Performance evaluation of the new Sysmex XR9000 hematology system in a clinical setting in comparison with Sysmex XN9100

This study evaluted the Sysmex XR-9000 hematology analyzer in a clinical setting, comparing it with the XN-9100 system using patient samples from routine laboratory. The evaluation followed CLSI H26-A2 and ICSH guidelines, incorporating state-of-the-art (SOTA) and EFLM biological variation criteria. The XR-9000 met LLoQ criteria for leukocyte and platelet counts using the White cell Differential channel by Fluorescence (WDF) and platelet fluorescence (PLT-F) channels, with CV% below 7% for WBC at 0.1 x10⁹/L and platelets at 1.5 x10⁹/L. Linearity was excellent across all parameters (r² > 0.99) and imprecision reported by the manufacturer was verified. For Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), and Mean Corpuscular Hemoglobin Concentration (MCHC), CV% values reached 0.7%, 1.3%, and 1.7%, respectively, exceeding EFLM criteria of 0.4%, 0.3%, and 0.5%. The low concentration controls for neutrophils counts (NEUT) and platelets exceeded SOTA limits of 2.5% and 3%, respectively, with CV% up to 3.6% and 4.1%. Clinically relevant levels for platelets, hemoglobin, and NEUT showed acceptable imprecision with CV% <5, ≤1.3, and <9, respectively. Accuracy testing confirmed agreement with manufacturer's controls and an EQA program, with immature granulocytes as the only exception due to its level falling below LLoQ. Method comparison between the XR-9000 and XN-9100 systems demonstrated strong agreement, with minor discrepancies in MCHC, basophils count (BASO), and platelets. In conclusion, the XR-9000 demonstrated reliable performance across key metrics, meeting clinical requirements for accurate diagnosis and monitoring in hematology.