Contact Person

Dr. Elinor Switzer

Managing Editor

Phone: +49 (0)711 - 8931-230
Fax: +49 (0)711 - 8931-323
send an Email


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

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
Issue: 2008: 100/3 (Sep) pp. 365-516
Pages: 505-512

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

Philippe de Moerloose 1, Gualtiero Palareti 2, Carlos Aguilar 3, Cristina Legnani 2, Guido Reber 1, Dirk Peetz4
1 Angiology and Haemostasis Division, University Hospital of Geneva and Faculty of Medicine, Geneva Switzerland; 2 Angiology and Blood Coagulation, University Hospital of Bologna, Italy; 3 Department of Haematology, General Hospital Santa Barbara, Soria, Spain; 4 Institute for Clinical Chemistry and Laboratory Medicine, University of Mainz, Mainz, Germany


pulmonary embolism, Deep venous thrombosis, D-dimer


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 particleenhanced 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.

You may also be interested in...


P. Prandoni (1)

Phlebologie 2017 46 5: 288-291

H. Leon Daneschvar 1, Ali Seddighzadeh 1, Gregory Piazza 2, Samuel Z. Goldhaber1

Thromb Haemost 2008 99 6: 1035-1039

Cihan Ay1,*, Lea V. Jungbauer2,*, Alexandra Kaider 3, Silvia Koder 1, Simon Panzer 4, Ingrid Pabinger 1, Christine Mannhalter2

Thromb Haemost 2008 99 5: 899-904