Clinical Laboratory Medicine, Juntendo University Urayasu Hospital, Chiba, Japan.
Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Int J Lab Hematol. 2021 Aug;43(4):588-596. doi: 10.1111/ijlh.13554. Epub 2021 Apr 30.
The erythrocyte sedimentation rate (ESR) is a nonspecific inflammation indicator. In laboratory testing, automated ESR analyzers may use the reference Westergren method (Reference WG), modified Westergren (Modified WG), or Alternate ESR method (Alternate ESR) based on photometric rheology. A prototype hematology analyzer Celltac α+ (Nihon Kohden Corporation) with built-in Novel ESR analysis technology (Novel ESR) was developed to improve the accuracy of Alternate ESR. Alternate ESR uses only the aggregation phase information of Reference WG. The Novel ESR adds sedimentation and packing phase information obtained by hematology analyzer measurands. High correlation with WG was ensured by predicting the ESR value using Hematocrit (Hct) and MCV values as correcting parameters.
Novel ESR was compared with Modified WG (MONITOR-40, Joko Corporation) and Reference WG, according to internationally recognized guidelines: Precision, carryover, limit of quantification, comparability, linearity, accuracy, and fibrinogen sensitivity. Samples from healthy volunteers and clinical patients were used. The correction performance of Novel ESR and Modified WG was compared with Reference WG by regression analysis in three range categories for ESR and measurands affecting ESR correction (Hct, MCV, and MCH).
Novel ESR showed sufficient basic performance and comparability with Modified WG. In the accuracy study comparing with Reference WG, the regression equation was y = 1.026x + 0.5(r = .945,P < .001;n = 271). When evaluating the correction performance, the slopes were within 0.8-1.2, except for the high part of Hct. All intercepts were within 10 mm.
This study validated the correction performance to the initial estimated ESR value by aggregation phase information using information reflecting sedimentation and packing phase obtained from automated hematology analyzer. The Celltac α+ Novel ESR provided results equivalent to Reference WG.
红细胞沉降率（ESR）是一种非特异性炎症指标。在实验室检测中，自动化 ESR 分析仪可能会使用参考 Westergren 法（Reference WG）、改良 Westergren（Modified WG）或替代 ESR 法（Alternate ESR）进行检测，这些方法基于光度流变学原理。为了提高替代 ESR 的准确性，开发了内置新型 ESR 分析技术（Novel ESR）的 Celltac α+（日本光电工业株式会社）原型血液分析仪。替代 ESR 仅使用参考 WG 的聚集相信息。新型 ESR 增加了血液分析仪测量值获得的沉降和堆积相信息。通过将 Hct 和 MCV 值作为校正参数预测 ESR 值，保证了与 WG 的高度相关性。
根据国际公认的指南，将新型 ESR 与改良 Westergren（MONITOR-40，Joko 公司）和参考 Westergren 进行比较：精密度、携带污染、定量限、可比性、线性、准确性和纤维蛋白原敏感性。使用健康志愿者和临床患者的样本。通过回归分析比较新型 ESR 和改良 Westergren 在三个 ESR 校正测量值范围类别和影响 ESR 校正的测量值（Hct、MCV 和 MCH）中的校正性能。
新型 ESR 表现出足够的基本性能和与改良 Westergren 的可比性。在与参考 Westergren 进行准确性研究的比较中，回归方程为 y = 1.026x + 0.5（r =.945，P <.001；n = 271）。在评估校正性能时，斜率在 0.8-1.2 之间，除了 Hct 的高部分。所有截距均在 10mm 以内。
本研究通过使用从自动化血液分析仪获得的反映沉降和堆积相的信息，验证了基于聚集相信息对初始估计 ESR 值的校正性能。Celltac α+新型 ESR 提供的结果与参考 Westergren 相当。
