Analytical performance evaluation of hemoglobin A1c on an ARKRAY HA-8160 analyzer with newly-developed mobile phase buffer

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Practical Laboratory Medicine Pub Date : 2024-05-01 DOI:10.1016/j.plabm.2024.e00414

Yuan Yu , Xiaoyun Zhang , Kai Lin

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Abstract

Background

Most glycated hemoglobin A1c (HbA1c) analytical reagents used were obtained from the analyzer's manufacturer. However, clinical laboratories need more choices for HbA1c analytical reagents to overcome the limitations of dedicated reagents for special analyzers. We developed new mobile phase buffers as HbA1c diagnostic reagents and evaluated their analytical performance for the HbA1c assay.

Methods

Different mobile phase buffers used as HbA1c diagnostic reagents were prepared using different concentrations of sodium salts. According to the Clinical and Laboratory Standards Institute (CLSI) recommendation guidelines, the analytical performances of the newly developed mobile phase buffers were evaluated on an ARKRAY HA-8160 Analyzer. Both quality controls and clinical blood samples were used in these experiments. To assess the quality of the newly developed mobile phase buffers, precision, accuracy, linearity, carryover, interference, bias, correlation with commercial reagents, and stability were analyzed.

Results

The CVs of intra-assay precision and interassay precision of quality control and clinical.

There were fewer than 1.00 % blood sample assays using the newly developed mobile phase buffer. The RDs of accuracy were less than 1.00 %. Linearity: R² = 0.9998 in the concentration range of 4.40%–17.30 %. Carryover: 0.00 %. Reagent comparison revealed that the Pearson regression equation was Y = 0.9884x+0.05692 (R² = 0.9977), and the Bland-Altman mean difference was −0.02650 % (CI: −0.2121 %–0.1591 %) between the two analytical reagents. Stability was also acceptable within 12 months. This mobile phase buffer showed good anti-interference ability.

Conclusion

The newly developed mobile phase buffers demonstrated good analytical performance and were suitable for clinical HbA1c assays on an ARKRAY HA-8160 Analyzer.

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使用新开发的流动相缓冲液在 ARKRAY HA-8160 分析仪上进行血红蛋白 A1c 分析性能评估

背景大多数糖化血红蛋白 A1c（HbA1c）分析试剂都是从分析仪制造商那里获得的。然而，临床实验室需要更多的 HbA1c 分析试剂来克服专用分析仪试剂的局限性。我们开发了新的流动相缓冲液作为 HbA1c 诊断试剂，并评估了它们在 HbA1c 检测中的分析性能。根据临床和实验室标准协会（CLSI）的推荐指南，在 ARKRAY HA-8160 分析仪上对新开发的流动相缓冲液的分析性能进行了评估。实验中使用了质量控制和临床血液样本。为了评估新开发的流动相缓冲液的质量，对其精密度、准确度、线性、携带、干扰、偏差、与商业试剂的相关性和稳定性进行了分析。准确度的 RD 小于 1.00%。线性度在 4.40%-17.30 % 的浓度范围内，R2 = 0.9998。迁移率0.00 %.试剂比较显示，两种分析试剂的皮尔逊回归方程为 Y = 0.9884x+0.05692 (R2 = 0.9977)，Bland-Altman 平均差为 -0.02650 % (CI: -0.2121 %-0.1591 %)。12 个月内的稳定性也是可以接受的。结论新开发的流动相缓冲液具有良好的分析性能，适合在 ARKRAY HA-8160 分析仪上进行临床 HbA1c 检测。

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.