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Licensed Unlicensed Requires Authentication Published by De Gruyter June 24, 2009

Evaluation of the Innovance D-DIMER analytical performance

Desiree Coen Herak, Marija Milos and Renata Zadro

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.


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

Received: 2009-2-23
Accepted: 2009-5-7
Published Online: 2009-06-24
Published in Print: 2009-08-01

©2009 by Walter de Gruyter Berlin New York

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