Wollert Kai C, Kempf Tibor, Giannitsis Evangelos, Bertsch Thomas, Braun Siegmund L, Maier Harald, Reim Manfred, Christenson Robert H
Division of Molecular and Translational Cardiology, Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.
Department of Internal Medicine III, Cardiology, University Hospital Heidelberg, Heidelberg, Germany.
J Appl Lab Med. 2017 Mar 1;1(5):510-521. doi: 10.1373/jalm.2016.022376.
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.
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.
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.
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.
生长分化因子15（GDF - 15）可作为心血管疾病负担和风险的生物标志物。我们评估了一种用于测量GDF - 15的新型全自动电化学发光免疫测定法。
六个实验室在常规条件下独立对Elecsys® GDF - 15测定法（罗氏诊断）进行特性分析。评估批内精密度（重复性）、实验室内精密度（中间精密度）和实验室间精密度（再现性）。进行血浆 - 血清样本相关性、试剂批间再现性和仪器比较。将Elecsys测定法与研究用免疫放射测定法（IRMA）和市售酶联免疫吸附测定法（ELISA）进行比较。使用Elecsys测定法对739名明显健康个体的GDF - 15浓度进行测量。
对于含有670 - 16039 ng/L的样本，批内精密度和实验室内精密度的变异系数（CV）分别为0.7%至7.7%和1.7%至8.6%。实验室间精密度的CV为7.1%至8.9%（766 - 14289 ng/L）。血清、锂 - 肝素血浆、K2 - 和K3 - EDTA血浆以及枸橼酸盐血浆之间，2个试剂批次之间，以及在cobas e 411和cobas e 601分析仪（罗氏诊断）上，GDF - 15的回收率相当。使用Elecsys测定法在临床相关范围（400 - 3000 ng/L）内测量的GDF - 15浓度与通过IRMA或ELISA测量的浓度显示出良好的相关性和一致性。明显健康个体的GDF - 15浓度随年龄增加而升高，但不因性别而异。
Elecsys GDF - 15测定法在常规条件下表现出强大的分析性能，并提供了一种用于测量血清和血浆中GDF - 15浓度的自动化方法。
