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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Tate, Jillian R. / Tsongalis, Gregory J.

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Evaluation of the Innovance D-DIMER analytical performance

Desiree Coen Herak1 / Marija Milos1 / Renata Zadro1

1Clinical Institute of Laboratory Diagnosis, Clinical Hospital Center Zagreb and University School of Medicine, Zagreb, Croatia

Corresponding author: Renata Zadro, Clinical Institute of Laboratory Diagnosis, Zagreb University School of Medicine and Clinical Hospital Center, Zagreb, Croatia Phone: +38512367360, Fax: +38512367395,

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 47, Issue 8, Pages 945–951, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2009.219, June 2009

Publication History

Received:
2009-02-23
Accepted:
2009-05-07
Published Online:
2009-06-24

Abstract

Background: Widespread use of D-dimer in recent years has led to the development of a number of new fully automated quantitative D-dimer assays.

Methods: We evaluated the analytical performance of the particle-enhanced immunoturbidimetric assay Innovance D-DIMER (Siemens Medical Solutions) on the Behring Coagulation System (BCS) analyzer.

Results: Within-run coefficients of variation (CVs) for samples with low, borderline, slightly, and extremely increased D-dimer concentrations were 2.1%–5.5%, whereas between-run CVs for control samples with low and extremely increased D-dimer were 5.5%–8.4%. The assay exhibited good linearity in the working range between 0.17 mg/L and 5.45 mg/L fibrinogen equivalent units (FEU), with the lower limit of detection of 0.099 mg/L FEU. The upper reference value determined in 40 plasma samples from healthy volunteers was 0.495 mg/L FEU. The results obtained in 457 fresh plasma samples were compared with results obtained with VIDAS D-Dimer Exclusion. Passing and Bablok regression analysis demonstrated highly significant correlation (y=1.370x–0.108, r=0.952, p<0.001). Bland and Altman difference plots demonstrated slightly higher results obtained with Innovance D-DIMER that was more pronounced with increasing values. Very good agreement between both assays was observed (κ=0.860; 95% confidence interval (CI), 0.811–0.908).

Conclusions: This study demonstrates that Innovance D-DIMER fulfills all analytical requirements for daily routine use.

Clin Chem Lab Med 2009;47:945–51.

Keywords: coagulation; D-dimer; evaluation; particle-enhanced immunoturbidimetric assay

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