Kai C Wollert1, Tibor Kempf1, Evangelos Giannitsis2, Thomas Bertsch3, Siegmund L Braun4, Harald Maier5, Manfred Reim6, Robert H Christenson7. 1. Division of Molecular and Translational Cardiology, Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany. 2. Department of Internal Medicine III, Cardiology, University Hospital Heidelberg, Heidelberg, Germany. 3. Institute of Clinical Chemistry, Laboratory Medicine, and Transfusion Medicine, General Hospital Nuremberg, Paracelsus Medical University, Nuremberg, Germany. 4. Institute of Laboratory Medicine, German Heart Center Munich, Munich, Germany. 5. Central Laboratory, District Hospital Altötting-Burghausen, Altötting, Germany. 6. Roche Diagnostics, Penzberg, Germany. 7. Department of Pathology, University of Maryland School of Medicine, Baltimore, MD.
Abstract
BACKGROUND: Growth differentiation factor 15 (GDF-15) can serve as a biomarker for cardiovascular disease burden and risk. We evaluated a new, fully automated electrochemiluminescence immunoassay for measuring GDF-15. METHODS: Six laboratories independently characterized the Elecsys® GDF-15 assay (Roche Diagnostics) under routine conditions. Within-run precision (repeatability), within-laboratory precision (intermediate precision), and between-laboratory precision (reproducibility) were assessed. Plasma-serum sample correlation, reagent lot-to-lot reproducibility, and instrument comparisons were performed. The Elecsys assay was compared to a research immunoradiometric assay (IRMA) and a commercially available ELISA. GDF-15 concentrations were measured with the Elecsys assay in 739 apparently healthy individuals. RESULTS: CVs for within-run and within-laboratory precision ranged from 0.7% to 7.7% and 1.7% to 8.6%, respectively, for samples containing 670-16039 ng/L. CVs for between-laboratory precision ranged from 7.1% to 8.9% (766-14289 ng/L). Recovery of GDF-15 was comparable for serum, Li-heparin plasma, K2- and K3-EDTA plasma, and citrated plasma, between 2 reagent lots, and on the cobas e 411 and cobas e 601 analyzers (Roche Diagnostics). GDF-15 concentrations in the clinically relevant range (400-3000 ng/L) measured with the Elecsys assay showed a good correlation and agreement with those measured by IRMA or ELISA. GDF-15 concentrations in apparently healthy individuals increased with age but did not vary by sex. CONCLUSIONS: The Elecsys GDF-15 assay demonstrates a robust analytic performance under routine conditions and provides an automated method for measuring GDF-15 concentrations in serum and plasma.
BACKGROUND:Growth differentiation factor 15 (GDF-15) can serve as a biomarker for cardiovascular disease burden and risk. We evaluated a new, fully automated electrochemiluminescence immunoassay for measuring GDF-15. METHODS: Six laboratories independently characterized the Elecsys® GDF-15 assay (Roche Diagnostics) under routine conditions. Within-run precision (repeatability), within-laboratory precision (intermediate precision), and between-laboratory precision (reproducibility) were assessed. Plasma-serum sample correlation, reagent lot-to-lot reproducibility, and instrument comparisons were performed. The Elecsys assay was compared to a research immunoradiometric assay (IRMA) and a commercially available ELISA. GDF-15 concentrations were measured with the Elecsys assay in 739 apparently healthy individuals. RESULTS: CVs for within-run and within-laboratory precision ranged from 0.7% to 7.7% and 1.7% to 8.6%, respectively, for samples containing 670-16039 ng/L. CVs for between-laboratory precision ranged from 7.1% to 8.9% (766-14289 ng/L). Recovery of GDF-15 was comparable for serum, Li-heparin plasma, K2- and K3-EDTA plasma, and citrated plasma, between 2 reagent lots, and on the cobas e 411 and cobas e 601 analyzers (Roche Diagnostics). GDF-15 concentrations in the clinically relevant range (400-3000 ng/L) measured with the Elecsys assay showed a good correlation and agreement with those measured by IRMA or ELISA. GDF-15 concentrations in apparently healthy individuals increased with age but did not vary by sex. CONCLUSIONS: The Elecsys GDF-15 assay demonstrates a robust analytic performance under routine conditions and provides an automated method for measuring GDF-15 concentrations in serum and plasma.
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