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移动相缓冲器的开发和HbA_1c测试的分析性能评估

Yiyao Zhang¹, Guangyun Zhang¹, Fen Yang¹

¹Department of Neurology, Air Force Medical Center, Air Force Medical University, Beijing, China.

Biomedical chromatography : BMC

|August 30, 2025

概括

新的移动相缓冲器用于血红蛋白A1c (HbA1c) 测试显示出出色的分析性能. 这些缓冲器为糖尿病评估提供可靠的结果,符合严格的实验室标准.

科学领域:

临床化学
分析化学
实验室医学

背景情况:

血红蛋白A1c (HbA1c) 对于糖尿病的诊断和监测至关重要.
针对HbA1c测试的移动相缓冲剂的优化研究有限.
标准化的缓冲剂的制备和性能评估对于可靠的血糖控制评估至关重要.

研究的目的:

开发和评估用于HbA1c测量的新型移动相缓冲剂.
根据临床和实验室标准研究所 (CLSI) 的指导方针评估这些新缓冲器的分析性能.
将新开发的缓冲剂的性能与现有的商业配方进行比较.

主要方法:

为HbA1c测试准备新的移动相缓冲剂.
根据CLSI指南进行分析性能评估,包括精度,准确性,线性和延续性.
使用回归和Bland-Altman方法对商业缓冲器进行比较分析.

主要成果:

优异的测试内和测试间精度 (CV<0.94%) 和精度 (RD<3.00%).
没有转移 (0.00%) 和良好的线性 (4.50%-16.80%).
新的缓冲与商业缓冲有很高的相关性 (R2=0.9990) 和可接受的平均差异 (-0.02833%).

结论:

新开发的移动相缓冲器对HbA1c测试具有强大的分析性能.
这些缓冲器具有很高的精度,准确性,线性,最小的延续性和长期稳定性 (24个月).
这些发现支持在临床实验室中使用这些新型缓冲剂进行可靠的HbA1c评估.

关键词:

HbA1c的使用准确性在线性移动相缓冲器准确性

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