Use of a New Monoclonal Antibody-Based Enzyme Immunoassay for Soluble Fibrin to Exclude Pulmonary Embolism

Melvin R. Mac Gillavry; Bernd-Jan Sanson; Wouter de Monyé; Jeroen G. Lijmer; Menno V. Huisman; Harry R. Büller; Willem Nieuwenhuizen; Dees P. M. Brandjes; the ANTELOPE-Study Group; on behalf of

doi:10.1055/s-0037-1614047

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2000; 84(03): 474-477
DOI: 10.1055/s-0037-1614047

Commentary

Schattauer GmbH

Use of a New Monoclonal Antibody-Based Enzyme Immunoassay for Soluble Fibrin to Exclude Pulmonary Embolism

Authors

Melvin R. Mac Gillavry

¹From the Department of Internal Medicine, Slotervaart Hospital, Amsterdam, The Netherlands
Bernd-Jan Sanson

²Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands
Wouter de Monyé

³Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands

⁵Department of General Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
Jeroen G. Lijmer

⁴Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, Amsterdam, The Netherlands
Menno V. Huisman

⁵Department of General Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
Harry R. Büller

²Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands
Willem Nieuwenhuizen

⁶Gaubius Laboratory, TNO Prevention and Health, Leiden, The Netherlands
Dees P. M. Brandjes

¹From the Department of Internal Medicine, Slotervaart Hospital, Amsterdam, The Netherlands

²Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands

the ANTELOPE-Study Group

Abstract

Summary

We prospectively evaluated the diagnostic performance of a new soluble fibrin assay in 303 consecutive patients with suspected pulmonary embolism and examined potentially useful cut-off levels at which this disease can be safely excluded. In addition, the diagnostic accuracy was calculated in the subgroups of in- and outpatients. The ROC curve of the assay in the total study cohort had an area under the curve of 0.69. The cut-off level associated with a sensitivity and negative predictive value of 100% was 20 ng/ml, but the specificity was only 4%. The cut-off level with a sensitivity of 90% was 30 ng/ml, which corresponded with a specificity and negative predictive value of 27% and 86%, respectively. The diagnostic performance was comparable in the subgroups of in- and outpatients. We conclude that the soluble fibrin assay has a low diagnostic accuracy and seems unsuitable as a screening test for the exclusion of pulmonary embolism.

Key words

Soluble fibrin - pulmonary embolism - diagnosis

Full Text

References

References
1 Doolittle RF. Fibrinogen and fibrin. Sci Am 1981; 245: 92-101.
2 Sasaki T, Page IH, Shainoff JR. Soluble complexes of fibrinogen and fibrin. Science 1966; 152: 1069-71.
3 Alkajersig N, Fletcher AP. Formation of soluble fibrin oligomers in purified system and in plasma. Biochem J 1983; 213: 75-83.
4 Demers C, Ginsberg JS, Johnston M, Brill-Edwards P, Panju P. D-dimer and thrombin-antithrombin III complexes in patients with clinically suspected pulmonary embolism. Thromb Haemost 1992; 67: 408-12.
5 Ginsberg JS, Siragusa S, Douketis J, Johnston M, Moffat K, Donovan D, McGinnis J, Brill-Edwards P, Panju A, Patel A, Weitz JI. Evaluation of a soluble fibrin assay in patients with suspected pulmonary embolism. Thromb Haemost 1996; 75: 551-4.
6 Reber G, Bounameaux H, Perrier A, de Moerloose Ph. Performances of the fibrin monomer test for the exclusion of pulmonary embolism in symptomatic outpatients. Thromb Haemost 1999; 81: 221-3.
7 Bos R, Laterveer-Vreeswijk GH, Lockwood D, Szewczyk K, Nieuwenhuizen W. A new enzyme immunoassay for soluble fibrin in plasma, with a high discriminating power for thrombotic disorders. Thromb Haemost 1999; 81: 54-9.
8 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.
9 Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristics curve. Radiology 1982; 143: 29-36.
10 Takahashi H, Wada K, Hanano M, Niwano H, Takizawa S, Yazawa Y, Shibata A. Fibrinolysis and fibrinogenolysis in patients with thrombotic disease. Blood Coagul Fibrinolysis 1992; 03: 193-6.
11 Dempfle C-E. The use of soluble fibrin in evaluating the acute and hypercoagulable state. Thromb Haemost 1999; 82: 673-83.