生物标志物 生物标志物
Ashvini Keshavan1, Katharine Wiltshire2, Melanie Hart3,4
1Dementia Research Centre, UCL Queen Square Institute of Neurology, University College London, London, United Kingdom.
Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 24, 2025
概括
血p-tau217测定显示了对阿尔茨海默病 (AD) 诊断的高准确性. 与ALZpath相比,Lumipulse试验显示出更高的负预测值,支持其在临床试验中的使用.
科学领域:
- 神经学 神经学
- 生物标志物发现发现
- 临床诊断 临床诊断 临床诊断
背景情况:
- ADAPT研究调查了血p-tau217对阿尔茨海默病 (AD) 诊断和结果的影响.
- 第1阶段验证的p-tau217测定针对脑脊液 (CSF) 的AD生物标志物和粉样蛋白PET状态.
研究的目的:
- 为了验证两个商业血p-tau217试验 (Lumipulse和ALZpath) 与CSFAD生物标志物相对应.
- 为了推导和评估血p-tau217测定的临床切割点.
- 在独立的粉样蛋白PET队列中评估测试性能.
主要方法:
- 来自脊髓和粉样蛋白PET队伍的血样本使用Lumipulse和ALZpath测试进行了测试.
- 95%的敏感度和特异性的切割点来自CSF队列.
- 在两个队列中评估了测试性能指标,包括中间结果,NPV和PPV.
主要成果:
- 在CSF队列 (n=257) 中,Lumipulse切割点产生了91%的NPV和96%的PPV.
- 粉样蛋白PET队列 (n=76) 显示Lumipulse切割点产生了89%的NPV和91%的PPV.
- 在两个队列中,Lumipulse的NPV比ALZpath更高,中间结果为19-34%.
结论:
- 光脉冲血p-tau217测定精度在两个队列中高/低值超过90%.
- 与ALZpath.path相比,Lumipulse显示出更高的NPV.
- 已验证的Lumipulse切割点将用于随机对照试验,以披露结果.
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