Schoorl M, Schoorl M, Chevallier M, van der Ploeg T, van Pelt J
Department of Clinical Chemistry, Haematology & Immunology, Northwest Clinics, Alkmaar, the Netherlands.
Foreest Medical School, Northwest Clinics, Alkmaar, the Netherlands.
Int J Lab Hematol. 2017 Oct;39(5):489-496. doi: 10.1111/ijlh.12674. Epub 2017 May 18.
Verification of hemocytometry equipment deviates significantly from that of clinical chemistry equipment due to the absence of appropriate control material and the need for fresh material. In practice, verification is limited to comparison with the previously used equipment and determination of reproducibilities. Particularly in multicenter settings, harmonization of results is necessary. If the same equipment is used in several laboratory departments, calibration and uniformity are important issues.
In this study, seven Sysmex XN hematology modules distributed over three laboratories were evaluated with the same set of samples (n=160).
Results of each Sysmex XN hematology module were compared with the results of the Sysmex XE-2100 hematology analyzer using linear regression. Although excellent correlation coefficients were obtained, in many cases the criteria for slope and/or intercept were not met. Therefore, the same data were analyzed with Bland-Altman difference plots with three times the specified CV% of the parameter as limits of agreement. At least 90% of the determinations per parameter and per module must comply with those limits of agreement. Almost all parameters on each module fulfilled these criteria, and only RBC and Ht from respectively two and four XN modules had to be recalibrated. Reproducibility of each parameter was determined 10 times in patient samples with low, normal, and high levels. Reproducibility of all parameters was within the specifications of the manufacturer and the biological variability.
With this straightforward method, all seven Sysmex XN hematology modules demonstrated uniform results, which were identical to those of the previously used Sysmex XE-2100 hematology analyzer, the performance of which was well known.
由于缺乏合适的对照材料且需要新鲜材料，血细胞计数设备的验证与临床化学设备的验证存在显著差异。在实际操作中，验证仅限于与先前使用的设备进行比较以及确定重复性。特别是在多中心环境中，结果的一致性是必要的。如果在多个实验室部门使用相同的设备，校准和一致性是重要问题。
在本研究中，使用同一组样本（n = 160）对分布在三个实验室的七个Sysmex XN血液学模块进行了评估。
使用线性回归将每个Sysmex XN血液学模块的结果与Sysmex XE - 2100血液分析仪的结果进行比较。尽管获得了出色的相关系数，但在许多情况下，斜率和/或截距的标准未得到满足。因此，使用Bland - Altman差异图对相同数据进行分析，将参数指定CV%的三倍作为一致性界限。每个参数和每个模块至少90%的测定必须符合这些一致性界限。每个模块上几乎所有参数都满足这些标准，只有分别来自两个和四个XN模块的RBC和Ht需要重新校准。在低、正常和高水平的患者样本中对每个参数的重复性进行了10次测定。所有参数的重复性均在制造商规定的规格和生物学变异范围内。
通过这种简单的方法，所有七个Sysmex XN血液学模块都显示出一致的结果，这些结果与先前使用的性能众所周知的Sysmex XE - 2100血液分析仪的结果相同。
