title: A new rapid point-of-care D-dimer enzyme-linked immunosorbent assay (Stratus CS D-dimer) for the exclusion of venous thromboembolism.
abstract: To evaluate the performances of a new D-dimer assay, Stratus CS D-dimer (Dade Behring, Newark, Delaware, USA), for the exclusion of venous thromboembolism and to determine the best cut-off values. This test relies on a sandwich enzyme-linked immunosorbent assay with a fluorogenic substrate in a radial partition immunoassay system in a dedicated device. It does not require laboratory staff and the results are available within 18 min. Two hundred and ninety-one frozen samples from patients suspected of either deep venous thrombosis (n = 137) or pulmonary embolism (n = 154) were measured and the results compared with the VIDAS D-dimer New assay. There were 37 deep venous thrombosis (27%) and 49 pulmonary embolism (32%) samples. Receiver-operating characteristic curve analysis indicated that the cut-off value could be set at either 300 or 400 ng/ml Fibrinogen Equivalent Units (FEU). The coefficient of variation determined with a lyophilized low-level control plasma (305 ng/ml FEU) was 6%. With a cut-off at 300 ng/ml FEU, the sensitivity, the specificity and the negative predictive value were 100% [95% confidence interval (CI), 95.8-100], 33.1% (95% CI, 26.8-40) and 100% (95% CI, 94.7-100), respectively. Raising the cut-off to 400 ng/ml FEU, the corresponding figures were 96.5% (95% CI, 90.1-99.3), 46.3% (95% CI, 39.4-53.2) and 96.9% (95% CI, 91.3-99.4), respectively. At 400 ng/ml, three results were false-negative, one with both devices and two with the Stratus D-dimer only. Stratus D-dimer appears to be suitable for the exclusion of venous thromboembolism in the emergency room setting.
authors.affiliation: Division of Angiology and Haemostasis, Geneva University Hospital, 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: D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D020246:Venous Thrombosis / Q000097:blood*
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D