Detectability of and interference by major and minor hemoglobin variants using a new-generation ion-exchange HPLC system with two switchable analysis modes

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine Pub Date : 2023-12-09 DOI:10.1016/j.plabm.2023.e00346

Daisuke Manita , Shinji Ogino , Stefaan Marivoet , Masatsune Ogura

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引用次数: 0

Abstract

Objectives

High-performance liquid chromatography (HPLC) is commonly used to measure hemoglobin A_1c (HbA_1c) 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 HbA_1c and detecting Hb-Vars.

Design and methods

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.

Results

Both modes of GR01 had within-laboratory coefficients of variation of ≤1.0 % from four samples with HbA_1c concentrations of 32–86 mmol/mol. Good correlation was observed between GR01 and HLC-723G11. The results for HbA_1c 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)].

Conclusion

The two analysis modes of GR01 were fast and had high accuracy and reproducibility, indicating their utility for routine clinical use in measuring HbA_1c samples with Hb-Vars.

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使用具有两种可切换分析模式的新一代离子交换高效液相色谱系统检测主要血红蛋白变体和次要血红蛋白变体及其干扰情况

目的高效液相色谱 (HPLC) 常用于测量血红蛋白 A1c (HbA1c) 水平和检测血红蛋白变异体 (Hb-Vars)。HLC-723GR01 (GR01) 是新一代自动离子交换 HPLC 系统，具有两种可切换的分析模式，即短模式（30 秒/次）和长模式（50 秒/次）。我们评估了 GR01 两种分析模式在定量 HbA1c 和检测 Hb-Vars 方面的总体性能。在 100 份全血样本中，将 GR01 的两种分析模式与 HLC-723G11 的标准模式进行了比较。在检测常见的 Hb-Vars（HbE、HbD、HbS 和 HbC，共 20 份样本）时，将 GR01 长模式与亲和 HPLC（AF-HPLC）进行了比较。结果从 HbA1c 浓度为 32-86 mmol/mol 的四个样本中，GR01 的两种分析模式在实验室内的变异系数均小于 1.0%。GR01 和 HLC-723G11 之间具有良好的相关性。主要变异体存在时的 HbA1c 检测结果显示，GR01 的长模式与 AF-HPLC 之间具有很强的相关性（r = 0.986-0.998），差异偏差范围为 0.1-1.9 mmol/mol。结论 GR01 的两种分析模式分析速度快、准确度高、重现性好，可用于临床常规 Hb-Vars 测量 HbA1c 样品。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

期刊介绍： Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.