144 Analytical Performance Evaluation of the Erythropoietin Assay on the Siemens Atellica IM Analyzer

Introduction/Objective The aim of this study was to evaluate the analytical performance of the Siemens Atellica IM Erythropoietin (EPO) assay (Siemens Healthineers, Tarrytown, NY) and compare it to an established method, the Beckman Coulter Access assay. Methods/Case Report We evaluated the Siemens Atellica IM EPO assay, a fully automated, one-step sandwich immunoassay with direct chemiluminescent detection. Analytical precision and linearity were assessed using manufacturer-provided standards. Method comparison was performed using 20 patient samples analyzed by both the Siemens Atellica and Beckman Coulter Access EPO assays (a two-site immunoenzymatic sandwich assay, Beckman Coulter, Brea, CA). Data were analyzed using Passing-Bablok regression and Bland-Altman plots. Results The Siemens Atellica EPO assay demonstrated excellent analytical performance, with intra-assay and inter-assay CVs ranging from 0.8–3.0% and 1.9–11.8%, respectively. The assay was linear across the validated range of 0.98–600 mIU/mL, with no significant deviation. Method comparison showed strong correlation between Siemens Atellica and Beckman Access assays (R² = 0.9973, slope = 1.23, intercept = –0.31). Conclusion The Siemens Atellica IM EPO assay demonstrated reliable analytical performance and was successfully validated for routine clinical use. Comparative analysis revealed a systematic positive bias versus the Beckman Access platform, which should be considered when interpreting results across methods.