International journal of laboratory hematology · 2026
Hemoscreen Point-of-Care Analyzer Compared With Sysmex XN-1000 for Complete Blood Count in Pediatric Inpatients Aged 2 Months to 17 Years.
СтатьяСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Correani Alessio, Niccoletti Beatrice, Pavani Marianna, Sampaolo Michela, Finaurini Lucia, Pelloso Michela, Montagnana Martina, Moretti Marco
Аннотация
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.
METHODS: We compared HemoScreen POC with Sysmex XN-1000 analyzer in 141 venous K2-EDTA samples from pediatric inpatients aged 2 months-17 years. 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.
METHODS: We compared HemoScreen POC with Sysmex XN-1000 analyzer in 141 venous K2-EDTA samples from pediatric inpatients aged 2 months-17 years. 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.