• June Kaplow, Manu Vandijck, Julia Gray, Michio Kanekiyo, Els Huyck, C J Traynham, Rianne Esquivel, Anne M Fagan, and Johan Luthman.
• Eisai Inc., Woodcliff Lake, NJ, USA.
• Alzheimers Dement. 2020 Jan 1; 16 (1): 144-152.

IntroductionCerebrospinal 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.MethodsCSF 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).ResultsVirtually 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.DiscussionLumipulse CSF biomarker measures with validated cut-points have clinical utility in identifying AD pathology.© 2020 the Alzheimer's Association.

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