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P4‐242: A case‐control cohort study to define a threshold for the tau/abeta42 ratio in cerebrospinal fluid optimized for diagnosis of Alzheimer's disease
Author(s) -
Egan Michael,
Mo Yi,
Stromswold Julie,
Wilson Kimberly,
Holder Daniel,
Sur Cyrille,
Laterza Omar,
Savage Mary J.,
Struyk Arie,
Weiss Christy,
Cowes Arturo,
Bush Michele M.,
DeSilva Ganga,
Teunissen Charlotte E.,
White Linda,
Burke James,
Sando Sigrid,
Macaulay S. Lance,
Brathen Geir,
Luthman Johan,
Scheltens Philip,
Michelson David
Publication year - 2015
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2015.08.071
Subject(s) - concordance , cutoff , cerebrospinal fluid , medicine , dementia , pathology , cohort , nuclear medicine , population , gastroenterology , disease , physics , environmental health , quantum mechanics
Amyloid ß(42) assays have been evaluated for key performance characteristics. Methods: A series of CSF samples were prepared to determine key assay performance characteristics. Both exogenous spiked and endogenous CSF samples were evaluated alongside buffer controls. General verification and validation principals were followed to determine linearity, precision, analytical sensitivity, carryover, hook-effect, and interference. Results: The xMAP Tau Assay is linear from 36 pg/mL to 2068 pg/mL. The reportable limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) for Tau are 24 pg/mL, 35 pg/mL, and 43 pg/ mL respectively. Total within laboratory imprecision ranged from 5% to 15% for Tau. The xMAP Amyloid ß(42) Assay is linear from 78 pg/mL to 12541 pg/mL. The reportable LoB, LoD, and LoQ for Ab(42) are 22 pg/mL, 33 pg/mL, and 45 pg/mL respectively. Total within laboratory imprecision ranged from 5% to 8% for Amyloid ß(42). No hook-effect or carryover was seen in either assay. For the interferents tested, no interfering substances were identified for either assay. Conclusions: The Luminex xMAP Tau/ Amyloid ß(42) assays performance characteristics support a potential companion diagnostic. The xMAP Tau/Amyloid ß(42) assays in development are demonstrating capability of identifying patients with prodromal AD who may benefit from treatment with a BACE inhibitor, thereby facilitating early intervention and potentially improving outcomes. The xMAP Tau/Amyloid ß(42) assays are currently in development and have not been approved by the FDA or other regulatory agencies.