Summary
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.
Key words
Soluble fibrin - pulmonary embolism - diagnosis