Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Korea.
Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
J Clin Lab Anal. 2020 Nov;34(11):e23504. doi: 10.1002/jcla.23504. Epub 2020 Aug 9.
Hemoglobin A (HbA) is arguably the most important biomarker used in the diagnosis and treatment monitoring of diabetes mellitus. We evaluated the analytical performance of the Norudia HbA assay (Sekisui Medical Co., LTD), which uses an enzymatic method incorporated into a fully automated, high-throughput system.
The precision, linearity, and carryover of the Norudia HbA assay were evaluated. Using 60 patient samples, comparative analysis of HbA measurements with two commonly used HbA assays, the D100 (Bio-Rad Laboratories, Inc) and HLC-723 G11 (Tosoh), was undergone. Thirteen commutable samples with known HbA concentrations measured using an IFCC reference measurement procedure were used to compare accuracy between methods. Interference of HbA measurement by Hb variants was evaluated using 16 known Hb variant samples.
Repeatability (% CV) for low and high concentrations ranged from 1.12%-1.50% and 0.66%-0.75%, respectively, and within-laboratory precision for low and high concentrations ranged from 1.73%-2.89% and 0.98%-1.64%, respectively. For linearity, the coefficient of determination was 0.9987. No significant carryover was observed. When compared to the D100 and HLC-723 G11 assays, the Norudia HbA assay showed the best accuracy with the lowest mean bias (-1.72%). Furthermore, the Norudia was least affected by Hb variants and gave the most reliable HbA measurements.
The Norudia HbA showed excellent analytical performance with good precision and linearity, and minimal carryover. When compared to other routine HbA methods, the Norudia HbA assay showed the highest accuracy and was least affected by Hb variants.
血红蛋白 A（HbA）可说是在糖尿病的诊断和治疗监测中使用的最重要的生物标志物之一。我们评估了 Norudia HbA 分析（协和发酵麒麟株式会社）的分析性能，该分析使用了一种酶法，结合了全自动、高通量系统。
评估了 Norudia HbA 分析的精密度、线性和携带污染。使用 60 个患者样本，对两种常用的 HbA 分析，即 D100（伯乐公司）和 HLC-723 G11（东曹）的 HbA 测量值进行了比较分析。使用 IFCC 参考测量程序测量已知 HbA 浓度的 13 个可互换样本，以比较方法之间的准确性。使用 16 个已知 Hb 变体样本评估 Hb 变体对 HbA 测量的干扰。
低浓度和高浓度的重复性（%CV）分别为 1.12%-1.50%和 0.66%-0.75%，低浓度和高浓度的实验室内精密度分别为 1.73%-2.89%和 0.98%-1.64%。对于线性，决定系数为 0.9987。未观察到显著的携带污染。与 D100 和 HLC-723 G11 分析相比，Norudia HbA 分析具有最低的平均偏差（-1.72%），显示出最佳的准确性。此外，Norudia 受 Hb 变体的影响最小，给出了最可靠的 HbA 测量值。
Norudia HbA 具有出色的分析性能，具有良好的精密度和线性，最小的携带污染。与其他常规 HbA 方法相比，Norudia HbA 分析显示出最高的准确性，受 Hb 变体的影响最小。
