Lorubbio Maria, Diamanti Daniela, Pieroni Carolina, Gialli Elena, Pettinari Massimiliano, Bassi Stefania, Gorini Gabriele, Carniani Stefania, Saracini Alessandro, Meloni Paola, Chiodi Michela, Gervino Silvana, Pantone Pietro, Ognibene Agostino
UOC Laboratory Medicine, Department of Laboratory Medicine and Transfusion, San Donato Hospital, 52100 Arezzo, Italy.
Diesse-Diagnostica Senese S.p.A., 53035 Monteriggioni, Italy.
Diagnostics (Basel). 2025 Apr 26;15(9):1101. doi: 10.3390/diagnostics15091101.
: The erythrocyte sedimentation rate (ESR) is a diagnostic test that is employed worldwide to assess a patient's inflammatory status. Like all laboratory tests, it requires reference intervals (RIs) to support clinical decision making and facilitate accurate diagnosis. In this study, we aimed to generate RIs for the automatic analyzers VES-MATIC 5 (VM5) and CUBE 30 touch (C30T) compared to the gold standard method. : A total of 989 (presumably healthy) participants from Arezzo Hospital in Italy were enrolled. The ESR RIs were established according to CLSI for all three methods. : The analysis pointed out significant differences between women and men and age-related increases in ESRs obtained via all three analytical methods. The average and median values resulting from VM5 and C30T were, respectively, 1 mm/h smaller and higher than the gold standard. The RIs were calculated based on three clusters: the first pertained to patients aged ≥ 18 but ≤ 49 years; the second pertained to patients aged ≥ 50 but ≤ 69 years; the last comprised patients aged ≥ 70 years. Due to the clear overlap between these ranges and the statistical analysis, we identified only one range for females ≥ 18 years (Westergren: 1-22 mm/h; VM5: 1-22 mm/h; C30T: 1-25 mm/h). For the male participants, two separate RIs were proposed: one for those aged ≥ 18 but < 69 years (Westergren: 1-14 mm/h; VM5: 1-14 mm/h; C30T: 1-18 mm/h) and one for those aged 70 years or above (Westergren: 1-22 mm/h; VM5: 1-23 mm/h; C30T: 1-29 mm/h). : The proposed RI for automated analyzers C30T and VM5 agreed with the reference method and can be adopted to measure ESRs within EDTA blood samples.
红细胞沉降率(ESR)是一项在全球范围内用于评估患者炎症状态的诊断测试。与所有实验室检测一样,它需要参考区间(RIs)来支持临床决策并促进准确诊断。在本研究中,我们旨在生成自动分析仪VES-MATIC 5(VM5)和CUBE 30 touch(C30T)相对于金标准方法的参考区间。:总共招募了来自意大利阿雷佐医院的989名(假定健康的)参与者。根据CLSI为所有三种方法建立了ESR参考区间。:分析指出,通过所有三种分析方法获得的ESR在女性和男性之间存在显著差异,并且与年龄相关的ESR升高。VM5和C30T得出的平均值和中位数分别比金标准小1毫米/小时和高1毫米/小时。参考区间基于三个类别计算:第一个类别适用于年龄≥18岁但≤49岁的患者;第二个类别适用于年龄≥50岁但≤69岁的患者;最后一个类别包括年龄≥70岁的患者。由于这些范围之间存在明显重叠以及统计分析,我们仅确定了≥18岁女性的一个范围(魏氏法:1 - 22毫米/小时;VM5:1 - 22毫米/小时;C30T:1 - 25毫米/小时)。对于男性参与者,提出了两个单独的参考区间:一个适用于年龄≥18岁但<69岁的男性(魏氏法:1 - 14毫米/小时;VM5:1 - 14毫米/小时;C30T:1 - 18毫米/小时),另一个适用于年龄70岁及以上的男性(魏氏法:1 - 22毫米/小时;VM5:1 - 23毫米/小时;C30T:1 - 29毫米/小时)。:为自动分析仪C30T和VM5提出的参考区间与参考方法一致,可用于测量EDTA血样中的ESR。