title: Evaluation of a new rapid D-dimer assay for clinically suspected deep venous thrombosis (Liatest D-dimer).
abstract: In previous studies, enzyme-linked immunosorbent assays (ELISA) for plasma D-dimer analysis have demonstrated high sensitivity, suggesting their potential usefulness in excluding deep venous thrombosis (DVT). We evaluated the usefulness of a new D-dimer test (Liatest D-dimer) for suspected DVT in a prospective study of patients admitted to the hospital because of recent (not exceeding 1 week before admission) clinical signs. Contrast venography or compression ultrasonography or both were performed within 24 hours of admission. A new quantitative determination of D-dimer concentration using a suspension of microlatex particles coated with specific antibodies was tested. A standard plasma D-dimer ELISA measurement was also performed. Of 464 patients, 276 had a proven DVT (distal, 74; proximal, 202). For a cutoff level of 400 ng/mL, sensitivity of the Liatest method in the diagnosis of overall DVT was 94.6% (95% confidence interval, 92.0%-97.0%), and the specificity was 35% (95% confidence interval, 28%-42%). The sensitivity and negative predictive value were 98.5% and 95.6%, respectively, in the diagnosis of proximal DVT, but only 83.8% and 84.6%, respectively, in the diagnosis of distal DVT. This new rapid Liatest D-dimer assay seems to be highly sensitive and could replace the ELISA method in excluding patients with proximal DVT. Both methods provide lower sensitivity for distal DVT.
authors.affiliation: Department of Haematology, Hôpital de la Cavale Blanche, Brest, France.
authors.forename: M
authors.initials: M
authors.lastname: Escoffre-Barbe
authors.forename: E
authors.initials: E
authors.lastname: Oger
authors.forename: C
authors.initials: C
authors.lastname: Leroyer
authors.forename: M
authors.initials: M
authors.lastname: Grimaux
authors.forename: E
authors.initials: E
authors.lastname: Le Moigne
authors.forename: M
authors.initials: M
authors.lastname: Nonent
authors.forename: L
authors.initials: L
authors.lastname: Bressollette
authors.forename: J F
authors.initials: JF
authors.lastname: Abgrall
authors.forename: C
authors.initials: C
authors.lastname: Soria
authors.forename: J
authors.initials: J
authors.lastname: Amiral
authors.forename: P
authors.initials: P
authors.lastname: Ill
authors.forename: J
authors.initials: J
authors.lastname: Clavier
authors.forename: D
authors.initials: D
authors.lastname: Mottier
mesh_terms: D001322:Autoanalysis; D004797:Enzyme-Linked Immunosorbent Assay; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007840:Latex; D008863:Microspheres; D010690:Phlebography; D011446:Prospective Studies; D012372:ROC Curve; D012680:Sensitivity and Specificity; D013924:Thrombophlebitis / Q000175:diagnosis*; D014463:Ultrasonography
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; D007840:Latex; C036309:fibrin fragment D