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

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

doi:10.1055/s-0037-1613939

Thrombosis and Haemostasis, Inhaltsverzeichnis

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

Authors

Melvin R. Mac Gillavry

¹From the Department of Internal Medicine, Slotervaart Hospital, Amsterdam
Wouter de Monyé

²Department of Radiology, Leiden University Medical Center, Leiden

⁶Department of General Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
Jeroen G. Lijmer

³Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, Amsterdam
Willem Nieuwenhuizen

⁴Gaubius Laboratory, TNO Prevention and Health, Leiden
Harry R. Büller

⁵Department of Vascular Medicine, Academic Medical Center, Amsterdam
Menno V. Huisman

⁶Department of General Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
Dees P. M. Brandjes

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

⁵Department of Vascular Medicine, Academic Medical Center, Amsterdam

the ANTELOPE-Study Group

Abstract

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

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Referenzen

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