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临床定量方法开发使用LC-MS/MS的血清氧硫酸盐 (IS) 测定方法

Sohei Kobayashi^1,2, Kazuyuki Matsushita², Kenji Kawasaki²

¹Department of Medical Technology & Sciences, School of Health Sciences at Narita, International University of Health and Welfare, Chiba, Japan.

Biochemistry and biophysics reports

|November 10, 2025

概括

硫酸 (IS) 是功能下降的标志物. 这项研究验证了液体染色学-并列质谱法 (LC-MS/MS) 方法用于标准化IS测定,显示出临床使用的优异性能和可重复性.

科学领域:

临床化学临床化学
分析化学分析化学
生物标记分析生物标记分析

背景情况:

硫酸 (IS) 是一种尿素毒素,随着功能下降而积累,加剧病的进展.
目前的IS测试试剂由于缺乏标准测试方法而缺乏标准化.
建立可靠的IS测定对于监测功能和疾病管理至关重要.

研究的目的:

评估液体染色学-并联质谱法 (LC-MS/MS) 的性能,以建立氧硫酸盐 (IS) 的标准检测方法.
评估该方法作为临床环境中IS量化参考标准的适用性.

主要方法:

使用AB SCIEX QTRAP® 4500系统进行LC-MS/MS分析.
方法验证包括线性,可重现性,选择性,干扰测试和LOB,LOD和LLOQ的确定.
通过使用IS的峰值面积与其化内部标准 (IS-d4) 的比率生成一个校准曲线.

主要成果:

通过LC-MS/MS方法证明了极好的线性 (R2=0.9995) 到440μmol/L.
观察到高精度的变化系数为2.6-4.7%的可重复性和7.9-9.2%的中间精度.
该方法显示了高回收 (101.0-104.3%),最小干扰 (<5.0%),并确定了LOB (0.004μmol/L),LOD (1.248μmol/L) 和LOQ (3.23μmol/L).
在LC-MS/MS方法和常规酶分析之间发现了强烈的相关性 (R = 0.996).

结论:

经过验证的LC-MS/MS方法表现出令人满意的基本性能和出色的精度,表明了试验稳定性.
这种方法适用于建立标准化的IS测定.
这些发现支持其作为临床诊断中氧硫酸量化可靠参考方法的实用性.

关键词:

分析验证分析验证慢性病 (CKD) 是一种慢性病.临床定量方法开发临床定量方法开发蛋白质结合的尿性毒素 (PBUT)参考测试方法的参考测试方法.

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