Abstract

The erythrocyte sedimentation rate (ESR) has been commonly ordered in hematology laboratories and used to screen for monitoring responses to therapy and identifying inflammatory conditions. To overcome the limitations of traditional ESR measurements, various methods have been developed and compared to the established reference method. This study evaluates the analytical performance of ESR fast detector and Improve^® ESR analyzer compared to the reference method. Method validation and comparison were performed in 189 volunteer blood samples according to the International Council for Standardization in Hematology recommendations. The analytical efficacy of ESR fast detector and Improve^® ESR analyzer was also assessed and compared with the reference method and C-reactive protein (CRP) levels. The results demonstrated that the precision of ESR fast detector and Improve^® ESR analyzer was considered as the acceptance criterion for the ESR measurement. The method comparison analysis between the two modified Westergren methods and reference method demonstrated a strong correlation with the Spearman’s rank correlation coefficient of 0.94, with a mean difference of −2.1 and −7.7 mm/h in the ESR fast detector and Improve^® ESR analyzer, respectively. Analysis of the area under the receiver operating curve illustrated a high analytical performance compared to the reference method and CRP level. The measurement of ESR level using the ESR fast detector and Improve^® ESR analyzer is a reliable method and has a high analytical performance, which can be used instead of the reference method for screening inflammatory conditions.

摘要

红细胞沉降率 (ESR) 通常在血液学实验室中订购，并用于筛选以监测对治疗的反应和识别炎症状况。为了克服传统 ESR 测量的局限性，开发了各种方法并将其与已建立的参考方法进行比较。本研究评估了 ESR 快速检测器和 Improve ^® ESR 分析仪与参考方法相比的分析性能。根据国际血液学标准化委员会的建议，对 189 份志愿者血液样本进行了方法验证和比较。^{ESR 快速检测器和Improve®}的分析功效还对 ESR 分析仪进行了评估，并与参考方法和 C 反应蛋白 (CRP) 水平进行了比较。结果表明，ESR 快速检测器和 Improve ^® ESR 分析仪的精度被认为是 ESR 测量的验收标准。^{两种改进的 Westergren 方法和参考方法之间的方法比较分析表明，在 ESR 快速检测器和 Improve ®} ESR 分析仪中，Spearman 等级相关系数为 0.94，平均差异为 -2.1 和 -7.7 mm/h ，分别。与参考方法和 CRP 水平相比，接受者操作曲线下面积的分析说明了较高的分析性能。使用 ESR 快速检测器和 Improve ^{®测量 ESR 水平}ESR分析仪是一种可靠的方法，具有较高的分析性能，可替代参考方法筛查炎症。