Hostname: page-component-cb9f654ff-mx8w7 Total loading time: 0 Render date: 2025-08-31T06:02:05.200Z Has data issue: false hasContentIssue false

P.002 Comprehensive validation of two commercial immunoassays for the biological diagnosis of Alzheimer’s Disease a laboratory diagnostic test

Published online by Cambridge University Press:  10 July 2025

A Mammel
Affiliation:
(Bellingham)
G Hsiung
Affiliation:
(Vancouver)
P Kumar
Affiliation:
(Vancouver)*
A Mousavi
Affiliation:
(Vancouver)
I Mackenzie
Affiliation:
(Vancouver)
V Hirsch-Reinshagen
Affiliation:
(Vancouver)
M Encarnacion
Affiliation:
(Vancouver)
K Hallett
Affiliation:
(Bellingham)
P Gil
Affiliation:
(Bellingham)
H Frykman
Affiliation:
(Vancouver)
Rights & Permissions [Opens in a new window]

Abstract

Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.

Background: Plasma pTau217 is a robust biomarker for the diagnosis of Alzheimer’s disease (AD). However, most pTau217 assays are not widely available for clinical testing. We assessed the performance of two commercially available plasma pTau217 immunoassays in a clinical diagnostic laboratory for AD diagnosis. Methods: 219 plasma samples from healthy controls with negative amyloid PET, 115 plasma samples from pathology-confirmed and 263 samples with confirmed amyloid PET were selected. Plasma pTau217 levels were measured using the ALZpath pTau217 assay on the Quanterix HD-X Simoa platform and the Lumipulse pTau217 assay on the Lumipulse G1200 platform at and BC Neuroimmunology Lab and Neurocode USA. Results: For the ALZpath assay, the coefficients were 10.4%, 10.4%, and 9.9%, and for the Fujirebio assay, were 12.1%, 12.2%, and 5.3%, respectively. Sample stability and interference were similar between the two assays, although moderate heterophilic antibody interference and reduced frozen sample stability at -20˚C were observed for the Fujirebio assay. Both assays demonstrated similar clinical performance and differentiated individuals with AD (ALZpath AUC = 0.94; Fujirebio AUC = 0.90). Conclusions: The performance of the two pTau 217 assays was comparable. The clinical separation between the healthy controls and those with Amyloid pathology was nearly complete for both assays.

Information

Type
Abstracts
Copyright
© The Author(s), 2025. Published by Cambridge University Press on behalf of Canadian Neurological Sciences Federation