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评价希森美康 XQ-320 三分群血液学分析仪及其标记功能。

Evaluation of the Sysmex XQ-320 three-part differential haematology analyser and its flagging capabilities.

机构信息

General Haematology Laboratory, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.

Sysmex Europe SE, Norderstedt, Germany.

出版信息

J Clin Lab Anal. 2024 Feb;38(4):e25017. doi: 10.1002/jcla.25017. Epub 2024 Feb 23.

Abstract

BACKGROUND

Three-part differential (3PD) haematology analysers offer a quick, easy-to-use and economical way to acquire important information about a patient's physiology. In this study, we evaluated a new 3PD analyser, the Sysmex XQ-320, investigated its comparability with its predecessor (Sysmex XP-300) and the five-part differential analyser Sysmex XN-9000, and explored its flagging potential.

METHODS

Analytical performance studies were conducted for repeatability, within-laboratory precision, between-day precision, carry-over and linearity with fresh blood and QC material. Method comparison was performed in 493 samples comparing XQ-320 with XP-300, using the XN-9000 as the gold standard.

RESULTS

The XQ-320 excelled manufacturer's specifications in the analytical performance studies, except for MXD in within-laboratory and between-day precisions using the QC material level 1. The XQ-320 showed correlation values greater than 0.94 with XN-9000 for the majority of the 20 reportable parameters (MXD# 0.891, MXD% 0.898 and MCHC 0.849). Improvements over the XP-300 were observed in WBC in the leucocytopenic range (bias -0.038 vs. -0.097) and PLT (bias 2.568 vs. -7.877, intercept 3.880 vs. -8.845). Concordance between XQ-320 and XP-300 was 91.9% for the WBC histogram abnormal distribution flag and 95.3% for the PLT flag. Patterns of increased neutrophils and decreased mixed cells on the XQ-320 were observed in samples that raised a flag on XN-9000.

CONCLUSION

The XQ-320 showed excellent analytical performance, and very good to excellent correlation with XN-9000 with improvements over XP-300. Flagging combined with parameter patterns identified additional suspected abnormal samples, thus making the XQ-320 an excellent solution for laboratories utilising 3PD analysers.

摘要

背景

三分群(3PD)血液分析仪提供了一种快速、易用且经济的方法,可以获取有关患者生理机能的重要信息。在这项研究中,我们评估了一种新的 3PD 分析仪,即希森美康 XQ-320,研究了它与前代产品(希森美康 XP-300)和五分类血液分析仪希森美康 XN-9000 的可比性,并探讨了它的标记潜力。

方法

对重复性、实验室内部精密度、日间精密度、携带污染和新鲜血液及 QC 材料的线性进行了分析性能研究。在 493 个样本中,将 XQ-320 与 XP-300 进行了方法比较,以 XN-9000 为金标准。

结果

除了使用 QC 材料 1 级时,实验室内部和日间精密度的 MXD 外,XQ-320 在分析性能研究中均优于制造商的规格。对于大多数 20 个可报告参数,XQ-320 与 XN-9000 的相关系数均大于 0.94(MXD#0.891、MXD%0.898 和 MCHC0.849)。与 XP-300 相比,WBC 在白细胞减少范围内(偏差-0.038 对-0.097)和 PLT(偏差 2.568 对-7.877,截距 3.880 对-8.845)有所改善。XQ-320 与 XP-300 的 WBC 直方图异常分布标记的一致性为 91.9%,PLT 标记的一致性为 95.3%。在 XN-9000 上标记的样本中,XQ-320 观察到中性粒细胞增多和混合细胞减少的模式。

结论

XQ-320 表现出优异的分析性能,与 XN-9000 具有非常好到极好的相关性,并优于 XP-300。标记与参数模式相结合,确定了其他疑似异常的样本,因此,XQ-320 是使用 3PD 分析仪的实验室的理想解决方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4239/10943257/6e0d2919dc7c/JCLA-38-e25017-g001.jpg

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