Tomassetti Flaminia, Calabrese Cinzia, Bertani Fabio, Cennamo Michele, Diamanti Daniela, Giovannelli Alfredo, Guerranti Roberto, Leoncini Roberto, Lorubbio Maria, Ognibene Agostino, Nicolai Eleonora, Pelagalli Martina, Pieroni Carolina, Bernardini Sergio, Pieri Massimo
Department of Experimental Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy.
Department of Laboratory Medicine, Tor Vergata University Hospital, Viale Oxford 81, 00133 Rome, Italy.
Diagnostics (Basel). 2024 Sep 11;14(18):2011. doi: 10.3390/diagnostics14182011.
Erythrocyte Sedimentation Rate (ESR) is an easy test used to diagnose and monitor inflammatory and infectious diseases. The aim of this study was the evaluation of the performance of three ESR automated analyzers, VES-MATIC 5, CUBE 30 TOUCH, and MINI-CUBE, involving four Italian polyclinics in Rome, Siena, Como, and Arezzo, as well as inter-site variability assessment to detect possible device-dependent and operator-dependent influences.
Accuracy analysis was carried out by analyzing the same samples with all three instruments and comparing them with the Westergren method. Precision was assessed with quality control material through intra-run and inter-run precision. Repeatability was estimated by reanalyzing fresh blood samples belonging to three ESR ranges (low, intermediate, and high) six times.
The results showed a strong correlation (Spearman coefficients R) between the manual method and VES-MATIC 5 (0.978), CUBE 30 TOUCH (0.981), and MINI-CUBE (0.974). The accuracy of all clinics was excellent, with coefficients of variation (CVs) of less than 10% for all instruments. Repeatability confirmed an excellent level for all ESR ranges, with CVs below 10%.
The study proved that all three automated instruments offer optimal performance for accuracy and precision and are suitable for both large and small facilities without influences of the laboratory environment.
红细胞沉降率（ESR）是一种用于诊断和监测炎症及感染性疾病的简易检测方法。本研究的目的是评估三种ESR自动分析仪VES-MATIC 5、CUBE 30 TOUCH和MINI-CUBE的性能，涉及罗马、锡耶纳、科莫和阿雷佐的四家意大利综合诊所，并进行站点间变异性评估，以检测可能的设备依赖性和操作员依赖性影响。
通过用所有三种仪器分析相同样本并与魏氏法进行比较来进行准确性分析。通过批内和批间精密度用质量控制材料评估精密度。通过对属于三个ESR范围（低、中、高）的新鲜血液样本进行六次重新分析来估计重复性。
结果显示手动方法与VES-MATIC 5（Spearman系数R为0.978）、CUBE 30 TOUCH（0.981）和MINI-CUBE（0.974）之间有很强的相关性。所有诊所的准确性都非常好，所有仪器的变异系数（CV）均小于10%。重复性证实了所有ESR范围的水平都非常好，CV低于10%。
该研究证明，所有三种自动化仪器在准确性和精密度方面都具有最佳性能，适用于大小型机构，不受实验室环境的影响。
