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

INTRODUCTION

The aim of this study was to perform a verification of the hematology analyzer Sysmex XN-2000 by comparing with the previous XE-5000. This study assessed the precision and carryover on the XN-2000 and the systematic error between the both counters according to desirable biological variability criterion and a flag comparison study.

METHODS

Within-run precision and between-batch precision were measured according to the ICSH guidelines. A comparative study was performed analyzing two hundred and six samples of peripheral blood from patients. The statistical study was conducted using the Passing-Bablok and Bland-Altman analyses. The leucocyte flag comparison was made by measuring the efficiency rate.

RESULTS

Between-batch precision was lower than that recommended by the biological variability criterion and manufacturer specifications. The comparison gave nonagreement results for neutrophil and basophil counts according to the criterion of biological variability. Erythroblasts and immature granulocytes showed nonagreement, but there is no available biological variation database for these parameters to compare with. Nevertheless, excellent absolute agreement was found for red blood cell parameters, and for platelet, lymphocyte, monocyte, and eosinophil counts.

CONCLUSIONS

The global results obtained for the precision, comparability, and efficiency provide a satisfactory integration of the XN-2000 in the core laboratory routine and accomplish an optimal reliability.