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Thromb Haemost 1999; 81(01): 50-53
DOI: 10.1055/s-0037-1614417
DOI: 10.1055/s-0037-1614417
Review Article
Performance of a New Fibrin Monomer Assay to Exclude Deep Vein Thrombosis in Symptomatic Outpatients
Further Information
Summary
In this study we prospectively assessed the reliability of a new fibrin monomer assay in 106 outpatients with clinically suspected deep venous thrombosis of the lower limb. According to the results of the objective tests and using different cut-off points we calculated the sensitivity, specificity and negative predictive value of the fibrin monomer assay. The prevalence of deep vein thrombosis was 44.3% (31.1% proximal, 13.2% distal). Using a cut-off level of plasma fibrin monomer of 3.5 μg/ml, a sensitivity, specificity and negative predictive value of 100% (95% CI: 94-100%), 35.6% (95% CI: 23-48%) and 100% (95% CI: 86-100%), respectively, were obtained. The exclusion rate was 19.8% (95% CI: 12-27%) of all referred patients. These accuracy indices compared favourably with the respective results of a routine D-dimer ELISA used for comparison. Conclusion: This new fibrin monomer assay appears to be a reliable method for the exclusion of deep vein thrombosis in symptomatic outpatients.
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References
- 1 Lensing AWA, Hirsh J, Büller HR. Diagnosis of venous thrombosis. In: Haemostasis and Thrombosis, basic principles and clinical practice. Colman RW, Hirsh J, Marder VJ, Salzman EW. (eds). 3rd edition. Philadelphia: JP Lippincott; 1994: pp 1297-321.
- 2 Wells PS, Hirsh J, Anderson DR, Lensing AWA, Foster G, Kearon C, Weitz J, D'Ovidio R, Cogo A, Prandoni P, Girolami A, Ginsberg JS. Accuracy of clinical assessment of deep-vein thrombosis. Lancet 1995; 345: 1326-30.
- 3 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.
- 4 Ginsberg JS. Management of venous thromboembolism. N Engl J Med 1996; 335: 1816-28.
- 5 Becker DM, Philbrick JT, Bachhuber TL, Humphries JE. D-Dimer testing and acute thromboembolism. Arch Intern Med 1996; 156: 939-46.
- 6 Turkstra F, van Beek JR E, ten Cate JW, Büller HR. Reliable rapid blood test for the exclusion of venous thromboembolism in symptomatic outpatients. Thromb Haemost 1996; 76: 9-11.
- 7 Ginsberg JS, Siragusa S, Douketis J, Johnston M, Moffat K, Stevens P, Brill-Edwards P, Panju A, Patel A. Evaluation of a soluble fibrin assay in patients with suspected deep vein thrombosis. Thromb Haemost 1995; 74: 833-6.
- 8 Nieuwenhuizen W. Soluble fibrin as a molecular marker for a pre-thrombotic state: a mini review. Blood Coag Fibrinol 1993; 4: 93-6.
- 9 Okajima K, Uchiba M, Murakami K, Okabe H, Takatsuki K. Determination of plasma soluble fibrin using a new ELISA method in patients with disseminated intravascular coagulation. Am J Hematol 1996; 51: 186-91.
- 10 Wada H, Wakita Y, Nakase T, Shimura M, Hiyoyama K, Nagaya S, Degu-chi H, Mori Y, Kaneko T, Deguchi K, Fujii J, Shiku H. Increased plasma soluble fibrin monomer levels in patients with disseminated intravascular coagulation. Am J Hematol 1996; 51: 255-60.
- 11 Lill H, Spannagl A, Trauner A, Schramm W, Schuller D, Ofenloch-Haehnle B, Draeger B, Naser W, Dessauer A. A new immunoassy for soluble fibrin enables a more sensitive detection of the activation state of blood coagulation in vivo. Blood Coag Fibrinol 1993; 4: 97-102.
- 12 Wiman B, Ranby M. Determination of soluble fibrin in plasma by a rapid and quantitative spectrophotometric assay. Thromb Haemost 1986; 55: 189-93.
- 13 Dempfle CE, Pfitzner SA, Dolmann M, Huck K, Stehle G, Heene DL. Comparison of immunological and functional assays for measurement of soluble fibrin. Thromb Haemost 1995; 74: 673-9.
- 14 Rahr HB, Danielsen D, Andersen BS, Borris LC, Lassen MR. Poor correlation between soluble fibrin concentrations measured by two commercially available immunoassays. Thromb Res 1996; 81: 607-14.
- 15 ScheeferS-Borchel U, Müller-Berghaus G, Fuhge P, Eberle R, Heimburger N. Discrimination between fibrin and fibrinogen by a monoclonal antibody against a synthetic peptide. Proc. Natl. Acad. Sci. USA 1985; 82: 7091-5.
- 16 Schielen WJG, Voskuilen M, Tesser I G, Nieuwenhuizen W. The sequence A-α-(148-160) in fibrin, but not in fibrinogen, is accessible to monoclonal antibodies. Proc. Natl. Acad. Sci. USA 1989; 86: 8951-4.
- 17 Schielen WJG, Adams HPHM, van Leuven K, Voskuilen M, Tesser GJ, Nieuwenhuizen W. The sequence gamma-(312-324) is a fibrin specific epitope. Blood 1991; 77: 2169-73.
- 18 Dempfle CE, Dollman M, Lill H, Puzzovio D, Dessauer A, Heene DL. Binding of a new monoclonal antibody against N-terminal heptapeptide of fibrin α chains to fibrin polymerization site “A”: effects of fibrinogen and fibrinogen derivatives, and pretreatment of samples with NaSCN. Blood Coag Fibrinol 1992; 4: 79-86.
- 19 Baumgartner I, Braunschweig M, Triller J, Mahler F. Power-based colour coded duplex sonography for evaluation of calf veins. Int Angiol 1998; 17: 43-8.
- 20 Bounameaux H, Cirafici P, de Moerloose P, Schneider P-A, Slosman D, Reber G, Unger PF. Measurement of D-dimer in plasma as diagnostic aid in suspected pulmonary embolism. Lancet 1991; 337: 196-200.
- 21 Vogel G, Dempfle CE, Spannagl M, Leskopf W. The value of quantitative fibrin monomer determination in the early diagnosis of postoperative deep vein thrombosis. Thromb Res 1996; 81: 241-51.
- 22 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.
Correspondence to:
Dr. W. A. Wuillemin
Central Hematology Laboratory
University Hospital, Inselspital
CH-3010 Bern, Switzerland
Phone: 0041316329412
Fax: 0041316323406
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References
- 1 Lensing AWA, Hirsh J, Büller HR. Diagnosis of venous thrombosis. In: Haemostasis and Thrombosis, basic principles and clinical practice. Colman RW, Hirsh J, Marder VJ, Salzman EW. (eds). 3rd edition. Philadelphia: JP Lippincott; 1994: pp 1297-321.
- 2 Wells PS, Hirsh J, Anderson DR, Lensing AWA, Foster G, Kearon C, Weitz J, D'Ovidio R, Cogo A, Prandoni P, Girolami A, Ginsberg JS. Accuracy of clinical assessment of deep-vein thrombosis. Lancet 1995; 345: 1326-30.
- 3 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.
- 4 Ginsberg JS. Management of venous thromboembolism. N Engl J Med 1996; 335: 1816-28.
- 5 Becker DM, Philbrick JT, Bachhuber TL, Humphries JE. D-Dimer testing and acute thromboembolism. Arch Intern Med 1996; 156: 939-46.
- 6 Turkstra F, van Beek JR E, ten Cate JW, Büller HR. Reliable rapid blood test for the exclusion of venous thromboembolism in symptomatic outpatients. Thromb Haemost 1996; 76: 9-11.
- 7 Ginsberg JS, Siragusa S, Douketis J, Johnston M, Moffat K, Stevens P, Brill-Edwards P, Panju A, Patel A. Evaluation of a soluble fibrin assay in patients with suspected deep vein thrombosis. Thromb Haemost 1995; 74: 833-6.
- 8 Nieuwenhuizen W. Soluble fibrin as a molecular marker for a pre-thrombotic state: a mini review. Blood Coag Fibrinol 1993; 4: 93-6.
- 9 Okajima K, Uchiba M, Murakami K, Okabe H, Takatsuki K. Determination of plasma soluble fibrin using a new ELISA method in patients with disseminated intravascular coagulation. Am J Hematol 1996; 51: 186-91.
- 10 Wada H, Wakita Y, Nakase T, Shimura M, Hiyoyama K, Nagaya S, Degu-chi H, Mori Y, Kaneko T, Deguchi K, Fujii J, Shiku H. Increased plasma soluble fibrin monomer levels in patients with disseminated intravascular coagulation. Am J Hematol 1996; 51: 255-60.
- 11 Lill H, Spannagl A, Trauner A, Schramm W, Schuller D, Ofenloch-Haehnle B, Draeger B, Naser W, Dessauer A. A new immunoassy for soluble fibrin enables a more sensitive detection of the activation state of blood coagulation in vivo. Blood Coag Fibrinol 1993; 4: 97-102.
- 12 Wiman B, Ranby M. Determination of soluble fibrin in plasma by a rapid and quantitative spectrophotometric assay. Thromb Haemost 1986; 55: 189-93.
- 13 Dempfle CE, Pfitzner SA, Dolmann M, Huck K, Stehle G, Heene DL. Comparison of immunological and functional assays for measurement of soluble fibrin. Thromb Haemost 1995; 74: 673-9.
- 14 Rahr HB, Danielsen D, Andersen BS, Borris LC, Lassen MR. Poor correlation between soluble fibrin concentrations measured by two commercially available immunoassays. Thromb Res 1996; 81: 607-14.
- 15 ScheeferS-Borchel U, Müller-Berghaus G, Fuhge P, Eberle R, Heimburger N. Discrimination between fibrin and fibrinogen by a monoclonal antibody against a synthetic peptide. Proc. Natl. Acad. Sci. USA 1985; 82: 7091-5.
- 16 Schielen WJG, Voskuilen M, Tesser I G, Nieuwenhuizen W. The sequence A-α-(148-160) in fibrin, but not in fibrinogen, is accessible to monoclonal antibodies. Proc. Natl. Acad. Sci. USA 1989; 86: 8951-4.
- 17 Schielen WJG, Adams HPHM, van Leuven K, Voskuilen M, Tesser GJ, Nieuwenhuizen W. The sequence gamma-(312-324) is a fibrin specific epitope. Blood 1991; 77: 2169-73.
- 18 Dempfle CE, Dollman M, Lill H, Puzzovio D, Dessauer A, Heene DL. Binding of a new monoclonal antibody against N-terminal heptapeptide of fibrin α chains to fibrin polymerization site “A”: effects of fibrinogen and fibrinogen derivatives, and pretreatment of samples with NaSCN. Blood Coag Fibrinol 1992; 4: 79-86.
- 19 Baumgartner I, Braunschweig M, Triller J, Mahler F. Power-based colour coded duplex sonography for evaluation of calf veins. Int Angiol 1998; 17: 43-8.
- 20 Bounameaux H, Cirafici P, de Moerloose P, Schneider P-A, Slosman D, Reber G, Unger PF. Measurement of D-dimer in plasma as diagnostic aid in suspected pulmonary embolism. Lancet 1991; 337: 196-200.
- 21 Vogel G, Dempfle CE, Spannagl M, Leskopf W. The value of quantitative fibrin monomer determination in the early diagnosis of postoperative deep vein thrombosis. Thromb Res 1996; 81: 241-51.
- 22 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.