An Automated Assay for Growth Differentiation Factor 15

Kai C Wollert; Tibor Kempf; Evangelos Giannitsis; Thomas Bertsch; Siegmund L Braun; Harald Maier; Manfred Reim; Robert H Christenson

doi:10.1373/jalm.2016.022376

An Automated Assay for Growth Differentiation Factor 15

J Appl Lab Med. 2017 Mar 1;1(5):510-521. doi: 10.1373/jalm.2016.022376.

Authors

Kai C Wollert¹, Tibor Kempf¹, Evangelos Giannitsis², Thomas Bertsch³, Siegmund L Braun⁴, Harald Maier⁵, Manfred Reim⁶, Robert H Christenson⁷

Affiliations

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.

PMID: 33379802
DOI: 10.1373/jalm.2016.022376

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.