VES-Matic 5系统:一种测量红细胞沉降率的新型仪器的性能

E. Piva, Alice Stoppa, M. Pelloso, M. Plebani
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引用次数: 2

摘要

VES-Matic 5是一种基于改进的Westergren沉降技术评估红细胞沉降率的自动化分析仪。仪器性能是根据国际血液学标准化理事会的建议确定的。方法对所有样品与参考Westergren法进行比较,并进一步对分析范围的低、中、上三分之一进行比较。进一步评估组内精密度、组间精密度和干扰研究。本研究包括对参考范围的评价。结果采用pass - bablok分析方法进行比较,结果一致,无系统差异和比例差异。回归方程为y= - 0.646 + 0.979x。Bland-Altman分析的平均偏倚为−0.542,上限为8.03,下限为−9.11,可被认为是临床可接受的。每个参数的运行内和运行间精度都很好,干扰研究没有显示出任何显著的偏差,除了贫血样本,在比较高红细胞沉降率值时显示出比例差异。根据临床实验室标准协会(CLSI) EP28-A3C文件,我们利用当地成年参考人群,与文献中可用的参考范围进行了验证。我们确定了按性别和以下年龄组划分的上限:18至50岁、50至70岁和70岁以上。结论VES-Matic 5分析仪与参考方法具有良好的可比性。由于有商业质量控制和合适的外部质量评估(EQA)材料和程序,vesmatic 5可以适当地用于日常目的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The VES-Matic 5 system: performance of a novel instrument for measuring erythrocyte sedimentation rate
Abstract Objectives The VES-Matic 5 is an automated analyzer that assesses erythrocyte sedimentation rate based on a modified Westergren sedimentation technique. Instrument performance was established by addressing the recommendations of the International Council for Standardization in Haematology. Methods Comparison against the reference Westergren method was performed for all samples, and further for the low, middle, and upper third of the analytical range. Intra-run precision, inter‐run precision, and interference studies were further assessed. This study included the evaluation of reference ranges. Results The comparison of methods by Passing–Bablok analysis has shown a good agreement without systematic or proportional differences. The regression equation was y=−0.646 + 0.979x. The mean bias of −0.542 was obtained by Bland–Altman analysis and the upper limit of 8.03 with the lower limit of −9.11 can be considered clinically acceptable. Intra-run and inter-run precision were good for each parameter and interference studies did not show any significant bias with exception of anemia samples, which showed a proportional difference when comparing high erythrocyte sedimentation rate values. Using the local adult reference population, we verified the reference ranges in comparison to those available in the literature, and according to the Clinical Laboratory Standards Institute (CLSI) EP28-A3C document. We determined the upper limit partitioned by gender and the following age groups: from 18 to 50, from 50 to 70, and over 70. Conclusions The VES-Matic 5 analyzer presented good comparability with the reference method. As there are commercial quality control and suitable external quality assessment (EQA) material and programs, the VES-Matic 5 can be employed appropriately for routine purposes.
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