A-240 Multicenter Performance Evaluation and Method Comparison of the Yumizen H550 Hematology Analyzer
Abstract
Accurate hematological analysis is critical for clinical decision-making across diverse patient populations. This study evaluates the performance of the Yumizen H550, a compact hematology analyzer, by comparing it to the established Yumizen H2500 predicate device. The evaluation aimed to validate the H550’s accuracy across a broad analytical measuring range, including both normal and pathological samples. A multicenter study was conducted at three clinical sites: Baylor Scott & White Medical Center (Texas, US), Columbia University Medical Center (New York, and CHU Nîmes (France). Following CLSI EP09c guidelines, at least 250 specimens were analyzed at each site, totaling over 750 samples. The study included adult and pediatric subjects (neonate to <22 years), utilizing both venous and capillary whole blood samples collected in K2EDTA. Samples were analyzed in DIF mode on both the Yumizen H550 and H2500 within established stability timeframes. Data analysis was performed using Passing-Bablok regression to estimate bias and correlation for CBC and differential parameters. The Yumizen H550 demonstrated strong correlation with the H2500 across all primary parameters, including White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB), Hematocrit (HCT), and Platelets (PLT). Summary data indicated that the H550 met all pre-defined acceptance criteria for method comparison. Predicted bias at critical medical decision points for parameters such as HGB, MCV, and Neutrophil absolute counts remained within clinically acceptable limits. The analyzer effectively identified various pathologies, including leukocytosis, anemia, and thrombocytopenia, as well as abnormal cell types like schistocytes and immature granulocytes. The Yumizen H550 shows excellent analytical agreement with the high-throughput Yumizen H2500 platform. Its robust performance across diverse age groups and pathological conditions confirms its suitability for clinical laboratory environments requiring reliable, low-to-mid volume hematology testing.