Khashoggi Haneen, Pignalosa Stefano, Russo Carmelo, Pieri Massimo, Bernardini Sergio
a Department of Experimental Medicine and Surgery , "Tor Vergata" University Hospital , Rome , Italy.
Scand J Clin Lab Invest. 2018 Sep;78(5):393-397. doi: 10.1080/00365513.2018.1487072. Epub 2018 Jul 11.
Glycated hemoglobin (HbA) measurement provides the most important medium to long-term marker of time-averaged glycemic status. Its relationship to clinical outcome in diabetes has been convincingly demonstrated for both type 1 and type 2 diabetes. The main HbA measurement methods for clinical routine are as follows: ion-exchange chromatography; affinity chromatography, capillary electrophoresis, immunoassay and enzymatic methods. In this study, we evaluated the analytical performances of a new HPLC instrument (Tosoh HLC-723 G11 in the VAR mode) in HbA analysis and compared it with a capillary electrophoresis instrument (Sebia Capillarys 2 Flex Piercing). HbA analysis was performed in parallel by both methods for 250 samples randomly chosen from healthy and diabetic subjects at 'Tor Vergata' University Hospital of Rome. Tosoh HLC-723 G11 showed good reproducibility for 10 days both in quality controls and in samples analyzed (%CV < 2%). We found good linearity for HbA1c values ranging from 15 mmol/mol (3.5%) to 178 mmol/mol (18.5%), with a correlation coefficient R = 1. In a comparison between Tosoh HLC-723 G11 and Capillarys 2FP a good correlation (r = 0.99) was found; however, Tosoh HLC-723 G11 showed higher values in the low range of HbA and lower in the high range (Tosoh HLC-723 G11 = 4.3043 + 0.913 Capillarys 2FP; p < 0.001). Tosoh HLC-723 G11 showed good repeatability, reproducibility, accuracy and automated simplicity, and it seemed suitable for routine use in clinical chemistry laboratories.
糖化血红蛋白（HbA）检测提供了反映血糖平均水平的最重要的中长期指标。其与1型和2型糖尿病临床结局之间的关系已得到令人信服的证实。临床常规使用的主要HbA检测方法如下：离子交换色谱法；亲和色谱法、毛细管电泳法、免疫分析法和酶法。在本研究中，我们评估了一台新型高效液相色谱仪（Tosoh HLC-723 G11，可变角度模式）在HbA分析中的分析性能，并将其与一台毛细管电泳仪（Sebia Capillarys 2 Flex Piercing）进行比较。从罗马“托尔韦尔加塔”大学医院的健康受试者和糖尿病患者中随机选取250份样本，用这两种方法并行进行HbA分析。Tosoh HLC-723 G11在质量控制和分析样本中均显示出良好的10天重复性（变异系数%CV＜2%）。我们发现HbA1c值在15 mmol/mol（3.5%）至178 mmol/mol（18.5%）范围内具有良好的线性，相关系数R = 1。在Tosoh HLC-723 G11和Capillarys 2FP的比较中发现良好的相关性（r = 0.99）；然而，Tosoh HLC-723 G11在HbA低水平范围内显示出较高的值，而在高水平范围内显示出较低的值（Tosoh HLC-723 G11 = 4.3043 + 0.913 Capillarys 2FP；p＜0.001）。Tosoh HLC-723 G11显示出良好的重复性、再现性、准确性和自动化简便性，似乎适合临床化学实验室的常规使用。
