR, Reekers JA, Batchelor DA, Brandjes DP, Büller HR. Feasibility, safety and clinical utility of angiography in patients with suspected pulmonary embolism. European Radiology 1996; 06: 415-9.
    CrossrefPubMedGoogle Scholar
  • 19 Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic curve. Radiology 1982; 143: 29-36.
    CrossrefPubMedGoogle Scholar
  • 20 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: 2753-9.
    CrossrefPubMedGoogle Scholar
  • 21 Minnema MC, ten Cate H, van Beek EJR, van den Ende A, Hack CE, Brandjes DPM. Effects of heparin therapy on fibrinolysis in patients with pulmonary embolism. Thromb Haemost 1997; 77: 1164-7.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 22 Wells PS, Ginsberg JS, Anderson DR, Kearon C, Gent M, Turpie AG, Bormanis J, Weitz J, Chamberlain M, Bowie D, Barnes D, Hirsh J. Use of a clinical model for safe management of patients with suspected pulmonary embolism. Ann Intern Med 1998; 129: 997-1005.
    CrossrefPubMedGoogle Scholar
  • 23 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