1. Derivation of cutoffs for the Elecsys® amyloid β (1–42) assay in Alzheimer's disease
- Author
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Leslie M. Shaw, Teresa Waligorska, Leona Fields, Magdalena Korecka, Michal Figurski, John Q. Trojanowski, Udo Eichenlaub, Simone Wahl, Marian Quan, Michael J. Pontecorvo, D. Richard Lachno, Jayne A. Talbot, Scott W. Andersen, Eric R. Siemers, and Robert A. Dean
- Subjects
Alzheimer's disease ,Biomarkers ,Immunoassay ,Amyloid β ,Cerebrospinal fluid ,Method comparison ,Neurology. Diseases of the nervous system ,RC346-429 ,Geriatrics ,RC952-954.6 - 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.
- Published
- 2018
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