通过使用新一代离子交换HPLC系统和两种可切换分析模式的新一代离子交换HPLC系统检测和干扰主要和次要血红蛋白变异
Daisuke Manita1, Shinji Ogino1, Stefaan Marivoet2
1Bioscience Division, Tosoh Corporation, Japan.
Practical laboratory medicine
|December 15, 2023
概括
新的HLC-723GR01 (GR01) HPLC系统为血红蛋白A1c (HbA1c) 和血红蛋白变体 (Hb-Vars) 提供快速而准确的测量. 短和长分析模式都显示出高精度和可复制性,用于临床使用.
科学领域:
- 临床化学 临床化学
- 分析化学 分析化学
- 血液学 血液学 血液学
背景情况:
- 高性能液体染色学 (HPLC) 是量化血红蛋白A1c (HbA1c) 和检测血红蛋白变体 (Hb-Vars) 的标准.
- HLC-723GR01 (GR01) 是一种自动化的离子交换HPLC系统,设计具有两个可切换的分析模式:短模式 (30秒/测试) 和长模式 (50秒/测试).
研究的目的:
- 评估HLC-723GR01 (GR01) 系统的短分析模式和长分析模式的一般性能.
- 评估GR01系统在量化HbA1c水平和检测Hb-Vars.的能力.
主要方法:
- 使用CLSI协议EP-05-A3.3评估仪器精度.
- 将GR01系统的两种模式与HLC-723G11标准模式进行比较,使用100个全血样本进行HbA1c定量.
- 长模式的GR01与 afinity HPLC (AF-HPLC) 进行了比较,用于检测常见的Hb-Vars (HbE,HbD,HbS,HbC),并且在多个分析仪上分析了小的Hb-Vars.
主要成果:
- 两种GR01模式的实验室内变化系数为≤1.0%,HbA1c度在32-86mmol/mol之间.
- 在GR01和HLC-723G11之间观察到强烈的相关性,用于HbA1c测量,并在GR01长模式和AF-HPLC之间检测Hb-Vars (r = 0.986-0.998).
- 在主要变异存在时,HbA1c检测的差异偏差很低 (0.1-1.9 mmol/mol),只有一个小变异在长模式下显示偏差超过14%.
结论:
- HLC-723GR01系统在短时间和长时间分析模式下,为HbA1c测量和Hb-Var检测提供快速,准确和可重复的结果.
- GR01系统适用于日常临床实验室使用,用于管理糖尿病和血红蛋白病变患者.
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