Analytical Verification and Method Comparison of the Atellica HEMA 580 Hematology Analyzer for Routine Clinical...

Accurate complete blood count (CBC) measurements are fundamental to modern hematology practice, and the introduction of new automated hematology analyzers requires rigorous analytical validation to ensure reliability, comparability, and clinical safety. The Atellica HEMA 580 (Siemens Healthineers AG, Erlangen, Germany) is a high-throughput hematology analyzer for which independent Clinical and Laboratory Standards Institute (CLSI)-guided validation data remain limited. This study aimed to perform a comprehensive analytical validation of the Atellica HEMA 580 and to evaluate its analytical comparability with the Sysmex XN-3100 (Sysmex Corporation, Kobe, Japan). Analytical validation was conducted in accordance with CLSI guidelines. Precision was assessed following CLSI EP05-A3, linearity according to EP06-A, carryover using EP07-A2, and method comparison per EP09-A3. Precision was evaluated using 15 within-run and 15 inter-assay replicates across three quality control levels. Linearity was evaluated using proportional dilution from neat to 1:16. Forty-four paired routine clinical samples were analyzed in parallel on both analyzers using ordinary least squares, Passing-Bablok, and Deming regression, supplemented by Bland-Altman analysis. Within-run analytical imprecision was low, with coefficients of variation of 0.76% for white blood cells, 0.73% for red blood cells, 0.25% for hemoglobin, and 3.59% for platelets, together with stable inter-assay reproducibility. Linearity of red blood cell and hemoglobin measurements demonstrated high proportionality across the evaluated analytical ranges. Platelet method comparison demonstrated a modest negative proportional bias (Deming slope 0.95; 95% confidence interval, 0.91-0.99). High correlation coefficients across major hematological parameters further supported strong analytical agreement between the two analyzers. Bland-Altman analysis showed minimal systematic bias, and carryover remained low across all parameters. Atellica HEMA 580 met CLSI analytical validation criteria and demonstrated analytical agreement with the Sysmex XN platform, supporting its use in routine and high-throughput hematology laboratories.