Evaluation of the EUROIMMUN automated chemiluminescence immunoassays for measurement of four core biomarkers for Alzheimer’s disease in cerebrospinal fluid

oleh: Katharina Römpler, Philipp Arendt, Britta Brix, Viola Borchardt-Lohölter, Anette Schulz, Mandy Busse, Stefan Busse

Format: Article
Diterbitkan: Elsevier 2024-08-01

Deskripsi

Introduction: Robust immunoassays for quantification of Alzheimer's disease (AD)-specific biomarkers are required for routine diagnostics. We report analytical performance characteristics of four new chemiluminescence immunoassays (ChLIA, EUROIMMUN) running on closed, fully automated random-access instruments for quantification of Aβ1-40, Aβ1-42, tTau, and pTau(181) in human cerebrospinal fluid (CSF). Methods: ChLIAs were validated according to the guidelines of the Clinical and Laboratory Standards Institute (CLSI). Optimal cut-offs for biomarkers and biomarker ratios were determined using samples from 219 AD patients and 220 patients with AD-related symptoms. For performance comparison, biomarker concentrations were measured in 110 diagnostic leftover samples using the ChLIAs and established Lumipulse G assays (Fujirebio). Results: All ChLIAs met CLSI criteria. Overall agreement between assays was 89.0%–97.3 % with highly correlating results (Pearson's correlation coefficients: 0.82–0.99). Passing-Bablok regression analysis revealed systematic differences. Discussion: EUROIMMUN ChLIAs showed good analytical performances and represent new valuable tools for diagnostics of AD.