Clinical evaluation of a monoclonal antibody-based enzyme immunoassay for fibrin degradation products in patients with clinically suspected pulmonary embolism. ANTELOPE-Study Group.
We prospectively evaluated the diagnostic accuracy of the Fibrinostika FbDP assay in 304 consecutive patients with suspected pulmonary embolism and examined potentially useful cut-off points at which the disease can be excluded. The prevalence of pulmonary embolism was 31%. The assay generated an area under the Receiver Operating Characteristic curve of 0.79 (95% CI 0.73-0.84). A cut-off point of 0.05 microg/ml yielded a sensitivity, specificity, negative predictive value and an exclusion efficiency of 100% (95% CI 96-100), 5% (95% CI 2-9), 100% (95% CI 69-100) and 3% (95% CI 2-6), respectively. A clinically useful cut-off point seems to be 0.11 microg/ml which corresponded with a sensitivity, specificity, negative predictive value and an exclusion efficiency of 96% (95% CI 90-99), 27% (95% CI 24-28), 93% (95% CI 84-98) and 20% (95% CI 16-25), respectively. We conclude that the assay has potential clinical utility for the exclusion of pulmonary embolism, but it cannot be used as a sole test.
Mac Gillavry
M R
MR
Department of Internal Medicine, Slotervaart Hospital, Amsterdam, The Netherlands. igmma@slz.nl
de Monyé
W
W
Lijmer
J G
JG
Nieuwenhuizen
W
W
Büller
H R
HR
Huisman
M V
MV
Brandjes
D P
DP
D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005338:Fibrin Fibrinogen Degradation Products / Q000276:immunology / Q000378:metabolism*; D006801:Humans; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000097:blood / Q000175:diagnosis*; D012372:ROC Curve; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012680:Sensitivity and Specificity
D000911:Antibodies, Monoclonal; D005338:Fibrin Fibrinogen Degradation Products; D011933:Reagent Kits, Diagnostic