Hemoscreen Point‐of‐Care Analyzer Compared With Sysmex XN‐1000 for Complete Blood Count in Pediatric Inpatients Aged 2 Months to 17 Years

INTRODUCTION: HemoScreen is an image-based point-of-care (POC) hematology analyzer that performs complete blood counts (CBC) from small blood volumes with minimal handling. These features are particularly relevant in pediatrics; however, comparative evidence with central laboratory analyzers in children remains limited. The primary outcome was analytical agreement for white blood cells (WBC), red blood cells (RBC), and platelets (PLT). Secondary outcomes included: (1) analytical agreement for hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), and mean platelet volume (MPV); and (2) diagnostic agreement for WBC, HGB, MCV, and PLT categories. Analytical agreement was evaluated using Passing-Bablok regression, Bland-Altman analysis, and proportions exceeding total allowable error (TEa) thresholds; Spearman's correlation was used to assess the strength of association between methods. Diagnostic agreement was quantified with Cohen's κ before and after Passing-Bablok alignment. RESULTS: Correlations were strong to excellent, with no significant deviation from linearity. Mean biases were below the minimum acceptable limits for most parameters. Using the Passing-Bablok regression as the reference line, the proportion of measurements exceeding limits was below 10% for WBC, RBC, PLT, and most other CBC indices in at least one of the tested TEa thresholds. Diagnostic agreement was excellent for leukopenia, leukocytosis, thrombocytopenia, anemia, and elevated HGB; good-excellent for thrombocytosis and macrocytosis; and good for microcytosis. CONCLUSION: In venous samples from pediatric inpatients (2 months-17 years), HemoScreen showed high analytical and diagnostic agreement with the Sysmex XN-1000, supporting its use in children's hospitals.