Evaluation of the Innovance D-DIMER analytical performance

• Published in: Clinical chemistry and laboratory medicine Vol. 47; no. 8; pp. 945 - 951
• Main Authors: Coen Herak, Desiree, Milos, Marija, Zadro, Renata
• Format: Journal Article
• Language: English
• Published: Berlin Walter de Gruyter 01.08.2009; De Gruyter
• Subjects: Biological and medical sciences; coagulation; D-dimer; evaluation; Fibrin Fibrinogen Degradation Products - analysis; General aspects; Humans; Immunoassay; Investigative techniques, diagnostic techniques (general aspects); Linear Models; Medical sciences; Nephelometry and Turbidimetry - methods; particle-enhanced immunoturbidimetric assay; Reagent Kits, Diagnostic; Sensitivity and Specificity; Performance evaluation; Blood coagulation; D-dimer; particle-enhanced immunoturbidimetric assay; D dimer; coagulation; Assay; Medicine; Particle; evaluation; Clinical biology; Turbidimetry; Performance
• DOI: 10.1515/CCLM.2009.219
• ISSN: 1434-6621

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.