Seghezzi Michela, Buoro Sabrina, Previtali Giulia, Moioli Valentina, Manenti Barbara, Simon-Lopez Ramon, Ottomano Cosimo, Lippi Giuseppe
Clinical Chemistry Laboratory, Hospital Papa Giovanni XXIII, Bergamo, Italy.
Sysmex Corporation, Chuo-ku Japan.
J Med Biochem. 2018 Dec 1;37(4):486-498. doi: 10.2478/jomb-2018-0005. eCollection 2018 Dec.
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.
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.
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.
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.
Sysmex XN - 9000检测的细胞群体数据（CPD）可用于筛查多种血液系统和非血液系统疾病。由于关于不同仪器和临床实验室之间CPD一致性的信息较少，本研究旨在评估分配到同一实验室的不同Sysmex XN模块之间当前的CPD一致性程度。
总共78291个数据用于验证批内不精密度、分析仪一致性、参考范围以及评估CPD参数的血样稳定性，包括每日质量控制检测结果以及从献血者和健康志愿者采集的样本中生成的数据。
CPD参数的批内不精密度在0.4%至14.1%之间。在五个不同的XN模块之间发现了良好的一致性，特别是在计算特定仪器校准因子后对值进行调整时。在长达8小时的储存时间内，无论储存温度如何，所有参数的偏差始终低于参考变化值。
除了反映细胞簇分散情况的参数外，CPD参数的不精密度是可以接受的。由于缺乏参考对照材料，我们表明使用大量正常常规样本（即移动平均群体）生成的数据可能是测试分析仪一致性的可靠方法。然而，未来非常建议为这些参数提供校准和质量控制材料。我们最终表明，对于大多数CPD参数，全血样本在长达2 - 4小时内可能是稳定的。
