Find in Library
Search millions of books, articles, and more
Indexed Open Access Databases
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.