The anti-amyloid-β (anti-Aβ) fibrils and soluble oligomers antibody aducanumab were approved to effectively slow down the progression of Alzheimer’s disease (AD) at higher doses in 2019, reaffirming the therapeutic effects of targeting the core pathology of AD. A timely and accurate diagnosis in the prodromal or pre-dementia stage of AD is essential for patient recruitment, stratification, and monitoring of treatment effects. AD core biomarkers amyloid-β (Aβ₁₋₄₂), total tau (t-tau), and phosphorylated tau (p-tau) have been clinically validated to reflect AD-type pathological changes through cerebrospinal fluid (CSF) measurement or positron-emission tomography (PET) and found to have high diagnostic performance for AD identification in the stage of mild cognitive impairment. The development of ultrasensitive immunoassay technology enables AD pathological proteins such as tau and neurofilament light (NFL) to be measured in blood samples. However, combined biomarker detection or targeting multiple biomarkers in immunoassays will increase detection sensitivity and specificity and improve diagnostic accuracy. This review summarizes and analyzes the performance of current detection methods for early diagnosis of AD, and provides a concept of detection method based on multiple biomarkers instead of a single target, which may become a potential tool for early diagnosis of AD in the future.

中文翻译：

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阿尔茨海默病诊断分析中的脑脊液和血液生物标志物

抗淀粉样蛋白——β（抗Aβ) 原纤维和可溶性寡聚体抗体 aducanumab 在 2019 年被批准以更高剂量有效减缓阿尔茨海默病 (AD) 的进展，再次证实了针对 AD 核心病理学的治疗效果。在 AD 的前驱期或痴呆前阶段进行及时准确的诊断对于招募患者、分层和监测治疗效果至关重要。AD核心生物标志物淀粉样蛋白-β（一种β₁₋₄₂)、总 tau (t-tau) 和磷酸化 tau (p-tau) 已通过脑脊液 (CSF) 测量或正电子发射断层扫描 (PET) 进行临床验证，以反映 AD 型病理变化，并发现具有高诊断性轻度认知障碍阶段AD识别的表现。超灵敏免疫分析技术的发展使 AD 病理蛋白如 tau 和神经丝光 (NFL) 能够在血液样本中进行测量。然而，在免疫测定中联合生物标志物检测或靶向多种生物标志物将提高检测灵敏度和特异性，并提高诊断准确性。本综述总结和分析了当前检测方法在 AD 早期诊断中的表现，