Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy.
Department of Medicine - DIMED, University of Padova, Padova, Italy.
Clin Chem Lab Med. 2022 May 11;60(7):1081-1090. doi: 10.1515/cclm-2022-0359. Print 2022 Jun 27.
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.
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.
The comparison of methods by Passing-Bablok analysis has shown a good agreement without systematic or proportional differences. The regression equation was =-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.
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.
VES-Matic 5 是一种自动分析仪，基于改良 Westergren 沉降技术评估红细胞沉降率。仪器性能通过满足国际血液学标准化委员会的建议来建立。
对所有样本进行与参考 Westergren 方法的比较，并对分析范围内的低、中、高三部分进一步进行比较。还进一步评估了批内精密度、批间精密度和干扰研究。本研究包括参考范围的评估。
通过 Passing-Bablok 分析对方法进行比较，结果显示无系统或比例差异的良好一致性。回归方程为=-0.646+0.979x。Bland-Altman 分析得出的平均偏差为-0.542，上限为 8.03，下限为-9.11，可以认为临床可接受。每个参数的批内和批间精密度都很好，除贫血样本外，干扰研究没有显示任何显著偏差，当比较高红细胞沉降率值时，贫血样本显示出比例差异。使用当地成人参考人群，我们将参考范围与文献中的参考范围进行了比较，并根据临床实验室标准化协会（CLSI）EP28-A3C 文件进行了比较。我们根据性别和以下年龄组确定了上限分区：18-50 岁、50-70 岁和 70 岁以上。
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，因此可以适当地将 VES-Matic 5 用于常规目的。
