在多发性骨髓瘤患者中使用超敏感的向质谱和现成校准仪进行M蛋白诊断
Charissa Wijnands1, Pieter Langerhorst1, Somayya Noori2
1Department of Laboratory Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
Clinical chemistry and laboratory medicine
|October 12, 2023
概括
使用SILuMAB校准器的新方法简化了基于质谱的多发性骨髓瘤最小残留疾病 (MS-MRD) 测试. 这种方法提高了可复制性和成本效益,而不牺牲灵敏度,使MS-MRD更容易获得临床使用.
科学领域:
- 生物化学 生物化学
- 临床化学 临床化学
- 免疫学 免疫学 免疫学
背景情况:
- 最小残留疾病 (MRD) 状态是多发性骨髓瘤的关键预后生物标志物.
- 目前基于个性化质谱仪的MRD (MS-MRD) 提供了敏感的,最少侵入性的监测.
- 量化需要特定于患者的稳定同位素标记 (SIL) ,这是昂贵和耗时的.
研究的目的:
- 引入和验证一种使用现成校准器的简化MS-MRD方法.
- 评估基于SILuMAB的MS-MRD对多发性骨髓瘤的性能.
- 评估SILuMAB作为质量控制工具的潜力.
主要方法:
- 通过将稳定同位素标记的单克隆IgG (SILuMAB-K1) 入患者血清,开发出基于SILuMAB的MS-MRD.
- 通过质谱测量对M蛋白和SILuMAB的丰度进行量化监测.
- 评估了IFM-2009临床试验中的纵向血清的线性,灵敏度和可重现性.
主要成果:
- 在5个日志尺度上实现了线性动态范围,将M蛋白量化到0.001 fg/L.
- 对于基于SILuMAB的MS-MRD,证明了11%的平均测试间变化系数.
- 与基于SIL的MS-MRD显示出极好的一致性 (R2 > 0.985),并确定了用于质量控制的SILuMAB信号.
结论:
- 与SIL酸相比,基于SILuMAB的MS-MRD提高了可复制性,周转时间和成本效益.
- 通过SILuMAB方法,MS-MRD的敏感性和特异性得到维持.
- 在MS-MRD中,SILuMAB是监测样本准备和测试性能的宝贵工具.
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