Summary
Background. The objective of this study was to determine the clinical utility of an
enzyme immunoassay (HIA) for soluble fibrin in patients with clinically suspected
deep vein thrombosis (DVT).
Methods and Results. 101 unselected patients with clinically suspected DVT underwent
blood sampling for measurement of plasma levels of soluble fibrin, and objective testing
for DVT. According to results of the objective tests, patients were classified as
DVT-positive (n = 34) or DVT-negative (n = 67). Using different cut-points of soluble
fibrin results, the sensitivities, specificities, positive and negative predictive
values of the soluble fibrin assay were calculated. A soluble fibrin result of ≤0.75
mg/ml showed a sensitivity and negative predictive value of 100%, and a specificity
of 17.9% for DVT, a soluble fibrin result of ≤ 1.40 mg/ml showed a sensitivity of
91.2% and a negative predictive value of 93.6%, and a specificity of 65.7% for DVT,
whereas a soluble fibrin result of ≤ 8.0 mg/ml showed a specificity and positive predicive
value of 100% for DVT.
Conclusions. This study demonstrates that the soluble fibrin assay used in the study
has potential clinical utility as a diagnostic test in patients with clinically suspected
DVT and supports further evaluation of this assay.
