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希森美康XS-1000i全自动血液分析仪的性能评估

Performance evaluation of the Sysmex XS-1000i automated haematology analyser.

作者信息

Ghys T, Malfait R, VAN den Bossche J

机构信息

Clinical Laboratory Middelheim, AZ Middelheim, Lindendreef 1, 2020 Antwerp, Belgium.

出版信息

Int J Lab Hematol. 2009 Oct;31(5):560-6. doi: 10.1111/j.1751-553X.2008.01081.x. Epub 2009 Jun 18.

Abstract

The Sysmex XS-1000i is a compact new, fully automated haematology analyser, designed to generate complete blood counts with five-part leucocyte differential. In our study, a Sysmex XS-1000i instrument was evaluated according to Clinical Laboratory Standards Institute (CLSI) and International Council for Standardization in Haematology (ICSH) guidelines. Precision, carry-over and linearity were determined. Using a total of 700 patient samples, results from the Sysmex XS-1000i were compared with those from a Sysmex XE-2100, an Abbott Cell Dyn 4000 and the manual reference leucocyte differential. Using quality control material, total and within-run imprecision was less than 3% except for platelets. The system demonstrated good linearity over the entire reporting range and no carry-over (<0.5%). The Sysmex XS-1000i showed good correlation with XE-2100, CD-4000 and the manual reference leucocyte differential. Overall flagging sensitivity and specificity were 91% and 48%, respectively. In conclusion, the Sysmex XS-1000i demonstrated good analytical performance, is able to generate a complete blood count with five-part differential on low blood volumes and has considerable back-up capacity.

摘要

希森美康XS-1000i是一款紧凑的新型全自动血液分析仪,旨在进行全血细胞计数并提供五分类白细胞分类结果。在我们的研究中,根据临床实验室标准协会(CLSI)和国际血液学标准化委员会(ICSH)的指南对一台希森美康XS-1000i仪器进行了评估。测定了精密度、携带污染率和线性度。使用总共700份患者样本,将希森美康XS-1000i的结果与希森美康XE-2100、雅培Cell Dyn 4000的结果以及手工参考白细胞分类结果进行了比较。使用质量控制材料,除血小板外,总不精密度和批内不精密度均小于3%。该系统在整个报告范围内显示出良好的线性度,且无携带污染(<0.5%)。希森美康XS-1000i与XE-2100、CD-4000以及手工参考白细胞分类显示出良好的相关性。总体标记敏感性和特异性分别为91%和48%。总之,希森美康XS-1000i表现出良好的分析性能,能够对低血量样本进行全血细胞计数并提供五分类结果,且具有相当大的备用能力。

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