Use of a new monoclonal antiboy-based enzyme immunoassay for soluble fibrin to exclude pulmonary embolism

M. R. Mac Gillavry*, B. J. Sanson, W. De Monye, J. G. Lijmer, M. V. Huisman, H. R. Buller, W. Nieuwenhuizen, D. P.M. Brandjes, M. H. Prins, P. M.T. Pattynama, M. J.L. Van Strijen, G. J. Kieft, M. De Rijk, P. J. Hagen, O. S. Hoekstra, P. E. Postmus, I. J.C. Hartmann, J. D. Banga, P. F.G.M. Van Waes

*Corresponding author for this work

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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 pulmunary embolism.

Original languageEnglish
Pages (from-to)474-477
Number of pages4
JournalThrombosis and Haemostasis
Issue number3
Publication statusPublished - 2000

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