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

Authors
  • Shaw, Leslie M1
  • Waligorska, Teresa1
  • Fields, Leona1
  • Korecka, Magdalena1
  • Figurski, Michal1
  • Trojanowski, John Q1
  • Eichenlaub, Udo2
  • Wahl, Simone2
  • Quan, Marian3
  • Pontecorvo, Michael J4
  • Lachno, D Richard5
  • Talbot, Jayne A6
  • Andersen, Scott W6
  • Siemers, Eric R6
  • Dean, Robert A7
  • 1 Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
  • 2 Roche Diagnostics GmbH, Bavaria, Germany. , (Germany)
  • 3 Roche Diagnostics, Indianapolis, IN, USA. , (India)
  • 4 Clinical Development, Avid Radiopharmaceuticals, Philadelphia, PA, USA.
  • 5 Eli Lilly and Company, Windlesham, Surrey, UK.
  • 6 Eli Lilly and Company, Indianapolis, IN, USA. , (India)
  • 7 Indiana University School of Medicine, Indianapolis, IN, USA. , (India)
Type
Published Article
Journal
Alzheimer's & dementia (Amsterdam, Netherlands)
Publication Date
Jan 01, 2018
Volume
10
Pages
698–705
Identifiers
DOI: 10.1016/j.dadm.2018.07.002
PMID: 30426066
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

An Elecsys® Amyloid β (Aβ [1-42]) immunoassay cutoff for classification of patients with Alzheimer's disease was investigated. 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). 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). 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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