Department of Laboratory Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Division of Laboratory Medicine, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Int J Lab Hematol. 2022 Oct;44(5):846-853. doi: 10.1111/ijlh.13914. Epub 2022 Jun 16.
The Westergren method for erythrocyte sedimentation rate (ESR) measurement has a few drawbacks such as being a time-consuming process, poses a risk of biohazard exposure and requires high sample volume. Recent alternative methods and analyzers were developed to overcome those limitations. In this study, we validated two automated ESR analyzers, MIX-RATE® X20 and VISION A, and assessed their analytical performance against the Westergren method.
The analyzers were validated for inter-run and intra-run precision. Hemolysis interference and sensitivity to fibrinogen were also analysed. Analytical performance was performed using 177 patient samples spanning low (<40 mm/h), medium (40-80 mm/h), and high (>80 mm/h) ESR ranges. Method agreement and bias against the Westergren method were calculated.
The highest intra-run imprecision was seen in the low ESR range for both analyzers. They showed very high agreement with the Westergren method assessed by Spearmen rank correlation coefficient analysis, r = 1.000, p < .0001 for both analyzers. Bland-Altman analysis yielded overall insignificant mean biases for all comparisons. However, systematic positive and negative bias were observed at medium and high ESR levels analysed by MIX-RATE® X20 while negative bias was evidenced in the high ESR level measured by VISION A.
Overall, results from both automated ESR analyzers showed comparable analytical performance with the Westergren method especially for low ESR levels. However, both positive and negative systematic bias were documented in the high levels. Thus, for clinical use, it must be assessed whether these biases could affect the cut-off for significant clinical values.
魏氏血沉（ESR）测定法存在一些缺点，例如耗时、存在生物危害暴露风险且需要高体积的样本。最近开发了一些替代方法和分析仪来克服这些限制。本研究旨在验证两种自动化 ESR 分析仪 MIX-RATE® X20 和 VISION A，并评估它们与魏氏法相比的分析性能。
对两种分析仪进行了批内和批间精密度验证。还分析了溶血干扰和对纤维蛋白原的敏感性。使用涵盖低（<40mm/h）、中（40-80mm/h）和高（>80mm/h）ESR 范围的 177 份患者样本进行分析性能评估。计算了与魏氏法的方法一致性和偏差。
两种分析仪在低 ESR 范围内的批内精密度最高。Spearmen 等级相关系数分析显示，它们与魏氏法具有非常高的一致性，相关系数 r 分别为 1.000 和 1.000（均 p<0.0001）。Bland-Altman 分析显示，所有比较的平均偏差总体上无统计学意义。然而，在 MIX-RATE® X20 分析的中、高 ESR 水平观察到系统的正偏差和负偏差，而在 VISION A 测量的高 ESR 水平则存在负偏差。
两种自动化 ESR 分析仪的结果总体上显示出与魏氏法相当的分析性能，特别是在低 ESR 水平。然而，在高水平上记录了系统的正偏差和负偏差。因此，在临床应用中，必须评估这些偏差是否会影响显著临床值的截止值。
