Derivation of cutoffs for the Elecsys® amyloid β (1–42) assay in Alzheimer's disease

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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.

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Shaw, L. M., Waligorska, T., Fields, L., Korecka, M., Figurski, M., Trojanowski, J. Q., … Dean, R. A. (2018). Derivation of cutoffs for the Elecsys® amyloid β (1–42) assay in Alzheimer’s disease. Alzheimer’s and Dementia: Diagnosis, Assessment and Disease Monitoring, 10, 698–705. https://doi.org/10.1016/j.dadm.2018.07.002

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