title: Evaluation of advanced D-dimer assay for the exclusion of venous thromboembolism.
abstract: The performances for thromboembolic disease exclusion of a new microlatex-enhanced D-dimer immunoassay have been evaluated. Advanced D-dimer (Dade-Behring, Marburg, Germany) was tested with two automated analyzers, namely BCS and CA-1500. Precision studies yielded coefficients of variation (within-run and run-to-run) of 3% and 6.3% at D-dimer levels near the cut-off value, for BCS and CA-1500 respectively. Frozen samples from 294 consecutive symptomatic outpatients suspected of either deep venous thrombosis (140) or pulmonary embolism (154) from a previous management study were tested with both analyzers, as well as with the VIDAS New assay (BioMerieux, Marcy-l'Etoile, France). For BCS, sensitivity and specificity were 96.6% (95% CI, 90.5, 99.3) and 42% (35.1, 49.0) respectively at a cut-off value of 1.35 microg/ml. For CA-1500, the corresponding figures were 95.5% (88.9, 98.8) and 47.8% (40.8, 54.9) at a cutt-off value of 1.1 microg/ml. This assay appears promising and should be validated in clinical practise to assess its place in the work-up schemes of thromboembolism.
authors.affiliation: Division of Angiology and Haemostasis, Geneva University Hospital, Geneva 14, Switzerland. guido.reber@hcuge.ch
authors.forename: Guido
authors.initials: G
authors.lastname: Reber
authors.forename: Henri
authors.initials: H
authors.lastname: Bounameaux
authors.forename: Arnaud
authors.initials: A
authors.lastname: Perrier
authors.forename: Philippe
authors.initials: P
authors.lastname: de Moerloose
mesh_terms: D002138:Calibration; D003937:Diagnosis, Differential; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000592:standards*; D007841:Latex Fixation Tests; D011655:Pulmonary Embolism / Q000175:diagnosis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D020246:Venous Thrombosis / Q000175:diagnosis*
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D