Analytical performance overview of the Lumipulse G pTau 181 Plasma RUO

Studies have shown that changes in Alzheimer’s disease (AD) biomarker levels occur in blood at approximately the same time as in cerebrospinal fluid (CSF). Therefore, plasma‐based testing could be used as a simple, accessible, and scalable approach to help support the diagnosis of AD, avoiding the complexity of CSF sampling, and the high costs and limited availability of PET imaging. It was demonstrated that plasma pTau181 has the potential to be a good predictor of amyloid PET positivity, has proven to differentiate between AD and non‐AD neurodegenerative diseases, and is able to predict progression to AD. The aim of this study was to determine the preliminary analytical performance of the newly developed Lumipulse G pTau 181 Plasma RUO assay.