用于肝纤维化诊断和监测的血清Mac-2结合蛋白糖基化异构体检测的评估以及Mac-2结合蛋白糖基化异构体与糖化血红蛋白的相关性
Evaluation of the Serum Mac-2 Binding Protein Glycosylation Isomer Test used for Diagnosis and Monitoring of Liver Fibrosis and the Correlation of Mac-2 Binding Protein Glycosylation Isomer with Hemoglobin A1c.
作者信息
Choi Rihwa, Oh Youngju, Lee Sukjung, Lee Sang Gon
出版信息
Clin Lab. 2019 Jan 1;65(1). doi: 10.7754/Clin.Lab.2018.180719.
BACKGROUND
Our aims in this study were to evaluate the performance of the Mac-2 binding protein glycosylation isomer (M2BPGi), a liver fibrosis marker, using Sysmex HISCL following user verification guidelines before clinical use. We also evaluated the correlation between M2BPGi and hemoglobin A1c (HbA1c) because HbA1c is known as another biomarker associated with glycosylation.
METHODS
The analytical performance of M2BPGi was verified following user verification guidelines by the Clinical and Laboratory Standards Institute.
RESULTS
A qualitative, precision experiment for analyte concentrations near the cutoff was verified using quality control materials. The manufacturer's precision claims for the quantitative cutoff index were verified, with coefficients of variation in the range of 1.83 - 4.12%. HbA1c did not significantly contribute to M2BPGi in a multivariate analysis with an age factor.
CONCLUSIONS
The analytical performance of M2BPGi in our results verify the manufacturer's claims. Clinical information and other findings, including HbA1c, are needed for clinical applications.
背景
本研究的目的是在临床使用前，按照用户验证指南，评估Sysmex HISCL检测肝纤维化标志物Mac-2结合蛋白糖基化异构体（M2BPGi）的性能。我们还评估了M2BPGi与糖化血红蛋白（HbA1c）之间的相关性，因为HbA1c是另一种已知的与糖基化相关的生物标志物。
方法
按照临床和实验室标准协会的用户验证指南对M2BPGi的分析性能进行验证。
结果
使用质控材料验证了接近临界值的分析物浓度的定性、精密度实验。验证了制造商对定量临界值指数的精密度声明，变异系数在1.83 - 4.12%范围内。在包含年龄因素的多变量分析中，HbA1c对M2BPGi没有显著影响。
结论
我们结果中M2BPGi的分析性能验证了制造商的声明。临床应用需要临床信息和包括HbA1c在内的其他结果。
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