Schapkaitz Elise, RabuRabu Shilla, Engelbrecht Marcel
Department of Molecular Medicine and Hematology, Faculty of Health Sciences, University of Witwatersrand Medical School, Johannesburg, South Africa.
Department of Molecular Medicine and Hematology, National Health Laboratory Service, Johannesburg, South Africa.
J Clin Lab Anal. 2019 Feb;33(2):e22661. doi: 10.1002/jcla.22661. Epub 2018 Aug 26.
Worldwide laboratories have adopted the use of modified or alternate methods for measurement of the erythrocyte sedimentation rate (ESR). The iSED from Alcor Scientific is a novel, alternate ESR method based on photometric aggregometry which offers improved operator safety and reduced analysis time. This study evaluated the diagnostic utility of the iSED in a South African patient population with a range of inflammatory disorders.
We compared the iSED with the predicate modified Westergren method (StaRRsed, Mechatronics, Zwaag, the Netherlands) measured at 60 minutes. Analysis was performed on K EDTA samples at three ESR measurement ranges (<20, 20-80 and >80 mm/h) in 120 pediatric and adult inpatients and outpatients over a 2-week period. Precision, stability, and carryover were performed in accordance with the revised International Council for Standardisation in Haematology guidelines.
The iSED demonstrated acceptable imprecision with minimal carryover (2.86%). The correlation coefficients at the 3 ESR measurement ranges were r = 0.58, r = 0.71, and r = 0.56, respectively. The y-intercepts were -10.74 (CI -29.17 to 7.69), -5.95 (CI -18.60 to 6.69) and 246.05 (CI 591.42-99.31). This indicated a difference of a constant nature with an overall mean difference of 7.99 mm/h (CI 5.87-10.13) (P < 0.001). iSED ESR measurements were stable up to 24 hours when stored at room temperature or at 4-8°C.
This study demonstrated differences in ESR results, predominantly at extremes of the analytical range, using an alternate method. Careful consideration and performance monitoring of these novel methods are advised.
全球各实验室已采用改良或替代方法来测量红细胞沉降率(ESR)。Alcor Scientific公司的iSED是一种基于光度凝集法的新型替代ESR检测方法,具有更高的操作安全性并缩短了分析时间。本研究评估了iSED在患有一系列炎症性疾病的南非患者群体中的诊断效用。
我们将iSED与在60分钟时测量的对照改良魏氏法(StaRRsed,Mechatronics,荷兰兹瓦格)进行比较。在两周内,对120名儿科和成人住院患者及门诊患者的K EDTA样本在三个ESR测量范围(<20、20 - 80和>80 mm/h)进行分析。按照修订后的国际血液学标准化委员会指南进行精密度、稳定性和残留检测。
iSED显示出可接受的不精密度,残留极小(2.86%)。在三个ESR测量范围内的相关系数分别为r = 0.58、r = 0.71和r = 0.56。截距分别为-10.74(95%置信区间-29.17至7.69)、-5.95(95%置信区间-18.60至6.69)和246.05(95%置信区间591.42 - 99.31)。这表明存在恒定性质的差异,总体平均差异为7.99 mm/h(95%置信区间5.87 - 10.13)(P < 0.001)。当在室温或4 - 8°C储存时,iSED ESR测量结果在24小时内保持稳定。
本研究表明,使用替代方法时ESR结果存在差异,主要在分析范围的极值处。建议对这些新方法进行仔细考虑和性能监测。