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Title

A multicenter evaluation of a new quantitative highly sensitive D-dimer assay for exclusion of venous thromboembolism
Authors
De Moerloose, Philippe
Palareti, Gualtiero
Aguilar, Carlos
Legnani, Cristina
Reber, Guido
Peetz, Dirk
Published in Thrombosis and haemostasis. 2008, vol. 100, no. 3, p. 505-12
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
Identifiers
PMID: 18766269
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Structures
Faculté de médecine / Section de médecine clinique / Département de médecine
Research group Anticorps antiphospholipides (12)
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. 505-12. doi: 10.1160/TH08-04-0202 https://archive-ouverte.unige.ch/unige:1922

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Deposited on : 2009-06-09

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