Benchmarking of a multi-biomarker low-volume panel for Alzheimer's disease and related dementia research

Alzheimers Dement. 2024 Nov 22. doi: 10.1002/alz.14413. Online ahead of print.

Abstract

Introduction: In the research setting, obtaining accurate established biomarker measurements and maximizing use of the precious samples is key. Accurate technologies are available for Alzheimer's disease (AD), but no platform can measure all the established and emerging biomarkers in one run. The NUcleic acid Linked Immuno-Sandwich Assay (NULISA) is a technology that requires 15 µL of sample to measure more than 100 analytes.

Methods: We compared AD-relevant biomarkers included in the NULISA against validated assays in cerebrospinal fluid (CSF) and plasma.

Results: CSF measures of amyloid beta 42/40, and phosphorylated tau (p-tau)217 are highly correlated when measured by immunoassay, mass spectrometry, or NULISA. In plasma, p-tau217 performance is similar to that reported with other technologies when predicting amyloidosis. Other biomarkers show a wide range of correlation values depending on the fluid and the platform.

Discussion: The NULISA multiplexed platform produces reliable results for established biomarkers in CSF that are useful in research settings, with the advantage of measuring additional biomarkers using minimal sample volume.

Highlights: We tested the novel technology NUcleic acid Linked Immuno-Sandwich Assay (NULISA) in the dementia research setting. NULISA multiplexed platform produces reliable results for established and emerging biomarkers using minimal sample volume. Cerebrospinal fluid measures of amyloid beta 42/40, and phosphorylated tau (p-tau)217 are highly correlated when measured by immunoassay, mass spectrometry, or NULISA. In plasma, p-tau217 performance is similar to that reported with other technologies when predicting amyloidosis. NULISA measures are useful in research settings, with the advantage of measuring additional biomarkers using minimal sample volume.

Keywords: NUcleic acid Linked Immuno‐Sandwich Assay; amyloidosis biomarkers; biomarkers; multiplex.