该项目的目的是评估血浆LumiPulsep-tau的技术和临床有效性，Aβ42和Aβ40物种及其与CSF核心阿尔茨海默病（AD）标志物的相关性；还进行了与SIMOA的方法比较。一百三十三名参与者，即55A+T+N+AD，28个神经退行性疾病（NDD）和50个对照被纳入研究。Lumipulse技术有效性显示p-tau181，Aβ42和Aβ40的高稳定性，p-tau对重复冻融循环的稳定性更高。与两种NDD/对照相比，两种技术在AD中检测到的p-tau181水平均较高，并且与CSFp-tau水平具有相似的相关性。而两种方法在AD中的Aβ42水平略低。在SIMOA和Lumipulse等离子体标记的比较中，两种技术对p-tau181的AD表现出相似的诊断准确性（0.87;95CI0.81-0.94，vs0.85;95CI0.78-0.93），而p-tau181/Aβ42Lumipulse比率达到最佳性能(ROCAUC0.915,95CI0.86-0.97)。因此，该研究证实了Lumipulse和SIMOA技术在临床环境中鉴定CSFAD模式的构建有效性。
Aim of the project was to evaluate the technical and clinical validity of plasma
Lumipulse p-tau, Aβ42 and Aβ40 species and their correlation with CSF core Alzheimer\'s Disease (AD) markers; a method comparison with SIMOA was also performed. One-hundred-thirthy-three participants, namely 55 A+T+N+ AD, 28 Neurodegenerative disorders (NDD) and 50 controls were enrolled for the study.
Lumipulse technical validity showed high stability for p-tau181, Aβ42, and Aβ40, with higher stability of p-tau to repeated freezing thaw cycles. p-tau181 levels detected by both techniques were higher in AD compared to both NDD/controls and exhibited a similar correlation with CSF p-tau levels, whereas Aβ42 levels were slightly lower in AD with both methods. In the comparison between SIMOA and
Lumipulse plasma markers, both techniques exhibited similar diagnostic accuracy for AD for p-tau181 (0.87; 95 %CI 0.81-0.94, vs 0.85; 95 %CI 0.78-0.93), whereas the best performance was reached by p-tau181/ Aβ42
Lumipulse ratio (ROC AUC 0.915, 95 %CI 0.86-0.97). The study thus confirmed the construct validity of both
Lumipulse and SIMOA techniques for the identification of CSF AD pattern in clinical settings.
