Use of a new monoclonal antibody-based enzyme immunoassay for soluble fibrin to exclude pulmonary embolism. ANTELOPE-Study Group.
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.
Mac Gillavry
M R
MR
Department of Internal Medicine, Slotervaart Hospital, Amsterdam, The Netherlands. igmma@slz.nl
Sanson
B J
BJ
de Monyé
W
W
Lijmer
J G
JG
Huisman
M V
MV
Büller
H R
HR
Nieuwenhuizen
W
W
Brandjes
D P
DP
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal; D015331:Cohort Studies; D003951:Diagnostic Errors; D005260:Female; D005337:Fibrin / Q000378:metabolism*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods / Q000592:standards*; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000175:diagnosis* / Q000378:metabolism; D012372:ROC Curve; D012680:Sensitivity and Specificity; D012995:Solubility
D000911:Antibodies, Monoclonal; D005337:Fibrin