Walle Muluken, Alemayehu Ermiyas, Tesfaye Addisu, Arkew Mesay, Asmerom Haftu, Agidew Melaku Mekonnen, Getu Fasil
Department of Medical Laboratory Sciences, College of Medicine and Health Sciences, Jigjiga University, Jigjiga, Ethiopia.
Department of Medical Laboratory Sciences, College of Medicine and Health Sciences, Wollo University, Dessie, Ethiopia.
Front Med (Lausanne). 2024 Aug 1;11:1414097. doi: 10.3389/fmed.2024.1414097. eCollection 2024.
Erythrocyte sedimentation rate (ESR) is a widely used screening test in clinical practice as an indicator of inflammatory and degenerative malignant diseases. The Westergren method, renowned as the gold standard, is valued for its accuracy and cost-effectiveness but demands considerable time and blood volume. Emerging automated methods offer quicker and more convenient alternatives, aiming to replace manual techniques. Nonetheless, validating these automated methods against the reference Westergren method is essential to ensure reliability. Therefore, this study aimed to evaluate ESR measurement results obtained from both the reference Westergren method and the automated (SFRI ESR 3000) method.
A Hospital-based comparative cross-sectional study was conducted at Jigjiga University Sheik Hassen Yabare Referral Hospital from July 15 to September 16, 2023. Following the acquisition of informed consent, blood samples were obtained from 158 participants, five milliliters of blood from each participant. These samples were then subjected to ESR estimation using both the Westergren (reference) method and the automated (SFRI ESR 3000) method. Subsequently, the collected data were analyzed using SPSS version 20 and MedCalc version 12.3.0.0 statistical Softwares. Statistical analyses such as Paired -tests, Pearson correlation, linear regression, and the Bland and Altman plot were employed. A -value of < 0.05 was considered statistically significant.
The paired sample -test analysis revealed no significant difference between the use of the reference Westergren method and the automated method for ESR determination, with a mean difference (MD) of 0.7 ± 9.2 mm/h ( = 0.36). Additionally, a significant correlation was observed between the two methods, with a remarkable correlation coefficient ( = 0.94, < 0.001). The Bland-Altman data analysis indicated no evidence of systematic bias and demonstrated good agreement of ESR values between the two methods, with a limit of agreement of -17.3 to +18.7. Moreover, within-run imprecision analysis for the automated method across a range of ESR values showed coefficient of variation of 27.08, 12.65, and 10.32% for low, medium, and high ESR levels, respectively.
The SFRI ESR 300 automated method demonstrates the potential for interchangeable use with the Westergren method for determining ESR, given the strong correlation and good agreement. Additionally, the same reference range could be applied during interpretation.
红细胞沉降率(ESR)是临床实践中广泛使用的一种筛查测试,作为炎症性和退行性恶性疾病的指标。韦斯特格伦法被誉为金标准,因其准确性和成本效益而受到重视,但需要大量时间和血量。新兴的自动化方法提供了更快、更便捷的替代方案,旨在取代手工技术。尽管如此,将这些自动化方法与参考韦斯特格伦法进行验证对于确保可靠性至关重要。因此,本研究旨在评估参考韦斯特格伦法和自动化(SFRI ESR 3000)法获得的ESR测量结果。
2023年7月15日至9月16日,在吉吉加大学谢赫·哈森·亚巴雷转诊医院进行了一项基于医院的比较横断面研究。在获得知情同意后,从158名参与者中采集血样,每名参与者采集5毫升血液。然后使用韦斯特格伦(参考)法和自动化(SFRI ESR 3000)法对这些样本进行ESR估计。随后,使用SPSS 20版和MedCalc 12.3.0.0统计软件对收集的数据进行分析。采用配对t检验、Pearson相关性分析、线性回归分析以及Bland-Altman图等统计分析方法。P值<0.05被认为具有统计学意义。
配对样本t检验分析显示,参考韦斯特格伦法和自动化方法在ESR测定方面无显著差异,平均差异(MD)为0.7±9.2mm/h(P = 0.36)。此外,两种方法之间存在显著相关性,相关系数显著(r = 0.94,P < 0.001)。Bland-Altman数据分析表明没有系统偏差的证据,并且两种方法之间的ESR值具有良好的一致性,一致性界限为-17.3至+18.7。此外,自动化方法在一系列ESR值范围内的批内不精密度分析显示,低、中、高ESR水平的变异系数分别为27.08%、12.65%和10.32%。
鉴于SFRI ESR 300自动化方法与韦斯特格伦法之间具有很强的相关性和良好的一致性,证明了其在测定ESR方面可与韦斯特格伦法互换使用的潜力。此外,在解释过程中可以应用相同的参考范围。