Performance evaluation of the new Sysmex XR-Series haematology analyser

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine Pub Date : 2024-02-15 DOI:10.1016/j.plabm.2024.e00370

Kenichi Fujimaki , Kornelia Hummel , Immaculate Magonde , Katharina Dammert , Yoshiko Hamaguchi , Konstantinos Mintzas , Jarob Saker , Ondrej Valina , Klaus-Martin Otte

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引用次数: 0

Abstract

Background

The new XR-Series haematology analyser from Sysmex provides increased throughput and automation, along with a new reagent in WDF channel for optimised WBC differential.

Methods

An analytical performance study for the XR analyser was conducted to evaluate the WDF channel parameters in comparison to the instrument specifications. Additionally, 7460 samples were measured on XR and XN analysers to compare selected parameters and flags, and 930 randomly selected samples were further evaluated with microscopy.

Results

All investigated aspects of the analytical performance study for the XR fell within the manufacturer specifications. The correlation coefficients between the two systems for the parameters tested were greater than 0.983 for the main CBC and DIFF parameters, greater than 0.909 for the Extended Inflammation Parameters, and greater than 0.932 for the parameters used in the workflow rulesets of the Extended IPU. Similarly high sensitivities for the detection of abnormal cells were observed for the ‘Blasts/Abn Lympho?’ flag (XN: 100%, XR: 99.0%) and WPC abnormal flags (‘Blasts?’ or ‘Abn Lympho?‘) (XN: 97.0%, XR: 96.0%). XN with WPC channel had a 26% reduction of false positive smears compared to XR with 22% reduction, a statistically non-significant difference.

Conclusion

The XR analyser had very good analytical performance, and highly comparable results to the predecessor XN analyser in all investigated parameters, flags and workflow aspects.

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新型 sysmex XR 系列血液分析仪性能评估

背景Sysmex公司的新型XR系列血液分析仪提高了通量和自动化程度，并在WDF通道中加入了新的试剂，以优化白细胞差值。方法对XR分析仪进行了分析性能研究，以评估WDF通道参数与仪器规格的比较。此外，在 XR 和 XN 分析仪上测量了 7460 个样品，以比较选定的参数和标志，并用显微镜进一步评估了随机挑选的 930 个样品。两个系统测试参数的相关系数分别为：主要 CBC 和 DIFF 参数大于 0.983，扩展炎症参数大于 0.909，扩展 IPU 工作流程规则集所用参数大于 0.932。在检测异常细胞方面，"Blasts/Abn Lympho? "标记（XN：100%，XR：99.0%）和 WPC 异常标记（"Blasts? "或 "Abn Lympho?"）（XN：97.0%，XR：96.0%）的灵敏度同样很高。带有 WPC 通道的 XN 与 XR 相比，假阳性涂片减少了 26%，而 XR 减少了 22%，两者之间的差异在统计学上并不显著。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

期刊介绍： Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.