Research test kit Lumipulse®

for neurodegenerative diseasesfor phosphorylated tau proteinclinical

Immunoassay to be used with the automated LUMIPULSE G System for the quantitative measurement of Tau phosphorylated at threonine 181 (pTau 181) in human plasma. This product is not for use in diagnostic procedures. Details Background Alzheimer's disease, the most common form of dimentia, is a neurodegenerative disorder histologically characterized by the accumulation of intracellular neurofibrillary tangles and extracellular amyloid plaques throughout the cortical and limbic brain regions. The ultrastructure of neurofibrillary tangles is made up of paired helical filaments composed mainly of abnormally hyperphosphorylated Tau protein (pTau). The major components of the amyloid deposits are the 40- and 42-amino acid-long β-amyloid peptides, which are derived from integral membrane-bound amyloid precursor protein. In Alzheimer's disease pathology, the phosphorylation of Tau protein is disturbed, leading to hyperphosphorylation and the emergence of new sites of phosphorylation. The combination of decreased concentrations of β-amyloid1-42 and increased concentrations of total Tau and pTau is considered to be a pathological biomarker signature in cerebrospinal fluid (CSF) that is diagnostic for Alzheimer's disease.2,3 Today, CSF biomarker analysis has become part of routine clinical testing, however, measuring biomarkers in blood could improve future test strategies. Current research indicates that plasma pTau, including pTau 181, is concordant with amyloid PET, and is able to differentiate between Alzheimer's disease and non-Alzheimer's disease neurodegenerative diseases and to predict progression to Alzheimer's disease.Blood-based biomarkers, such as plasma pTau,