Shanghai Diabetes Institute, Shanghai Jiao Tong University Affiliated Sixth People's Hospital; Shanghai Key Laboratory of Diabetes Mellitus, Shanghai, China.
Wuxi Biohermes Bio&Medical Technology Co., Ltd., Wuxi, China.
Biochem Med (Zagreb). 2018 Jun 15;28(2):020705. doi: 10.11613/BM.2018.020705. Epub 2018 Apr 15.
A real world clinical study was designed and conducted to evaluate the performance of a novel point-of-care device for determination of glycated haemoglobin A (HbA), A1C EZ 2.0, in daily clinical practice.
Five hundred and fourteen subjects were included in this study, and divided into three groups. HbA was measured by A1C EZ 2.0 and three different high performance liquid chromatography (HPLC) devices: Bio-Rad Variant II Turbo, Tosoh HLC-723 G8 and Premier Hb9210 separately. Precision of A1C EZ 2.0 was also evaluated.
Results obtained from A1C EZ 2.0 and all HPLC devices are correlated. Passing-Bablok regression analysis shows the equation of A1C EZ 2.0 results against the mean of HPLC devices with corresponding 95% confidence intervals (95% CI) for the intercept and slope is y = 0.10 (- 0.17 to 0.10) + 1.00 (1.00 to 1.04) x. Bland-Altman difference plot shows that the mean relative difference between A1C EZ 2.0 and Variant II Turbo, G8, Hb9210 and all HPLC results is 2.5%, 0.6%, 0.4% and 1.1%, respectively. In addition, 121 pairs of results determined by using both venous and capillary blood prove that the difference of two kinds of blood sample causes no notable variation when measured by A1C EZ 2.0. Precision study gives 2.3% and 1.9% of total coefficient of variation for normal and abnormal HbA sample in A1C EZ 2.0.
HbA values measured by A1C EZ 2.0 were in good accordance with the results obtained with the reference HPLC devices.
设计并开展了一项真实世界的临床研究，以评估新型即时检测设备（用于测定糖化血红蛋白 A1C 的 A1C EZ 2.0）在日常临床实践中的性能。
本研究纳入了 514 名受试者，并将其分为三组。分别使用 A1C EZ 2.0 和三种不同的高效液相色谱（HPLC）设备（Bio-Rad Variant II Turbo、Tosoh HLC-723 G8 和 Premier Hb9210）来测定 HbA。同时还评估了 A1C EZ 2.0 的精密度。
A1C EZ 2.0 与所有 HPLC 设备的测定结果均相关。Passing-Bablok 回归分析显示，A1C EZ 2.0 结果与 HPLC 设备平均值的方程为 y = 0.10（-0.17 至 0.10）+ 1.00（1.00 至 1.04）x，其截距和斜率的 95%置信区间（95%CI）分别为 0.10（-0.17 至 0.10）和 1.00（1.00 至 1.04）。Bland-Altman 差值图显示，A1C EZ 2.0 与 Variant II Turbo、G8、Hb9210 和所有 HPLC 结果的平均相对差值分别为 2.5%、0.6%、0.4%和 1.1%。此外，121 对静脉血和毛细血管血样本的测定结果表明，A1C EZ 2.0 测量两种血液样本时，差异无显著变化。精密度研究表明，A1C EZ 2.0 中正常和异常 HbA 样本的总变异系数分别为 2.3%和 1.9%。
A1C EZ 2.0 测定的 HbA 值与参考 HPLC 设备的结果具有良好的一致性。
