P1‐203: Verification of the Analytical Performance of the Fully Automated Lumipulse g β‐Amyloid 1‐42 and Lumipulse g Total TAU Assays

Abstract

preclinical diagnosis for ethical reasons, and to the possibility of using "conversion to dementia" as a gold standard for diagnosis (in the lack of pathology data). The resulting 5 sequential phases were: 1) pilot studies, 2) clinical assay development for clinical disease, 3) prospective longitudinal repository studies, 4) prospective diagnostic studies, and 5) disease control studies (Table). Because of the required adaptations, biomarkers for AD can be used for biomarker-based diagnoses and not yet for screening purposes. Conclusions: The adaptation of the oncology framework to AD aims to systematize the validation of AD biomarkers. The important limitations restrict the generalizability of results to the general population and the use of such biomarkers for screening purposes. This initiative should be considered as a first, although necessary, step to the definition of a systematic validation of biomarkers for AD.