A Preliminary Proposal for Quality Control Assessment and Harmonization of Leukocytes Morphology-structural Parameters (cell Population Data Parameters).

BACKGROUND: The cell population data (CPD) measured by Sysmex XN-9000 can be used for screening many hematological and non-hematological disorders. Since little information is available on harmonization of CPD among different instrumentation and clinical laboratories, this study aimed at assessing the current degree of CPD harmonization between separate Sysmex XN modules allocated to the same laboratory. METHODS: A total number of 78291 data were used for verification of within-run imprecision, analyzers harmonization, reference ranges and assessment of blood sample stability of CPD parameters, including results of daily quality control testing and those generated in samples collected from blood donors and healthy volunteers. RESULTS: Within-run imprecision of CPD parameters ranged between 0.4 and 14.1%. Good agreement was found among five different XN-modules, especially when values were adjusted after calculation of instrument-specific alignment factors. The bias of all parameters remained always lower than the reference change values in samples stored for up to 8 hours, regardless of storage temperature. CONCLUSIONS: The imprecision of CPD parameters was acceptable, except for those reflecting the dispersion of cellular clusters. Due to the lack of reference control materials, we showed that the use of data generated on a large number of normal routine samples (i.e., a Moving Average population) may be a reliable approach for testing analyzers harmonization. Nevertheless, availability of both calibration and quality control materials for these parameters is highly advisable in the future. We finally showed that whole blood samples may be stable for up to 2-4 hours for most CPD parameters.