학술논문

Derivation of cutoffs for the Elecsys® amyloid β (1–42) assay in Alzheimer's disease
Document Type
article
Source
Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring, Vol 10, Iss 1, Pp 698-705 (2018)
Subject
Alzheimer's disease
Biomarkers
Immunoassay
Amyloid β
Cerebrospinal fluid
Method comparison
Neurology. Diseases of the nervous system
RC346-429
Geriatrics
RC952-954.6
Language
English
ISSN
2352-8729
Abstract
Abstract Introduction An Elecsys® Amyloid β (Aβ [1–42]) immunoassay cutoff for classification of patients with Alzheimer's disease was investigated. Methods Cerebrospinal fluid samples collected from patients with mild‐to‐moderate Alzheimer's disease were analyzed by Elecsys® immunoassays: (1) Aβ (1–42), (2) total tau, and (3) phosphorylated tau. Cutoffs (Aβ [1–42] and ratios with tau) were estimated by method comparison between AlzBio3 (n = 206), mixture modeling (n = 216), and concordance with florbetapir F 18 imaging‐based classification (n = 75). Results A 1065‐pg/mL (95% confidence interval: 985–1153) Elecsys® Aβ (1–42) cutoff provided 94% overall percentage agreement with AlzBio3. Comparable cutoff estimates (95% confidence interval) were derived from mixture modeling (equally weighted: 1017 [949–1205] pg/mL; prevalence weighted: 1172 [1081–1344] pg/mL) and concordance with florbetapir F 18 imaging (visual read: 1198 [998–1591] pg/mL; automated: 1198 [1051–1638] pg/mL). Discussion Based on three approaches, a 1100‐pg/mL Elecsys® Aβ (1–42) cutoff is suitable for clinical trials with similar populations and preanalytical handling.