title: Contribution of a new, rapid, individual and quantitative automated D-dimer ELISA to exclude pulmonary embolism.
abstract: The performance of a new automated ELISA for a rapid, individual and quantitative measurement of plasma D-dimer (VIDAS D-dimer) has been evaluated. First, a study of 100 patients was performed in order to choose the best couple of antibodies in comparison with an already clinically validated ELISA. Then the results were certified in a prospective study including 195 consecutive patients suspected of pulmonary embolism (PE). For a cut-off level of 500 ng/ml VIDAS D-dimer showed a sensitivity of 100% (95% confidence interval 92-100), a specificity of 37.6%, a negative predictive value of 100% (95% CI 93.3-100) and a positive predictive value of 33.1%. During a 6 months' follow-up no patient (95% CI 0-6.4) with D-dimer < 500 ng/ml presented a new suspicion of venous thromboembolic disease. These results suggest that this rapid and single-dose ELISA provides a very useful tool for the clinician to exclude on a day-to-day basis the diagnosis of PE.
authors.affiliation: Division of Angiology and Haemostasis, University Hospital of Geneva, Switzerland.
authors.forename: P
authors.initials: P
authors.lastname: de Moerloose
authors.forename: S
authors.initials: S
authors.lastname: Desmarais
authors.forename: H
authors.initials: H
authors.lastname: Bounameaux
authors.forename: G
authors.initials: G
authors.lastname: Reber
authors.forename: A
authors.initials: A
authors.lastname: Perrier
authors.forename: G
authors.initials: G
authors.lastname: Dupuy
authors.forename: J L
authors.initials: JL
authors.lastname: Pittet
mesh_terms: D001322:Autoanalysis; D002138:Calibration; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D016014:Linear Models; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000097:blood* / Q000175:diagnosis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D