Analytical Performance Evaluation of the Sysmex XR-9000 Hematology Analyzer in a Clinical Laboratory Setting

Background: Automated hematology analyzers are essential for clinical diagnostics.We evaluated the analytical performance of the Sysmex XR-9000 (Sysmex Corporation, Kobe, Japan) by comparing it with the XN-9000 (Sysmex Corporation) system.Methods: Analytical performance of the XR series was evaluated including carryover, within-laboratory precision, linearity, and sensitivity.Method comparison was performed using clinical samples for complete blood count (N=120), reticulocytes (N=74), eosinophil count (N=337), and hematopoietic progenitor cells (HPC; N=40, including 13 peripheral blood stem cell products) using Passing-Bablok regression analysis and Bland-Altman analysis.Flagging performance was evaluated using 355 samples with manual differential counts as the reference method.Overall agreement was assessed using manufacturer recommended cutoffs and reference intervals were verified in 40 healthy individuals.Results: Carryover rates were ≤ 0.13%, within-laboratory precision met predefined acceptance criteria, and linearity was confirmed across the analytical measuring intervals (r>0.999).Method comparison showed regression slopes ranging from 0.991 to 1.034 for major hematologic parameters, including white blood cell (WBC), red blood cell, and WBC differential counts.For HPC enumeration, correlation coefficients were 0.964 and 0.985 for absolute counts and percentages, respectively.Flagging performance varied by specific parameter: the 'IG Present (immature granulocyte)' flag showed 100.0%sensitivity and 83.9% specificity, while morphological flags like 'Blasts/Abn Lympho?' showed 65.0% sensitivity and 70.4% specificity.Established reference intervals were verified.Conclusions: In this first Korean evaluation, the Sysmex XR-9000 showed acceptable analytical performance for routine hematology parameters and HPC enumeration with precision, linearity, and method comparison results comparable to those of the XN-9000.