Concordance of Lumipulse cerebrospinal fluid t-tau/Aβ42 ratio with amyloid PET status

June Kaplow, Manu Vandijck, Julia Gray, Michio Kanekiyo, Els Huyck, C. J. Traynham, Rianne Esquivel, Anne M. Fagan, Johan Luthman

Research output: Contribution to journalArticle

Abstract

Introduction: Cerebrospinal fluid (CSF) biomarkers can identify individuals with Alzheimer's disease (AD) pathology (eg, amyloid plaques, neurofibrillary tangles), but defined analyte cut-points using high-throughput automated assays are necessary for general clinical use. Methods: CSF amyloid β42 peptide (Aβ42), t-tau, and t-tau/Aβ42 were quantified by the Lumipulse platform in two test cohorts (A/B: Eisai BAN2401-201/MISSION AD E2609-301/302, n = 138; C: Knight Alzheimer's Disease Research Center (ADRC), n = 198), and receiver operating characteristic (ROC) curve analyses defined cut-points corresponding best to amyloid determinations using positron emission tomography (PET) imaging. The best-performing cut-point was then validated as a predictor of amyloid status in an independent cohort (D: MISSION AD E2609-301/302, n = 240). Results: Virtually identical t-tau/Aβ42 cut-points (∼0.54) performed best in both test cohorts and with similar accuracy (areas under ROC curve [AUCs] [A/B: 0.95; C: 0.94]). The cut-point yielded an overall percent agreement with amyloid PET of 85.0% in validation cohort D. Discussion: Lumipulse CSF biomarker measures with validated cut-points have clinical utility in identifying AD pathology.

Original languageEnglish
Pages (from-to)144-152
Number of pages9
JournalAlzheimer's and Dementia
Volume16
Issue number1
DOIs
StatePublished - Jan 1 2020

Keywords

  • Alzheimer's disease
  • Lumipulse
  • amyloid PET
  • assay validation
  • biomarker
  • cerebrospinal fluid
  • cut-point
  • t-tau/Aβ42 ratio

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    Kaplow, J., Vandijck, M., Gray, J., Kanekiyo, M., Huyck, E., Traynham, C. J., Esquivel, R., Fagan, A. M., & Luthman, J. (2020). Concordance of Lumipulse cerebrospinal fluid t-tau/Aβ42 ratio with amyloid PET status. Alzheimer's and Dementia, 16(1), 144-152. https://doi.org/10.1002/alz.12000