建立和应用基于ICP-MS的双免疫测试方法,用于标记稳定元素抗体
Xuyao Ji1, Jing Wu1, Jing Zhang1
1Department of Laboratory Medicine at the Fourth Affiliated Hospital, Harbin Medical University, Harbin, China.
Journal of clinical laboratory analysis
|December 31, 2024
概括
使用诱导合血质谱法 (ICP-MS) 的新型双免疫试验可以同时检测α-fetoprotein (AFP) 和前列腺特异性抗原 (PSA). 这种经过验证的方法显示了临床血清样本的高精度和特异性.
科学领域:
- 分析化学 分析化学
- 生物化学 生化学
- 临床诊断 临床诊断 临床诊断
背景情况:
- 开发一种双重免疫试验,同时检测血清中的α-fetoprotein (AFP) 和前列腺特异性抗原 (PSA).
- 使用感应合等离子体质谱法 (ICP-MS) 与稳定元素标记抗体.
研究的目的:
- 建立和评估一种新的AFP和PSA双重免疫试验.
- 为了验证基于ICP-MS的方法的性能和临床适用性.
主要方法:
- 通过使用磁珠和稀土元素标签 (Europium和Samarium) 建立了双抗体三明治免疫试验.
- 优化了测试条件,并根据CLSI指南进行了性能验证.
- 使用临床血清样本验证了该方法.
主要成果:
- 达到了AFP (0.76 ng/mL) 和PSA (0.41 ng/mL) 的低检测极限 (LOD).
- 在两种分析物中都表现出优异的批量内 (<3.33%) 和批量间 (<4.97%) 精度.
- 与CLIA方法相比,报告了较高的相关系数 (r=0.9930对于AFP,r=0.9852对于PSA).
结论:
- 成功开发了一种基于ICP-MS的双免疫试验,用于同时检测血清中的AFP和PSA.
- 该方法具有良好的精度,宽线性范围和高特异性,满足临床要求.
- 开发的试验显示出在诊断中临床应用的巨大潜力.
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