Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy; Department of continuity of care and frailty, Neurology Unit, ASST Spedali Civili Hospital, Brescia, Italy; Residency Program in Clinical Pathology and Clinical Biochemistry, Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy; Neurobiorepository and Laboratory of advanced biological markers, University of Brescia and ASST Spedali Civili Hospital, Brescia, Italy; A. Nocivelli Institute for Molecular Medicine Spedali Civili Hospital and Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.
Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy; Department of continuity of care and frailty, Neurology Unit, ASST Spedali Civili Hospital, Brescia, Italy; Neurobiorepository and Laboratory of advanced biological markers, University of Brescia and ASST Spedali Civili Hospital, Brescia, Italy.
Neurobiol Aging. 2024 Nov;143:30-40. doi: 10.1016/j.neurobiolaging.2024.08.007. Epub 2024 Aug 22.
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.
本研究旨在评估 Lumipulse 血浆 p-tau、Aβ42 和 Aβ40 同种型的技术和临床有效性，及其与 CSF 核心阿尔茨海默病（AD）标志物的相关性；同时也与 SIMOA 进行了方法比较。共纳入 133 名参与者，包括 55 名 A+T+N+AD、28 名神经退行性疾病（NDD）和 50 名对照者。Lumipulse 技术有效性显示 p-tau181、Aβ42 和 Aβ40 的稳定性较高，p-tau 对反复冻融循环的稳定性更高。与 NDD/对照组相比，两种技术检测到的 AD 患者 p-tau181 水平均较高，且与 CSF p-tau 水平呈相似相关性，而两种方法检测到的 AD 患者 Aβ42 水平均略低。在 SIMOA 和 Lumipulse 血浆标志物之间的比较中，两种技术检测 p-tau181 对 AD 的诊断准确性相似（0.87；95%CI 0.81-0.94，vs 0.85；95%CI 0.78-0.93），而 p-tau181/Aβ42 Lumipulse 比值的性能最佳（ROC AUC 0.915，95%CI 0.86-0.97）。因此，本研究证实了 Lumipulse 和 SIMOA 技术在临床环境中识别 CSF AD 模式的结构有效性。
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