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Diagnostic accuracy of plasma p-tau217/Aβ42 for Alzheimer's disease in clinical and community cohorts

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机构： [1]Department of Neurology and Center for Clinical Neuroscience, Daping Hospital, ThirdMilitaryMedical University, Chongqing, China [2]Chongqing Key Laboratory of Ageing and Brain Diseases, Chongqing, China [3]Institute of Biomedical Engineering, Shenzhen Bay Laboratory, Shenzhen, China [4]Chongqing Institute for Brain and Intelligence, Guangyang Bay Laboratory, Chongqing, China [5]Department of NuclearMedicine, Daping Hospital, ThirdMilitaryMedical University, Chongqing, China [6]Australian eHealth Research Centre, CSIROHealth and Biosecurity, Brisbane,Queensland, Australia [7]Department of Molecular Imaging & Therapy, Austin Health,Melbourne, Victoria, Australia [8]Department of Neurology,West China Hospital of Sichuan University, Chengdu, China [9]Department of Neurology and National Center for Neurological Diseases, Huashan Hospital, State Key Laboratory of Medical Neurobiology and MOE Frontiers Center for Brain Science, Shanghai Medical College, Fudan University, Shanghai, China [10]Department of Neurology & Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, National Center for Neurological Disorders, Beijing, China [11]Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at the University of Gothenburg,Mölndal, Sweden [12]Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden [13]Department of Neurodegenerative Disease, UCL Institute of Neurology,Queen Square, London, UK [14]UK Dementia Research Institute at UCL, London, UK [15]Hong Kong Center for Neurodegenerative Diseases, ClearWater Bay, Hong Kong, China [16]Wisconsin Alzheimer’s Disease Research Center, University of Wisconsin School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin, USA [17]The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville,Melbourne, Victoria, Australia

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关键词： Alzheimer’s disease amyloid positron emission tomography blood biomarker diagnosis Lumipulse p-tau217/Aβ42 two-cutoff approach

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This study was undertaken to evaluate the diagnostic performance of a novel plasma phosphorylated tau (p-tau) 217/amyloid beta (Aβ) 42 ratio test for Alzheimer's disease (AD).The diagnostic performance of the Lumipulse G plasma p-tau217/Aβ42 ratio was evaluated using Aβ and tau positron emission tomography (PET) as reference standards in a clinic cohort (n = 391) and a community cohort (n = 121).Plasma p-tau217/Aβ42 exhibited high performance for abnormal statuses of Aβ PET (area under the curve [AUC]: 0.963 to 0.966) and tau PET (AUC: 0.947 to 0.974), which were clinically equivalent to those of cerebrospinal fluid (CSF) p-tau181/Aβ42 and Aβ42/Aβ40 and higher than those of blood p-tau217, Aβ42/Aβ40, p-tau181, and p-tau181/Aβ42 in both clinic and community cohorts. Applying a two-cutoff approach improved the specificity without reducing sensitivity. The p-tau217/Aβ42 ratio had a lower intermediate percentage than p-tau217 alone in both clinic (10.6% vs 13.0%) and community (16.5% vs 31.4%) cohorts.Plasma p-tau217/Aβ42 has high performance in detecting cerebral AD pathologies, thus offering a promising tool for clinical diagnosis and community screening of AD.Lumipulse G plasma p-tau217 and the p-tau217/Aβ42 ratio accurately identified abnormal Aβ and tau PET statuses in both clinical and community cohorts. The performance of plasma p-tau217 and p-tau217/Aβ42 ratio were equivalent to CSF tests. Plasma p-tau217/Aβ42 ratio outperformed p-tau217 alone in identifying Aβ PET positivity, and this superiority is more obvious in the community cohort, suggesting an advantage in the early diagnosis of AD. Two cut points of p-tau217/Aβ42 were established in the Chinese population for clinical laboratory and community screening uses.© 2025 The Author(s). Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.

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大类 | 1 区

医学

小类 | 1 区临床神经病学

最新[2025]版：

大类 | 1 区

医学

小类 | 1 区临床神经病学

第一作者：

第一作者机构： [1]Department of Neurology and Center for Clinical Neuroscience, Daping Hospital, ThirdMilitaryMedical University, Chongqing, China [2]Chongqing Key Laboratory of Ageing and Brain Diseases, Chongqing, China

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通讯作者：

通讯机构： [1]Department of Neurology and Center for Clinical Neuroscience, Daping Hospital, ThirdMilitaryMedical University, Chongqing, China [2]Chongqing Key Laboratory of Ageing and Brain Diseases, Chongqing, China [4]Chongqing Institute for Brain and Intelligence, Guangyang Bay Laboratory, Chongqing, China

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Diagnostic accuracy of plasma p-tau217/Aβ42 for Alzheimer's disease in clinical and community cohorts

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