Evaluation of the Premier Hb9210 instrument for HbA1c determination.

IF 1.3 4区 医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Scandinavian Journal of Clinical & Laboratory Investigation Pub Date : 2023-12-01 Epub Date: 2024-01-24 DOI:10.1080/00365513.2023.2281400
David Núñez-Jurado, Jorge Montenegro-Martínez, Ricardo Rubio-Sánchez, Manuel Conde-Sánchez, Inmaculada Domínguez-Pascual
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Abstract

Background: Glycated hemoglobin measurements are a valuable tool for long-term blood glucose monitoring and the diagnosis of diabetes. Its widespread use has been made possible due to the development of new analytical methods with improved performances and standardization with reference materials. The aim of the present study was to evaluate the Trinity Biotech Premier Hb9210 analyzer for the measurement of HbA1c.Methods: The precision was assessed using the CLSI EP-15A3 and EP-10A3 protocols. The latter was also used to investigate linearity, carryover, and linear drift. The comparison study was performed between Premier Hb910 and Tosoh HLC-723 G8 through Passing-Bablok regression and the Bland-Altman plot. The Fleiss Kappa index was used to assess the degree of agreement. The interference of Hb variants was investigated using samples with Hb variants S, C, D, E, J, and Seville.Results: Within-run and between-run imprecision fell between 0.37% and 1.16%. No statistically significant nonlinearity, carry-over, and/or drift were observed. The resulting regression line of the Passing-Bablok analysis was y = 0.00 + 1.00x. The Pearson correlation coefficient was 0.997. In the Bland-Altman plot, the relative bias was 0.01%. The overall Fleiss Kappa index was 0.9. No interference from hemoglobin variants was observed.Conclusion: The Premier Hb9210 demonstrated a high degree of automation, reproducibility, good agreement, minimal carry-over effect, and excellent linearity across the wide range of HbA1c levels commonly found in diabetic patients and was not influenced by Hb variants.

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Premier Hb9210检测HbA1c仪器的评价
背景:糖化血红蛋白测量是长期血糖监测和糖尿病诊断的重要工具。由于新的分析方法的发展,其性能得到了改善,并与参考物质进行了标准化,因此它的广泛使用成为可能。本研究的目的是评估Trinity Biotech Premier Hb9210分析仪测量HbA1c的效果。方法:采用CLSI EP-15A3和EP-10A3标准进行精密度评估。后者也用于调查线性,结转和线性漂移。通过pass - bablok回归和Bland-Altman图对Premier Hb910与Tosoh HLC-723 G8进行比较研究。采用Fleiss Kappa指数评价一致性程度。使用Hb变异S、C、D、E、J和Seville样本研究Hb变异的干扰。结果:运行内和运行间不精确度在0.37% ~ 1.16%之间。未观察到统计学上显著的非线性、携带和/或漂移。Passing-Bablok分析的回归线为y = 0.00 + 1.00x。Pearson相关系数为0.997。在Bland-Altman图中,相对偏差为0.01%。整体Fleiss Kappa指数为0.9。未观察到血红蛋白变异的干扰。结论:Premier Hb9210在糖尿病患者常见的广泛HbA1c水平范围内表现出高度的自动化、可重复性、良好的一致性、最小的携带效应和良好的线性,并且不受Hb变异的影响。
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来源期刊
CiteScore
3.50
自引率
4.80%
发文量
85
审稿时长
4-8 weeks
期刊介绍: The Scandinavian Journal of Clinical and Laboratory Investigation is an international scientific journal covering clinically oriented biochemical and physiological research. Since the launch of the journal in 1949, it has been a forum for international laboratory medicine, closely related to, and edited by, The Scandinavian Society for Clinical Chemistry. The journal contains peer-reviewed articles, editorials, invited reviews, and short technical notes, as well as several supplements each year. Supplements consist of monographs, and symposium and congress reports covering subjects within clinical chemistry and clinical physiology.
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