Thromb Haemost 2008; 100(03): 505-512
DOI: 10.1160/TH08-04-0202
New Technologies, Diagnostic Tools and Drugs
Schattauer GmbH

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

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

Publication History

Received 01 April 2008

Accepted after major revision 18 June 2008

Publication Date:
22 November 2017 (online)

Summary

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 immuno assay 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.

 
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