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Thromb Haemost 2000; 84(05): 770-774
DOI: 10.1055/s-0037-1614113
Review Article
Schattauer GmbH

Preliminary Evaluation of two New Rapid Immunoturbidimetric D-dimer Assays in Patients with Clinically Suspected Venous Thromboembolism (VTE)

Lucie L. Houbouyan-Reveillard
2   From Hospital Ambroise Paré, Boulogne, France, The Netherlands
,
Amine Mihoubi
2   From Hospital Ambroise Paré, Boulogne, France, The Netherlands
,
Wim P. M. Houdijk
1   Organon Teknika bv, Boxtel, The Netherlands
,
Salah Qanadli
2   From Hospital Ambroise Paré, Boulogne, France, The Netherlands
,
Thierry Joseph
2   From Hospital Ambroise Paré, Boulogne, France, The Netherlands
,
Jean-Paul Courret
2   From Hospital Ambroise Paré, Boulogne, France, The Netherlands
,
Bernard Page
2   From Hospital Ambroise Paré, Boulogne, France, The Netherlands
,
Alain F. Goguel
2   From Hospital Ambroise Paré, Boulogne, France, The Netherlands
› Author AffiliationsThe authors thank the medical staff of the Hospital Ambroise Paré (Departments of Radiology, Cardiology, Emergency, Pulmonology and Internal Medicine) for patient selection and diagnosis, Andrew Stead (Organon Teknika Corp, Durham, NC, USA) for performing the statistical analysis, and Alan Giles, M. D. (Queen’s University, Kingston, Ontario, Canada) for critical reading of the manuscript.
Further Information

Publication History

Received 14 December 1999

Accepted after resubmission 30 May 2000

Publication Date:
13 December 2017 (online)

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Summary

The practical utility and diagnostic accuracy of two new rapid, automated and quantitative immunoturbidimetric D-dimer methods have been evaluated in a population of 123 randomly selected patients with suspected VTE. The STA Liatest D-dimer and MDA D-dimer methods are based on the photo-optical measurement of the rate of agglutination of antibody-coated latex particles. The VIDAS D-dimer automated Elisa was used as the reference method. Diagnosis was confirmed in 51 patients (29 PE, 19 DVT, 3 DVT+PE). The immunoturbidimetric methods compared favorably with the VIDAS Elisa as judged from the correlation coefficients of linear regression lines (r = 0.82, MDA vs VIDAS; r = 0.75, STA vs VIDAS) and areas under the curve of ROC plots (VIDAS 0.83; STA 0.83; MDA 0.81). At a discriminant value of 500 ng/mL, all three D-dimer assays showed high sensitivity (96-98%), high NPV (93-97%) and moderate specificity (39-42%). Reproducibility of results around the cut-off is an important aspect of the diagnostic utility of D-dimer assays. CV's of duplicate determinations in this critical zone showed average values of 5.4% and 17.0% for MDA and STA, respectively. These data demonstrate that such rapid and automated latex-based methods for the quantitative measurement of D-dimer hold promise as reliable and cost-efficient approaches for the exclusion of VTE. Prospective patient management studies will be required to confirm this.

Key words

Ddimer - deep vein thrombosis - pulmonary embolism
 

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