Choe Wonho, Kim Sollip, Chang Jeonghyun, Park Hyunwoong, Kim Ha-Nui, Yoo Soo Jin
Clin Lab. 2020 Nov 1;66(11). doi: 10.7754/Clin.Lab.2020.200107.
The Norudia glycated albumin (GA) assay was evaluated for analytical performance and assay applicability on multiple analytical platforms.
The evaluation included precision, linearity, reference interval, and comparison with Lucica GA assay. A multicenter study was conducted to compare the results of Norudia GA assay on five kinds of widely used automated clinical chemistry analyzers.
Within-laboratory imprecisions for GA% presented 1.3 - 3.3% and 0.8 - 2.6% for low- and high-level control materials, respectively, on different analyzers. GA assay was linear from 20.0 to 680.0 µmol/L of GA. The claimed reference range (12 - 16 GA%) was verified. Norudia GA showed a good GA% correlation with Lucica GA (correlation coefficient 0.999). GA% from each analyzer showed good correlation with the consensus mean of the results of five analyzers (correlation coefficient 0.997 - 0.999).
The Norudia GA assay can successfully be implemented in all the tested platforms, with good GA% correlation.
对诺鲁迪亚糖化白蛋白（GA）检测方法进行了分析性能评估以及在多个分析平台上的检测适用性评估。
评估包括精密度、线性、参考区间以及与露西卡GA检测方法的比较。开展了一项多中心研究，以比较诺鲁迪亚GA检测方法在五种广泛使用的自动临床化学分析仪上的检测结果。
在不同分析仪上，低水平和高水平对照物质的GA%的实验室内不精密度分别为1.3% - 3.3%和0.8% - 2.6%。GA检测方法在20.0至680.0 µmol/L的GA范围内呈线性。所宣称的参考范围（12 - 16 GA%）得到验证。诺鲁迪亚GA与露西卡GA显示出良好的GA%相关性（相关系数0.999）。各分析仪的GA%与五种分析仪结果的一致均值显示出良好的相关性（相关系数0.997 - 0.999）。
诺鲁迪亚GA检测方法能够在所有测试平台上成功实施，具有良好的GA%相关性。
