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.
Authors' Disclosures or Potential Conflicts of Interest: Upon manuscript submission, all authors completed the author disclosure form.
Employment or Leadership: M. Reim, Roche Diagnostics.
Consultant or Advisory Role: R.H. Christenson, Roche Diagnostics, Siemens Healthcare Diagnostics, and Abbott Diagnostics.
Stock Ownership: None declared.
Honoraria: R.H. Christenson, Roche Diagnostics, Siemens Diagnostics, Philips Diagnostics, and Beckman Coulter.
Research Funding: K.C. Wollert, T. Kempf, T. Bertsch, S.L. Braun, H. Maier, Roche Diagnostics; R.H. Christenson, Roche Diagnostics to institution. Expert Testimony: None declared.
Patents: K.C. Wollert, T. Kempf, EP 2047275 B1 and US 8951742 B2.
Other Remuneration: E. Giannitsis, Roche Diagnostics, Bayer Vital, and AstraZeneca.
Role of Sponsor: The funding organizations played a direct role in design and choice of enrolled patients.
- Received October 20, 2016.
- Accepted November 30, 2016.
- © 2016 American Association for Clinical Chemistry