Comparison of the novel Maglumi ferritin immunoluminometric assay with Beckman Coulter DxI 800 ferritin

IF 0.1 Q4 OTORHINOLARYNGOLOGY
M. Dipalo, Cecilia Gnocchi, R. Aloe, G. Lippi
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引用次数: 3

Abstract

Abstract Background: The demand for routine measurement of ferritin is constantly increasing in clinical laboratories due to the clinical value of this biomarker for diagnosing anemia. Therefore, this study was aimed to compare the newly commercialized Maglumi ferritin immunoluminometric assay with a validated commercial and fully automated technique. Methods: The comparison study included 95 consecutive inpatient serum samples referred to the local laboratory for routine ferritin measurement. Serum was separated, divided in two paired aliquots and immediately analyzed with both Beckman Coulter DxI 800 and Maglumi 2000. Correlation was assessed with Deming fit and Spearman’s correlation, the mean bias was estimated with Bland-Altman plot. The concordance between methods was calculated as percentage agreement and κ coefficient. Results: An excellent correlation was observed between Maglumi and DxI (r=0.997). The mean bias was 34 ng/mL and the strength of agreement between values obtained with Maglumi and DxI was 98% and 100% at the lower and upper limits of the reference range. The agreement was also 98% for diagnosing iron deficiency and 94% for diagnosing iron overload. Conclusions: Maglumi immunoassay may be regarded as a suitable alternative for routine and fully-automated assessment of ferritin in clinical laboratories.
新型Maglumi铁蛋白免疫荧光法与Beckman Coulter DxI 800铁蛋白的比较
摘要背景:由于铁蛋白作为一种诊断贫血的生物标志物,临床实验室对铁蛋白常规检测的需求不断增加。因此,本研究旨在比较新商业化的Maglumi铁蛋白免疫荧光测定法与经过验证的商业化全自动技术。方法:将95例连续住院患者血清送交当地实验室常规检测铁蛋白。分离血清,分成两对等分,立即用Beckman Coulter DxI 800和Maglumi 2000进行分析。用Deming拟合和Spearman相关评估相关性,用Bland-Altman图估计平均偏倚。方法间的一致性以一致性百分比和κ系数计算。结果:Maglumi与DxI呈极好的相关性(r=0.997)。平均偏差为34 ng/mL,在参考范围的下限和上限上,Maglumi和DxI获得的值的一致性强度分别为98%和100%。诊断缺铁和铁超载的准确率分别为98%和94%。结论:Maglumi免疫分析法可作为临床实验室常规全自动检测铁蛋白的合适替代方法。
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来源期刊
CiteScore
0.80
自引率
0.00%
发文量
1
审稿时长
>12 weeks
期刊介绍: Information not localized
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