In the last decades, an important role of cerebrospinal fluid (CSF) biomarkers for Alzheimer disease (AD) diagnosis has emerged. The evaluation of the triad consisting of 42 aminoacid-long amyloid-beta peptide (Aβ42), total Tau (tTau) and Tau phosphorylated at threonine 181 (pTau) have been recently integrated into the research diagnostic criteria of AD. For a long time, the enzyme-linked immunosorbent assay (ELISA) has represented the most commonly used method for the measurement of CSF biomarkers levels. This study aimed to assess the diagnostic accuracy of CSF biomarkers, namely Aβ42, tTau and pTau and their ratio, measured by fully automated CLEIA assay (Lumipulse). We included 96 patients clinically diagnosed as AD (48) and non-AD (48). All CSF biomarkers levels were measured on Lumipulse G1200 fully automated platform (Fujirebio Inc. Europe, Gent, Belgium). Aβ42 levels, 42/40 ratio, 42/tTau ratio, 42/PTau ratio were significantly reduced, and tTau and PTau levels were significantly increased in AD patients in comparison with non-AD patients. The receiving operator curve (ROC) analysis showed good diagnostic accuracy of all CSF biomarkers and their ratios for discriminating AD patients from non-AD patients, with 42/40 ratio having the best AUC (0.724, 95%CI 0.619–0.828; p < 0.001). Our findings support the use of CSF biomarkers measured by CLEIA method on a fully automated platform for AD diagnosis.

在过去的几十年中，脑脊髓液（CSF）生物标志物在阿尔茨海默病（AD）诊断中的重要作用已经显现。由42个氨基酸长的淀粉样β肽（Aβ42），总Tau（tTau）和苏氨酸181磷酸化的Tau（pTau）组成的三联体的评估最近已纳入AD的研究诊断标准。长期以来，酶联免疫吸附测定（ELISA）代表了最常用的CSF生物标志物水平测量方法。这项研究旨在评估通过全自动CLEIA分析（Lumipulse）测量的CSF生物标记物Aβ42，tTau和pTau及其比率的诊断准确性。我们纳入了96位临床诊断为AD（48）和非AD（48）的患者。所有CSF生物标志物水平均在Lumipulse G1200全自动平台（Fujirebio Inc. Europe，比利时根特）。与非AD患者相比，AD患者的Aβ42水平，42/40比例，42 / tTau比例，42 / PTau比例显着降低，tTau和PTau水平显着升高。接收操作者曲线（ROC）分析显示，所有CSF生物标志物及其将AD患者与非AD患者区分开的比率均具有良好的诊断准确性，其中42/40的比率具有最佳AUC（0.724，95％CI 0.619-0.828;p  <0.001）。我们的发现支持在完全自动化的AD诊断平台上使用通过CLEIA方法测量的CSF生物标志物。