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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)

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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.


 

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