P1‐276: analytical performance of a fully automated chemiluminescent β‐amyloid 1‐40 assay on the lumipulse g series

The major constituents of amyloid plaques in the brain of Alzheimer's disease (AD) patients are β-amyloid peptides consisting of 42 and 40 amino acids (Aβ1-42 and Aβ1-40). Quantification of the two amyloid peptides in cerebrospinal fluid (CSF) has proven to be of value in the diagnosis of AD and distinguishing AD from other neurodegenerative dementias. Analytical performance of the novel fully automated Lumipulse G β-Amyloid 1-40 assay (under development) for the quantification of β-amyloid1-40 was evaluated. The LUMIPULSE G instrument series use single, ready-to-use immunoreaction cartridges with a throughput of 60 and 120 tests/hour for the G600II and the G1200 instrument, respectively. Each cartridge generates quantitative results within approximately 30 minutes. The Lumipulse G β-Amyloid 1-40 assay under development uses established monoclonal antibodies. Analytical assay performance was characterized according to CLSI guidelines. Using a panel of CSF and control samples, assay variability was determined and resulted in total CV ≤ 7% and ≤ 4%, respectively. The LoD was shown to be < 5 pg/mL and the LoQ < 15 pg/mL. No high dose hook effect was observed for samples containing up to 125000 pg/mL of β-amyloid1-40. Linearity was shown across the clinical relevant range. A method comparison study with the INNOTEST® β-AMYLOID (1-40) assay demonstrated a good correlation (r>0.90). Automation, the mono test cartridge principle, short throughput times, and instrument flexibility are key attributes of the LUMIPULSE G instrument series making it the ideal platform to fulfill today's needs for rapid and accurate quantification of CSF biomarkers. The novel Lumipulse G β-Amyloid 1-40 assay (under development) shows good sensitivity and precision, correlates well with the INNOTEST assay and allows for the calculation of the β-amyloid1-42/ β-amyloid1-40 ratio.