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

机译:白细胞形态结构参数(细胞群数据参数)质量控制评估与协调的初步建议

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Summary 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.
机译:背景技术Sysmex XN-9000测量的细胞群数据(CPD)可用于筛查许多血液学和非血液学疾病。由于在不同的仪器和临床实验室之间关于CPD协调的信息很少,因此本研究旨在评估分配给同一实验室的单独Sysmex XN模块之间CPD协调的当前程度。方法共有78291份数据用于验证运行中不精确度,分析仪协调性,参考范围以及CPD参数的血样稳定性评估,包括每日质量控制测试的结果以及从献血者和健康人收集的样本中产生的数据志愿者。结果CPD参数的运行内不精确度在0.4到14.1%之间。在五个不同的XN模块之间发现了良好的一致性,尤其是在计算特定于仪器的对准因子后调整值时。不管存储温度如何,在最多存储8小时的样品中,所有参数的偏差始终始终低于参考变化值。结论CPD参数的不精确性是可以接受的,除了那些反映细胞团分散的参数。由于缺乏参考对照材料,我们证明了使用在大量常规常规样品(即移动平均数)上生成的数据可能是测试分析仪协调一致的可靠方法。尽管如此,在将来强烈建议使用这些参数的校准材料和质量控制材料。我们最终表明,对于大多数CPD参数,全血样品可能在长达2-4小时内保持稳定。

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