Clinical Evaluation of a Novel Point-of-Care Hematology Analyzer for Complete Blood Count With Differential.

INTRODUCTION

Point-of-care testing (POCT) for hematology enables clinicians to access actionable results during patient visits, supporting timely decisions such as transfusions or chemotherapy adjustments. However, POCT analyzers must demonstrate clinical performance comparable to centralized laboratory systems. We conducted a proof-of-concept evaluation of the HemoScreen (PixCell Medical, Israel) hematology POCT analyzer across diverse clinical settings in an integrated healthcare system.

METHODS

EDTA whole blood specimens from inpatient wards, emergency departments, outpatient clinics, and infusion centers underwent routine CBC testing on a Sysmex XN analyzer (Sysmex Corporation, Japan) at the central laboratory. Residual, de-identified samples were tested within 10 min on a HemoScreen analyzer. All parameters and instrument flags were recorded.

RESULTS

From 9/15/2020 to 11/20/2020, 199 samples were analyzed, including 49 from the emergency department and 50 each from inpatient, outpatient, and infusion center settings. HGB, RBC, PLT, WBC, and absolute neutrophil count showed strong linear correlations (R2 = 0.91-0.98) and no significant differences between instruments (p > 0.29). HCT and MCV values were significantly lower on HemoScreen (bias -5% and -3.6%; p = 0.010 and p < 0.001, respectively), with modestly reduced correlations (R2 = 0.80-0.89). Neutrophil percentage was higher on HemoScreen (bias +9.0%, p < 0.001), whereas monocyte counts were significantly lower (bias -50%, p < 0.001).

CONCLUSION

HemoScreen demonstrated generally acceptable agreement with the Sysmex XN for most parameters. However, systematic differences in HCT, MCV, neutrophil, and monocyte results warrant further investigation to assess clinical impact before broader implementation.