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Sysmex DI-60在白细胞减少样本中的数据可重复性如何?

How Reproducible Is the Data from Sysmex DI-60 in Leukopenic Samples?

作者信息

Yoon Sumi, Hur Mina, Lee Gun Hyuk, Nam Minjeong, Kim Hanah

机构信息

Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul 06973, Korea.

Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul 05030, Korea.

出版信息

Diagnostics (Basel). 2021 Nov 23;11(12):2173. doi: 10.3390/diagnostics11122173.

Abstract

Digital morphology (DM) analyzers are widely applied in clinical practice. It is necessary to evaluate performances of DM analyzers by focusing on leukopenic samples. We evaluated the analytical performance, including precision, of a Sysmex DI-60 system (Sysmex, Kobe, Japan) on white blood cell (WBC) differentials in leukopenic samples. In a total of 40 peripheral blood smears divided into four groups according to WBC count (normal, mild, moderate, and severe leukopenia; each group = 10), we evaluated precision of WBC preclassificaiton by DI-60. %coefficients of variation (%CVs) of precision varied for each sample and for each cell class; the fewer cells per slide, the higher %CV. The overall specificity and efficiency were high for all cell classes except plasma cells (95.9-99.9% and 90.0-99.4%, respectively). The largest absolute value of mean difference between DI-60 and manual count in each group was: 10.77, normal; 10.22, mild leukopenia; 19.09, moderate leukopenia; 47.74, severe leukopenia. This is the first study that evaluated the analytical performance of DI-60 on WBC differentials in leukopenic samples as the main subject. DI-60 showed significantly different performance depending on WBC count. DM analyzers should be evaluated separately in leukopenic samples, even if the overall performance was acceptable.

摘要

数字形态学(DM)分析仪在临床实践中得到广泛应用。有必要通过关注白细胞减少样本评估DM分析仪的性能。我们评估了Sysmex DI - 60系统(Sysmex,日本神户)在白细胞减少样本中白细胞(WBC)分类方面的分析性能,包括精密度。在总共40份外周血涂片样本中,根据白细胞计数分为四组(正常、轻度、中度和重度白细胞减少;每组10份),我们评估了DI - 60对白细胞预分类的精密度。精密度的变异系数百分比(%CVs)因每个样本和每个细胞类别而异;每张玻片上的细胞越少,%CV越高。除浆细胞外,所有细胞类别的总体特异性和效率都很高(分别为95.9 - 99.9%和90.0 - 99.4%)。每组中DI - 60与手工计数之间平均差异的最大绝对值为:正常组10.77;轻度白细胞减少组10.22;中度白细胞减少组19.09;重度白细胞减少组47.74。这是第一项以白细胞减少样本中白细胞分类为主要研究对象评估DI - 60分析性能的研究。DI - 60的性能根据白细胞计数显示出显著差异。即使总体性能可以接受,DM分析仪在白细胞减少样本中也应单独评估。

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