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Updated: Mar 6, 2026

Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes
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Analytical comparison between two hematological analyzer systems: CAL-8000 vs. XN-9000.

S Buoro1, T Mecca1, M Seghezzi1

  • 1Clinical Chemistry Laboratory, Hospital Papa Giovanni XXIII, Bergamo, Italy.

International Journal of Laboratory Hematology
|March 16, 2017
PubMed
Summary

This study compared CAL-8000 and XN-9000 hematology analyzers, finding significant differences in morphology flag generation. Harmonization or instrument-specific ranges are needed for accurate automated differential leukocyte counts.

Keywords:
CAL-8000XN-9000automated countmindrayoptical microscopysysmex

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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.