Analytical comparison between two hematological analyzer systems: CAL-8000 vs. XN-9000

Area of Science:

• Hematology
• Clinical Chemistry
• Medical Laboratory Science

Background:

• Automated hematology analyzers are crucial for differential leukocyte counts (DIFF profile).
• Morphological flags aid in identifying abnormal cells, but their performance varies between instruments.
• Comparing new (CAL-8000) and established (XN-9000) analyzers is essential for diagnostic accuracy.

Purpose of the Study:

• To compare the analytical performance of CAL-8000 and XN-9000 hematology analyzers.
• To evaluate traditional and new parameters, including morphological flags, against optical microscopy (OM).
• To assess the agreement of automated DIFF profiles with manual microscopic review.

Main Methods:

• 1025 peripheral blood samples were analyzed on CAL-8000, XN-9000, and by OM.
• Within-run imprecision was assessed in low cellularity samples.
• Statistical analyses included Spearman's correlation, Passing-Bablok regression, Bland-Altman bias, and Cohen's K test.

Main Results:

• CAL-8000 and XN-9000 showed reproducible data for within-run imprecision, except for low platelet counts.
• Passing-Bablok regression revealed varying slopes and intercepts between analyzers for leukocyte, RBC, platelet, and reticulocyte parameters.
• Morphological flag comparison yielded Cohen's K values <0.55, indicating poor agreement; DIFF profiles showed bias ranging from -42.9% to 35.0% compared to OM.

Conclusions:

• Significant analytical differences exist between the CAL-8000 and XN-9000 analyzers.
• The generation of morphology flags showed particular discordance between the instruments.
• Harmonization of analytical methods or adoption of instrument-specific reference ranges is recommended for improved diagnostic consistency.