Objective:

To evaluate the analytical agreement between the Atellica HEMA 580 and the Sysmex XN-1000 hematology analyzers using a standardized method-comparison approach.

Approach:

• Method Comparison: A total of 100 residual K₂EDTA whole-blood samples were analyzed on both systems following CLSI EP09c guidelines, including Passing–Bablok regression, Spearman correlation, bias estimation at predefined medical-decision levels, and Bland–Altman analysis.

Key Findings:

• Strong analytical agreement for most parameters with correlation coefficients exceeding 0.98 for RBC (r = 0.999), HGB (r = 0.998), WBC (r = 0.996), and PLT-I (r = 0.995).
• Bias estimates at medical-decision levels were within allowable limits for the majority of parameters.
• MCV showed proportional deviation with bias exceeding allowable limits at both 80 fL and 100 fL.
• RDW-CV demonstrated lower correlation (r = 0.848) and greater dispersion.
• Bland–Altman analysis confirmed small mean bias for RBC (−1.48%) and HGB (1.54%), while wider limits were observed for WBC and PLT-I.

Interpretation:

The Atellica HEMA 580 shows acceptable analytical agreement with the Sysmex XN-1000 for several CBC parameters, but MCV and RDW-CV exhibited analyzer-dependent differences.

Limitations:

• The study was conducted with a limited sample size of 100 specimens.
• Results may not be generalizable to all clinical settings or populations.

Conclusion:

The Atellica HEMA 580 shows acceptable analytical agreement with the Sysmex XN-1000 for several CBC parameters.