Application of a Novel and Rapid Whole Blood Assay for D-Dimer in Patients with Clinically Suspected Pulmonary Embolism

Jeffrey S Ginsberg; Philip S Wells; Patrick Brill-Edwards; Dianne Donovan; Akbar Panju; Edwin J R van Beek; Ameen Patel

doi:10.1055/s-0038-1653722

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 1995; 73(01): 035-038
DOI: 10.1055/s-0038-1653722

Original Article

Clinical Studies

Schattauer GmbH Stuttgart

Application of a Novel and Rapid Whole Blood Assay for D-Dimer in Patients with Clinically Suspected Pulmonary Embolism

Authors

Jeffrey S Ginsberg

¹The Department of Medicine, McMaster University, Hamilton, Canada
Philip S Wells

¹The Department of Medicine, McMaster University, Hamilton, Canada
Patrick Brill-Edwards

¹The Department of Medicine, McMaster University, Hamilton, Canada
Dianne Donovan

¹The Department of Medicine, McMaster University, Hamilton, Canada
Akbar Panju

¹The Department of Medicine, McMaster University, Hamilton, Canada
Edwin J R van Beek

²The Centre for Hemostasis, Thrombosis, Atherosclerosis and Inflammation Research, Academic Medical Centre, Amsterdam, The Netherlands
Ameen Patel

¹The Department of Medicine, McMaster University, Hamilton, Canada

Abstract

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Summary

Study Objective: To determine the clinical utility of a novel whole blood assay for D-dimer (SimpliRED™) in patients with clinically suspected pulmonary embolism (PE).

Design: Prospective cohort.

Patients: Eighty-six consecutive patients with clinically suspected PE.

Intervention: All patients had the SimpliRED D-dimer assay performed and underwent ventilation/perfusion (V/Q) lung scanning and bilateral impedance plethysmography (IPG); pulmonary angiography was performed in two patients. Patients were classified as: 1) PE-positive; positive pulmonary angiography or high probability V/Q scan or non-high probability V/Q scan and either abnormal IPG (either at presentation or upon serial testing and confirmed by contrast venography) or symptomatic thromboembolic event within three months of presentation or 2) PE-negative; normal V/Q scan or normal pulmonary angiography or non-high probability V/Q scan and normal serial IPG and absence of symptomatic venous thromboembolism within three months of follow up. Sixteen (19%) patients were classified as PE-positive and 70 (81%) patients were classified as PE-negative.

Measurements and Result: The sensitivities, specificities, positive predictive values, and negative predictive values of the D-dimer assay were calculated for all patients and for the subgroup of patients without comorbid conditions that independently can cause elevated D-dimer levels. The D-dimer showed a sensitivity of 94%, a negative predictive value of 98%, a specificity of 66%, and a positive predictive value of 38%. In the subgroup of patients without comorbid conditions, the specificity increased to 98% and the positive predictive value to 83%, but because only six patients had an abnormal D-dimer level, the 95% confidence interval on the observed positive predictive value is wide (36-100%).

Conclusions: This study demonstrates that the SimpliRED D-dimer assay, which can be performed and interpreted at the bedside within five minutes, has potential clinical utility as an exclusionary test in patients with clinically suspected PE. The assay should be evaluated in large clinical management studies.

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Referenzen

References
1 Hull RD, Raskob GE, Carter CJ, Coates G, Gill GJ, Sackett DL, Hirsh J, Thompson M. Pulmonary embolism in outpatients with pleuritic chest pain. Arch Intern Med 1988; 148: 838-844
2 Bell WR, Simon TL, DeMets DL. The clinical features of submassive and massive pulmonary embolism. Am J Med 1977; 62: 355-360
3 Hull RD, Hirsh J, Carter CJ, Jay RM, Dodd PE, Ockelford PA, Coates G, Gill GJ, Turpie AG, Doyle DJ, Biiller HR, Raskob GE. Pulmonary angiography, ventilation lung scanning and venography for clinically suspected pulmonary embolism with abnormal perfusion lung scan. Ann Intern Med 1983; 98: 891-899
4 Hull RD, Hirsh J, Carter CJ, Raskob GE, Gill GJ, Leclerc JR, David M, Coates G. Diagnostic value of ventilation-perfusion lung scanning in patients with suspected pulmonary embolism. Chest 1985; 88: 819-828
5 The PIOPED Investigators. Value of the ventilation/perfusion scan in acute pulmonary embolism. JAMA 1990; 263: 2753-2759
6 Kelley MA, Carson JL, Palevsky HI, Schwartz JS. Diagnosing pulmonary embolism: new facts and strategies. Ann Intern Med 1991; 114: 300-306
7 Hull RD, Raskob G, Ginsberg JS, Panju AA, Brill-Edwards P, Coates G, Pineo GF. A noninvasive strategy for the treatment of patients with suspected pulmonary embolism. Arch Int Med 1994; 154: 289-297
8 Bounameaux H, Slaosman D, de Moerloose P, Reber G. Laboratory diagnosis of pulmonary embolism: value of increased levels of plasma D–dimer and thrombin-antithrombin III complexes. Biomed & Pharmacother 1989; 43: 385-388
9 Bridey F, Philipotteau C, Dreyfus M, Simonneau G. Plasma D-Dimer and pulmonary embolism. Lancet 1989; 1: 791-792
10 Speiser W, Leitha T, Dudczak R, Lechner K. Letter to the editor. Lancet 1989; 1: 792
11 Goldhaber SZ, Vaughan DE, Tumeh SS, Loscalzo J. Utility of cross-linked fibrin degradation products in the diagnosis of pulmonary embolism. Am Heart J 1988; 116: 505-508
12 Bounameaux H, Cirafici P, de Moerloose P, Schneider PA, Slosman D, Reber G, Unger PF. Measurement of D-dimer as diagnostic aid in suspected pulmonary embolism. Lancet 1991; 337: 196-200
13 Pelzer H, Schwarz A, Heimburger N. Determination of human thrombinantithrombin III complex in plasma with an enzyme-linked immunosorbent assay. Thromb Haemost 1988; 59: 101-106
14 Rowbotham BJ, Carrol P, Whitaker AN, Bunce IH, Cobcroft RG, Elms MJ, Masci PP, Bundesen PG, Rylatt DB, Webber AJ. Measurement of crosslinked fibrin derivates – use in the diagnostic of venous thrombosis. Thromb Haemost 1987; 57: 59-61
15 Bounameaux H, Schneider PA, Reber G, de Moerloose P, Krahenbuhl B. Measurement of plasma D-Dimer for diagnosis of deep venous thrombosis. Am J Clin Pathol 1989; 91: 82-85
16 Bounameaux H, Cirafici P, de Moerloose P, Schneider PA, Slosman D, Reber G, Unger PF. Measurement of D-dimer in plasma as diagostic aid in suspected pulmonary embolism. Lancet 1991; 337: 196-200
17 Demers C, Ginsberg JS, Johnston M, Brill-Edwards P, Panju A. D-dimer and thrombin-antithrombin III complexes in patients with clinically suspected pulmonary embolism. Thromb Haemost 1992; 67: 408-412
18 Heaton DC, Billings JD, Hickton CM. Assessment of D-dimer assays for the diagnosis of deep venous thrombosis. J Lab Clin Med 1987; 110: 588-91
19 Ginsberg JS, Brill-Edwards P, Demers C, Donovan D, Panju A. D-dimer in patients with clinically suspected pulmonary embolism. Chest 1993; 104: 1679-1684
20 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
21 Brenner B, Pery M, Lanir N, Jabbarin A, Kraftori JK, Gaitini D, Rylatt D. Application of SimpliRED D-dimer in the diagnosis of deep vein thrombosis. Thromb Haemost 1993; 69: 832 (1042 abs)
22 Shaukat N, Rowlands DJ, Cotter L, Walker MG, Douglas JT. The specificity and sensitivity of various Elisa methods for fibrin degradation products in the diagnosis of arterial and venous thrombosis. Thromb Haemost 1993; 69: 839
23 Wells PS, Stevens P, Massicotte P, Ginsberg JS. A rapid D-dimer assay with high sensitivity and negative predictive value in patients with suspected deep vein thrombosis. Blood 1993; 82: 407a
24 John MA, Elms MJ, O'Reilly EJ, Rylatt DB, Bundesen PG, Hillyard CJ. The simpliRED D-dimer test: a novel assay for the detection of cross-linked fibrin degradation products in whole blood. Thromb Res 1990; 58: 273-281
25 Hull R, Van Aken WG, Hirsh J, Gallus AS, Hoicka G, Turpie AG G, Walker I, Gent M. Impedance plethysmography using the occlusive cuff technique in the diagnosis of venous thrombosis. Circulation 1976; 53: 696-700