Multicenter verification of the Sysmex XN-Series.

Area of Science:

• Hematology
• Laboratory Medicine
• Medical Device Verification

Background:

• Hemocytometry equipment verification is challenging due to lack of control materials and need for fresh samples.
• Harmonization and uniformity are critical, especially in multicenter settings and across laboratory departments.
• Current verification often relies on inter-equipment comparison and reproducibility assessments.

Purpose of the Study:

• To evaluate the performance and uniformity of seven Sysmex XN hematology modules.
• To establish a straightforward verification method for multicenter laboratory harmonization.
• To ensure consistency of results with a previously validated analyzer (Sysmex XE-2100).

Main Methods:

• Seven Sysmex XN hematology modules across three laboratories were tested with 160 samples.
• Results were initially compared to a Sysmex XE-2100 analyzer using linear regression.
• Bland-Altman analysis with adjusted limits of agreement was employed for detailed evaluation.
• Reproducibility was assessed 10 times for each parameter using patient samples at varying levels.

Main Results:

• Linear regression showed excellent correlation, but slope/intercept criteria were often unmet.
• Bland-Altman analysis demonstrated that over 90% of determinations met the agreement criteria for most parameters.
• Only Red Blood Cell (RBC) and Hematocrit (Ht) required recalibration in a few modules.
• All tested parameters exhibited reproducibility within manufacturer specifications and biological variability.

Conclusions:

• The evaluated Sysmex XN hematology modules demonstrated uniform and consistent performance.
• The straightforward verification method confirmed results identical to the established Sysmex XE-2100 analyzer.
• This approach facilitates harmonization and ensures reliable diagnostic data in multicenter laboratory settings.