Lumipulse® G β-Amyloid 1-40 Immunoreaction Cartridges

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of β-amyloid1-40in human cerebrospinal fluid (CSF) .The Lumipulse G β-Amyloid 1-40 assay is intended to be used in conjunction with Lumipulse G β-Amyloid 1-42 assay to determine the amyloid ratio (β-amyloid1-42/ β-amyloid1-40ratio) in the clinical setting of dementia diagnosis.This CSF amyloid ratio (β-amyloid1-42/ β-amyloid1-40ratio) is intended to be used as an aid for diagnosis in patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline.The CSF amyloid ratio supports the probability of AD pathology only as an adjunct to other diagnostic evaluations.