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Measuring plasma ferritin levels with two different methods: A comparison of Roche Cobas e601 versus Roche Cobas c501 (integrated modular system Roche Cobas 6000).
Journal of Medical Biochemistry ( IF 2.0 ) Pub Date : 2020-01-10 , DOI: 10.2478/jomb-2018-0048
Durmuş Ayan 1 , Sibel Soylemez 2
Affiliation  

BACKGROUND The aim of our study is to compare plasma ferritin levels found to be high or low in terms of reference range by means of electrochemiluminescence (ECLIA) and immunoturbidimetric method and to examine whether they can be used interchangeably. METHODS 84 patients with high plasma ferritin level and 153 patients with low ferritin level according to the re ference range were included in the study. Plasma samples measured in Cobas e601 device with ECLIA were also measured as immunoturbidimetric Cobas c501 device. For method comparison, CLSI EP9-A3 Guideline was used. While the consistency between the methods were specified with Passing-Bablok regression analysis and Spearman cor relation analysis, bias error between the methods (bias%) was determined through Bland-Altman analysis. RESULTS Both high and low plasma ferritin levels measured with Cobas e601 module and determined high in terms of reference range were compared with the results found with cobas c501 module. The difference was found to be statistically significant (p<0.001). According to regression and correlation (for low plasma ferritin levels; r: 0.993, p<0.001, for high plasma ferritin levels; r: 0.966, p<0.001) results, the methods were in consistency with each other. Additionally, while the bias% value was found to be 10.4% for low plasma ferritin levels, it was found to be 12.6% for high ferritin levels. CONCLUSIONS Accordingly, we believe that, comparison with more samples especially in terms of different clinical decision levels is required in order to examine inter changeable use of immunoturbidimetric method in integrated devices and ECLIA.

中文翻译:

用两种不同的方法测量血浆铁蛋白水平:Roche Cobas e601 与 Roche Cobas c501(集成模块化系统 Roche Cobas 6000)的比较。

背景 我们研究的目的是通过电化学发光 (ECLIA) 和免疫比浊法比较参考范围内高或低的血浆铁蛋白水平,并检查它们是否可以互换使用。方法根据参考范围,纳入84例血浆铁蛋白水平高的患者和153例血浆铁蛋白水平低的患者。在具有 ECLIA 的 Cobas e601 设备中测量的血浆样品也作为免疫比浊法 Cobas c501 设备测量。对于方法比较,使用了 CLSI EP9-A3 指南。虽然方法之间的一致性是通过 Passing-Bablok 回归分析和 Spearman 相关分析指定的,但方法之间的偏差误差(偏差%)是通过 Bland-Altman 分析确定的。结果 将使用 Cobas e601 模块测量的高和低血浆铁蛋白水平以及在参考范围方面确定的高水平与使用 cobas c501 模块发现的结果进行了比较。发现差异具有统计学意义 (p<0.001)。根据回归和相关性(对于低血浆铁蛋白水平;r:0.993,p<0.001,对于高血浆铁蛋白水平;r:0.966,p<0.001)结果,这些方法彼此一致。此外,虽然发现低血浆铁蛋白水平的偏倚%值为 10.4%,但高铁蛋白水平的偏倚%值为 12.6%。结论 因此,我们认为,需要与更多样本进行比较,尤其是在不同的临床决策水平方面,以检查免疫比浊法在集成设备和 ECLIA 中的互换使用。
更新日期:2020-01-10
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