Current research indicates that plasma p-tau, including p-tau 217, is concordant with amyloid status defined by either CSF biomarker testing or PET scan analysis, and is able to differentiate between AD and non-AD neurodegenerative diseases and to predict progression to AD. Blood-based biomarkers, such as plasma p-tau, could potentially be used as inclusion criteria or to evaluate target engagement and treatment efficacy, and could further advance the development of disease-modifying treatments in the field of AD and related disorders. This assay is designed specifically for the quantitative measurement of tau phosphorylated at threonine 217 (p-tau 217) in human plasma.