Local verification between the hematological analyzers Sysmex XN-series and XE-5000

Area of Science:

• Clinical diagnostics
• Hematology automation
• Laboratory medicine

Background:

• Verification of new hematology analyzers is crucial for reliable diagnostic testing.
• The Sysmex XN-2000 is a new automated hematology system requiring performance evaluation.
• Comparison with established systems like the Sysmex XE-5000 provides a benchmark for validation.

Purpose of the Study:

• To verify the performance of the Sysmex XN-2000 hematology analyzer.
• To compare the Sysmex XN-2000 with the Sysmex XE-5000, assessing precision, carryover, and systematic error.
• To evaluate analytical performance against biological variability criteria and flag comparison studies.

Main Methods:

• Precision (within-run and between-batch) assessed per ICSH guidelines.
• Comparative analysis of 206 peripheral blood samples using Sysmex XN-2000 and XE-5000.
• Statistical evaluation via Passing-Bablok and Bland-Altman analyses; leucocyte flag efficiency measured.

Main Results:

• Between-batch precision did not meet biological variability criteria or manufacturer specifications for some parameters.
• Non-agreement observed for neutrophil and basophil counts based on biological variability.
• Excellent agreement found for red blood cell parameters, platelets, lymphocytes, monocytes, and eosinophils.

Conclusions:

• The Sysmex XN-2000 demonstrates satisfactory integration into core laboratory routines.
• Overall precision, comparability, and efficiency indicate optimal reliability for routine diagnostics.
• While most parameters show excellent agreement, specific cell counts require careful monitoring.