title: Safe Exclusion of Deep Vein Thrombosis by a Rapid Sensitive ELISA D-dimer and Compression Ultrasonography in 1330 Outpatients With Suspected DVT.
abstract: Of 1330 outpatients with suspected deep vein thrombosis (DVT), a normal enzyme-linked immunosorbent assay (ELISA) d-dimer (VIDAS) of <500 ng/mL was true negative in 382 of 384 and false negative in compression ultrasonography (CUS) in 2, indicating a sensitivity of 99.52% and a negative predictive value (NPV) of 99.48%, with a specificity of 36% irrespective of clinical score. In 1059 outpatients with no DVT, the CUS was positive for the alternative diagnoses (AD): Bakers cyst, muscle hematoma, or old DVT in 62 (5.8%); superficial vein thrombosis without DVT in 78 (7.4%), and leg edema or varices in 17%. A second CUS in 641 patients was positive in 26 (4.0%), indicating an NPV of 96% after a first negative CUS. The NPV of the combination of a negative first CUS and a ELISA d-dimer test <1000 ng/mL was 99.1% at a specificity of 66.9%. As this strategy is cost effective by reduction in the need to repeat CUS by 67%, we designed a novel algorithm for the safe exclusion and diagnosis of DVT and AD for subsequent evaluation in a large prospective study.
authors.affiliation: Thrombosis and Hemostasis Research, Department of Hematology, University Hospital Antwerp, Antwerp, Belgium Belgium STAR-Medical Diagnostic Center, Primary Care Medicine, Rotterdam, the Netherlands Goodheart Institute& Foundation in Nature Medicine & Health, Blood Coagulation and Vascular Medicine Center, Rotterdam, the Netherlands goodheartcenter@upcmail.nl.
authors.forename: Jan Jacques
authors.initials: JJ
authors.lastname: Michiels
authors.affiliation: Belgium STAR-Medical Diagnostic Center, Primary Care Medicine, Rotterdam, the Netherlands.
authors.forename: Hanny
authors.initials: H
authors.lastname: Maasland
authors.affiliation: Belgium STAR-Medical Diagnostic Center, Primary Care Medicine, Rotterdam, the Netherlands.
authors.forename: Wim
authors.initials: W
authors.lastname: Moossdorff
authors.affiliation: Belgium STAR-Medical Diagnostic Center, Primary Care Medicine, Rotterdam, the Netherlands.
authors.forename: Mildred
authors.initials: M
authors.lastname: Lao
authors.affiliation: Thrombosis and Hemostasis Research, Department of Hematology, University Hospital Antwerp, Antwerp, Belgium.
authors.forename: Alain
authors.initials: A
authors.lastname: Gadiseur
authors.affiliation: Thrombosis and Hemostasis Research, Department of Hematology, University Hospital Antwerp, Antwerp, Belgium.
authors.forename: Wilfried
authors.initials: W
authors.lastname: Schroyens
mesh_terms: D000465:Algorithms; D015415:Biomarkers / Q000097:blood; D003661:Decision Support Techniques; D003937:Diagnosis, Differential; D004797:Enzyme-Linked Immunosorbent Assay; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D010045:Outpatients; D011237:Predictive Value of Tests; D011446:Prospective Studies; D015203:Reproducibility of Results; D014463:Ultrasonography / Q000379:methods*; D020246:Venous Thrombosis / Q000097:blood* / Q000000981:diagnostic imaging* / Q000503:physiopathology
chemical_list: D015415:Biomarkers; D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D
keywords: ELISA d-dimer assay; alternative diagnosis; clinical score; compression ultrasonography; deep vein thrombosis; pretest clinical probability