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Abstract：
UNASSIGNED: High-performance liquid chromatography (HPLC) is commonly used to measure hemoglobin A1c (HbA1c) levels and detect hemoglobin variants (Hb-Vars). HLC-723GR01 (GR01) is a new-generation automated ion-exchange HPLC system with two switchable analysis modes, namely short (30 s/test) and long modes (50 s/test). We evaluated the general performance of both analysis modes of GR01 for quantifying HbA1c and detecting Hb-Vars.
UNASSIGNED: We evaluated the instrument\'s precision based on CLSI protocol EP-05-A3. A comparison of the two analysis modes of GR01 against the standard mode of HLC-723G11 was performed on 100 whole blood samples. The GR01 long mode was compared with affinity HPLC (AF-HPLC) for detecting common Hb-Vars (HbE, HbD, HbS, and HbC, >20 samples). To examine the detection capability for minor Hb-Vars, we analyzed 26 Hb-Vars using multiple analyzers, including both analysis modes of GR01.
UNASSIGNED: Both modes of GR01 had within-laboratory coefficients of variation of ≤1.0 % from four samples with HbA1c concentrations of 32-86 mmol/mol. Good correlation was observed between GR01 and HLC-723G11. The results for HbA1c detection in the presence of the major variants revealed a strong correlation between the long mode of GR01 and AF-HPLC (r = 0.986-0.998), and the difference biases ranged 0.1-1.9 mmol/mol. In the long mode, only one variant had a difference bias exceeding 14 % [10 % (%NGSP)].
UNASSIGNED: The two analysis modes of GR01 were fast and had high accuracy and reproducibility, indicating their utility for routine clinical use in measuring HbA1c samples with Hb-Vars.
UNASSIGNED: We evaluated the instrument\'s precision based on CLSI protocol EP-05-A3. A comparison of the two analysis modes of GR01 against the standard mode of HLC-723G11 was performed on 100 whole blood samples. The GR01 long mode was compared with affinity HPLC (AF-HPLC) for detecting common Hb-Vars (HbE, HbD, HbS, and HbC, >20 samples). To examine the detection capability for minor Hb-Vars, we analyzed 26 Hb-Vars using multiple analyzers, including both analysis modes of GR01.
UNASSIGNED: Both modes of GR01 had within-laboratory coefficients of variation of ≤1.0 % from four samples with HbA1c concentrations of 32-86 mmol/mol. Good correlation was observed between GR01 and HLC-723G11. The results for HbA1c detection in the presence of the major variants revealed a strong correlation between the long mode of GR01 and AF-HPLC (r = 0.986-0.998), and the difference biases ranged 0.1-1.9 mmol/mol. In the long mode, only one variant had a difference bias exceeding 14 % [10 % (%NGSP)].
UNASSIGNED: The two analysis modes of GR01 were fast and had high accuracy and reproducibility, indicating their utility for routine clinical use in measuring HbA1c samples with Hb-Vars.
摘要：
■高效液相色谱（HPLC）通常用于测量血红蛋白A1c（HbA1c）水平并检测血红蛋白变体（Hb-Vars）。HLC-723GR01(GR01)是新一代自动化离子交换HPLC系统，具有两种可切换的分析模式，即短模式(30秒/测试)和长模式(50秒/测试)。我们评估了GR01两种分析模式用于定量HbA1c和检测Hb-Vars的一般性能。
■我们根据CLSI协议EP-05-A3评估了仪器的精度。对100个全血样品进行GR01的两种分析模式与HLC-723G11的标准模式的比较。将GR01长模式与亲和HPLC（AF-HPLC）进行比较，以检测常见的Hb-Vars（HbE，HBD,HBS,HbC,>20个样品)。为了检查次要Hb-Vars的检测能力，我们使用多个分析仪分析了26个Hb-Vars，包括GR01的两种分析模式。
■GR01的两种模式均具有来自HbA1c浓度为32-86mmol/mol的四个样品的实验室内变异系数≤1.0%。在GR01和HLC-723G11之间观察到良好的相关性。在存在主要变体的情况下检测HbA1c的结果揭示了GR01的长模式与AF-HPLC之间的强相关性（r=0.986-0.998），差异偏差为0.1-1.9mmol/mol。在长模式下，只有一个变异体的差异偏差超过14%[10%(%NGSP)].
■GR01的两种分析模式快速，具有较高的准确性和重现性，表明它们在用Hb-Vars测量HbA1c样品中的常规临床用途。
■我们根据CLSI协议EP-05-A3评估了仪器的精度。对100个全血样品进行GR01的两种分析模式与HLC-723G11的标准模式的比较。将GR01长模式与亲和HPLC（AF-HPLC）进行比较，以检测常见的Hb-Vars（HbE，HBD,HBS,HbC,>20个样品)。为了检查次要Hb-Vars的检测能力，我们使用多个分析仪分析了26个Hb-Vars，包括GR01的两种分析模式。
■GR01的两种模式均具有来自HbA1c浓度为32-86mmol/mol的四个样品的实验室内变异系数≤1.0%。在GR01和HLC-723G11之间观察到良好的相关性。在存在主要变体的情况下检测HbA1c的结果揭示了GR01的长模式与AF-HPLC之间的强相关性（r=0.986-0.998），差异偏差为0.1-1.9mmol/mol。在长模式下，只有一个变异体的差异偏差超过14%[10%(%NGSP)].
■GR01的两种分析模式快速，具有较高的准确性和重现性，表明它们在用Hb-Vars测量HbA1c样品中的常规临床用途。
