ArticleAlzheimer's research & therapy2022
Fully automated and highly specific plasma β-amyloid immunoassays predict β-amyloid status defined by amyloid positron emission tomography with high accuracy.
Article in Alzheimer's research & therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.
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Who cites it
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Blood-based biomarkers for detecting Alzheimer's disease pathology in cognitively impaired individuals within specialized care settings: A systematic review and meta-analysis.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Pooled it
- Alzheimer's Association Clinical Practice Guideline on the use of blood-based biomarkers in the diagnostic workup of suspected Alzheimer's disease within specialized care settings.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Guideline
- Diagnostic Performance and Clinical Utility of Automated Plasma Amyloid-β 1-42/1-40 Assay.Diagnostics (Basel, Switzerland) · 2026Article
- Potential diagnostic markers in Alzheimer's disease: current perspectives and future directions.Neurodegenerative disease management · 2026Review
- Blood-based biomarkers of Alzheimer's disease: potential utility in clinical practice.Current opinion in neurology · 2026Review
- Circulating Biomarkers for the Early Diagnosis of Alzheimer's Disease.International journal of molecular sciences · 2025Review
- Plasma biomarkers for early detection of alzheimer's disease: a cross-sectional study in a Japanese cohort.Alzheimer's research & therapy · 2025Article
- Development of amyloid β (1-42) certified reference material NMIJ CRM 6210-a.Analytical and bioanalytical chemistry · 2025Article
- Can the clinical sign "head-turning sign" and simple questions in "Neucop-Q" predict amyloid β pathology?Alzheimer's research & therapy · 2024Article
- Plasma amyloid beta X-42/X-40 ratio and cognitive decline in suspected early and preclinical Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024Article
- The appropriate sample-handling procedure for measuring the plasma β-amyloid level using a fully automated immunoassay.Scientific reports · 2024Article
- Is blood pTau a reliable indicator of the CSF status? A narrative review.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024Review
- Towards early diagnosis of Alzheimer's disease: advances in immune-related blood biomarkers and computational approaches.Frontiers in immunology · 2024Review
- The emerging role of blood biomarkers in diagnosis and treatment of Alzheimer's disease.European geriatric medicine · 2023Article
- Review
- Morphometric and Nanomechanical Screening of Peripheral Blood Cells with Atomic Force Microscopy for Label-Free Assessment of Alzheimer's Disease, Parkinson's Disease, and Amyotrophic Lateral Sclerosis.International journal of molecular sciences · 2023Review
- Performance of plasma Aβ42/40, measured using a fully automated immunoassay, across a broad patient population in identifying amyloid status.Alzheimer's research & therapy · 2023Article
- Profiling of plasma biomarkers in the context of memory assessment in a tertiary memory clinic.Translational psychiatry · 2023Article
- Assessment of Plasma and Cerebrospinal Fluid Biomarkers in Different Stages of Alzheimer's Disease and Frontotemporal Dementia.International journal of molecular sciences · 2023Article
- Evaluation of Blood-Based Plasma Biomarkers as Potential Markers of Amyloid Burden in Preclinical Alzheimer's Disease.Journal of Alzheimer's disease : JAD · 2023Article
Corrections and comments
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Authors and funding
20 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundClinicians, researchers, and patients alike would greatly benefit from more accessible and inexpensive biomarkers for neural β-amyloid (Aβ). We aimed to assess the performance of fully automated plasma Aβ immunoassays, which correlate significantly with immunoprecipitation mass spectrometry assays, in predicting brain Aβ status as determined by visual read assessment of amyloid positron emission tomography (PET).
methodsThe plasma Aβ42/Aβ40 ratio was measured using a fully automated immunoassay platform (HISCL series) in two clinical studies (discovery and validation studies). The discovery and validation sample sets were retrospectively and randomly selected from participants with early Alzheimer's disease (AD) identified during screening for the elenbecestat Phase 3 program.
resultsWe included 197 participants in the discovery study (mean [SD] age 71.1 [8.5] years; 112 females) and 200 in the validation study (age 70.8 [7.9] years; 99 females). The plasma Aβ42/Aβ40 ratio predicted amyloid PET visual read status with areas under the receiver operating characteristic curves of 0.941 (95% confidence interval [CI] 0.910-0.973) and 0.868 (95% CI 0.816-0.920) in the discovery and validation studies, respectively. In the discovery study, a cutoff value of 0.102 was determined based on maximizing the Youden Index, and the sensitivity and specificity were calculated to be 96.0% (95% CI 90.1-98.9%) and 83.5% (95% CI 74.6-90.3%), respectively. Using the same cutoff value, the sensitivity and specificity in the validation study were calculated to be 88.0% (95% CI 80.0-93.6%) and 72.0% (95% CI 62.1-80.5%), respectively.
conclusionsThe plasma Aβ42/Aβ40 ratio measured using the HISCL series achieved high accuracy in predicting amyloid PET status. Since our blood-based immunoassay system is less invasive and more accessible than amyloid PET and cerebrospinal fluid testing, it may contribute to the diagnosis of AD in routine clinical practice.
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