Use of a new monoclonal antibody-based enzyme immunoassay for soluble fibrin to exclude pulmonary embolism. ANTELOPE-Study Group.

Abstract

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 pulmonary embolism.

• Authors: M R Mac Gillavry, B J Sanson, W de Monyé, J G Lijmer, M V Huisman, H R Büller, W Nieuwenhuizen, D P Brandjes
• Journal: Thrombosis and haemostasis (Thromb Haemost) Vol. 84 Issue 3 Pg. 474-7 (Sep 2000) ISSN: 0340-6245 [Print] Germany
• PMID: 11019974 (Publication Type: Evaluation Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Fibrin

Topics

• Adult
• Aged
• Antibodies, Monoclonal
• Cohort Studies
• Diagnostic Errors
• Female
• Fibrin (metabolism)
• Humans
• Immunoenzyme Techniques (methods, standards)
• Male
• Middle Aged
• Predictive Value of Tests
• Prospective Studies
• Pulmonary Embolism (diagnosis, metabolism)
• ROC Curve
• Sensitivity and Specificity
• Solubility