en
Scientific article
English

A multicenter evaluation of a new quantitative highly sensitive D-dimer assay for exclusion of venous thromboembolism

Published inThrombosis and haemostasis, vol. 100, no. 3, p. 505-512
Publication date2008
Abstract

D-dimer testing is widely applied for exclusion of deep-vein thrombosis (DVT) and pulmonary embolism (PE). We report on a multicenter performance evaluation of a new particle-enhanced immunoassay, Innovance D-Dimer. Innovance D-Dimer assay was performed in 1,543 frozen samples from outpatients suspected of DVT and/or PE enrolled in three management studies as well as in a routine clinical practice. Samples were assayed on BCS/BCS XP, BCT as well as Sysmex CA-7000, CA-1500 and CA-560 analyzers (cut-off on all analyzers: 0.5 mg/l). Stratus CS D-Dimer and Vidas D-Dimer Exclusion were used for comparison. The precision study indicated total coefficients of variation ranging from 2.1% to 8.4% depending on the analyzer and on the sample. Sensitivity and negative predictive values were above 99% and their lower 95% confidence interval were equal or above 97.4% and 98.6%, respectively. Specificity ranged from 38.2% to 40.4% and the respective lower 95% confidence intervals from 35.5% to 37.7%. Area under the curve was 0.90 for all assay systems except for Innovance D-Dimer with BCT (0.89). Two samples from patients with distal DVT tested negative with all assay systems. One patient with high pre-test clinical probability and proximal DVT tested negative with Vidas D-Dimer Exclusion. Our data indicate that the performances of Innovance D-Dimer, regardless of the analyzer, are similar to the reference methods, and that this assay can be used for the exclusion of venous thromboembolic disease.

Keywords
  • Algorithms
  • Calibration
  • Chemistry, Clinical/methods
  • Dimerization
  • Fibrin Fibrinogen Degradation Products/analysis
  • Humans
  • Immunoassay/instrumentation/methods
  • Predictive Value of Tests
  • Probability
  • Regression Analysis
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Venous Thromboembolism/blood/diagnosis
Citation (ISO format)
DE MOERLOOSE, Philippe et al. A multicenter evaluation of a new quantitative highly sensitive D-dimer assay for exclusion of venous thromboembolism. In: Thrombosis and haemostasis, 2008, vol. 100, n° 3, p. 505–512. doi: 10.1160/TH08-04-0202
Identifiers
ISSN of the journal0340-6245
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Creation06/09/2009 12:31:00 PM
First validation06/09/2009 12:31:00 PM
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