Performance evaluation of an automated ELISA system for Alzheimer's disease detection in clinical routine

Davide Chiasserini, Leonardo Biscetti, Lucia Farotti, Paolo Eusebi, Nicola Salvadori, Viviana Lisetti, Francesca Baschieri, Elena Chipi, Giulia Frattini, Erik Stoops, Hugo Vanderstichele, Paolo Calabresi, Lucilla Parnetti

Research output: Contribution to journalArticle

Abstract

The variability of Alzheimer's disease (AD) cerebrospinal fluid (CSF) biomarkers undermines their full-fledged introduction into routine diagnostics and clinical trials. Automation may help to increase precision and decrease operator errors, eventually improving the diagnostic performance. Here we evaluated three newCSF immunoassays,EUROIMMUN™ amyloid-β 1-40 (Aβ1-40), amyloid-β 1-42 (Aβ1-42), and total tau (t-tau), in combination with automated analysis of the samples. The CSF biomarkers were measured in a cohort consisting of AD patients (n = 28), mild cognitive impairment (MCI, n = 77), and neurological controls (OND, n = 35). MCI patients were evaluated yearly and cognitive functions were assessed by Mini-Mental State Examination. The patients clinically diagnosed with AD and MCI were classified according to the CSF biomarkers profile following NIA-AA criteria and the Erlangen score. Technical evaluation of the immunoassays was performed together with the calculation of their diagnostic performance. Furthermore, the results for EUROIMMUN Aβ1-42 and t-tau were compared to standard immunoassay methods (INNOTEST™). EUROIMMUN assays for Aβ1-42 and t-tau correlated with INNOTEST (r = 0.83, p < 0.001 for both) and allowed a similar interpretation of the CSF profiles. The Aβ1-42/Aβ1-40 ratio measured with EUROIMMUN was the best parameter for AD detection and improved the diagnostic accuracy of Aβ1-42 (area under the curve = 0.93). In MCI patients, the Aβ1-42/Aβ1-40 ratio was associated with cognitive decline and clinical progression to AD. The diagnostic performance of the EUROIMMUN assays with automation is comparable to other currently used methods. The variability of the method and the value of theAβ1-42/Aβ1-40 ratio inADdiagnosis need to be validated in large multi-center studies.

Original languageEnglish
Pages (from-to)55-67
Number of pages13
JournalJournal of Alzheimer's Disease
Volume54
Issue number1
DOIs
Publication statusPublished - Aug 23 2016

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Keywords

  • Alzheimer's disease
  • Amyloid
  • Biomarker
  • Cerebrospinal fluid
  • Mild cognitive impairment
  • Tau

ASJC Scopus subject areas

  • Clinical Psychology
  • Geriatrics and Gerontology
  • Psychiatry and Mental health

Cite this

Chiasserini, D., Biscetti, L., Farotti, L., Eusebi, P., Salvadori, N., Lisetti, V., Baschieri, F., Chipi, E., Frattini, G., Stoops, E., Vanderstichele, H., Calabresi, P., & Parnetti, L. (2016). Performance evaluation of an automated ELISA system for Alzheimer's disease detection in clinical routine. Journal of Alzheimer's Disease, 54(1), 55-67. https://doi.org/10.3233/JAD-160298