Abstract
INTRODUCTION
We aimed to evaluate clinical interpretation cutpoints for two plasma phosphorylated tau (p-tau)217 assays (ALZpath and Lumipulse) as predictors of amyloid status for implementation in clinical practice.
METHODS
Clinical performance of plasma p-tau217 against amyloid positron emission tomography status was evaluated in participants with mild cognitive impairment or mild dementia (n = 427).
RESULTS
Using a one-cutpoint approach (negative/positive), neither assay achieved ≥ 90% in both sensitivity and specificity. A two-cutpoint approach yielding 92% sensitivity and 96% specificity provided the desired balance of false positives and false negatives, while categorizing 20% and 39% of results as indeterminate for the Lumipulse and ALZpath assays, respectively.
DISCUSSION
This study provides a systematic framework for selection of assay-specific cutpoints for clinical use of plasma p-tau217 for determination of amyloid status. Our findings suggest that a two-cutpoint approach may have advantages in optimizing diagnostic accuracy while minimizing potential harm from false positive results.
Highlights
Phosphorylated tau (p-tau)217 cutpoints for detection of amyloid pathology were established.
A two-cutpoint approach exhibited the best performance for clinical laboratory use.
p-tau217 assays differed in the percentage of results categorized as intermediate.
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This post is Copyright: Daniel J. Figdore,
Michael Griswold,
Joshua A. Bornhorst,
Jonathan Graff‐Radford,
Vijay K. Ramanan,
Prashanthi Vemuri,
Val J. Lowe,
David S. Knopman,
Clifford R. Jack Jr.,
Ronald C. Petersen,
Alicia Algeciras‐Schimnich | July 19, 2024