AAIC 2024 -- Alzheimer’s Disease (AD) is a major neurodegenerative disorder characterized by amyloid deposits in brain tissue and represents a continuously increasing global burden in need of disease-modifying therapeutic options. Amyloid beta 1-42 (Aβ1-42) and 1-40 (Aβ1-40) peptides and the amyloid beta 1-42/1-40 ratio are hallmarks of AD and are commonly monitored in cerebrospinal fluid (CSF) along other AD biomarkers, to support diagnosis and management of AD patients. Over the past few years, blood-based AD biomarkers have emerged as highly relevant and more practical alternatives to CSF biomarkers, and further technical performance characterization of the associated assays would be beneficial to the AD research and medical community. The LUMIPULSE® G β-Amyloid 1-42 and 1-40 Plasma assays are two-step chemiluminescent enzyme immunoassays (CLEIA) performed on the LUMIPULSE G1200 system and designed for the quantitative measurement of Aβ1-42 and Aβ1-40 in plasma specimens. We validated these two assays in EDTA plasma specimens in a CAP/CLIA environment, utilizing CLSI guidelines in setting validation parameters and acceptance criteria.

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