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Performance Evaluation of an Automated ELISA System for Alzheimer's Disease Detection in Clinical Routine.
J Alzheimers Dis 2016; 54(1):55-67JA

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 new CSF immunoassays, EUROIMMUNtrademark 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 (INNOTESTtrademark). 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 the Aβ1-42/Aβ1-40 ratio in AD diagnosis need to be validated in large multi-center studies.

Authors+Show Affiliations

Laboratory of Clinical Neurochemistry, Department of Medicine, University of Perugia, Perugia, Italy.Laboratory of Clinical Neurochemistry, Department of Medicine, University of Perugia, Perugia, Italy.Clinica Neurologica, Dipartimento di Medicina, Università di Perugia, Perugia, Italy.Laboratory of Clinical Neurochemistry, Department of Medicine, University of Perugia, Perugia, Italy.Laboratory of Clinical Neurochemistry, Department of Medicine, University of Perugia, Perugia, Italy.Laboratory of Clinical Neurochemistry, Department of Medicine, University of Perugia, Perugia, Italy.Clinica Neurologica, Dipartimento di Medicina, Università di Perugia, Perugia, Italy.Laboratory of Clinical Neurochemistry, Department of Medicine, University of Perugia, Perugia, Italy.Laboratory of Clinical Neurochemistry, Department of Medicine, University of Perugia, Perugia, Italy.ADx NeuroSciences, Gent, Belgium.ADx NeuroSciences, Gent, Belgium.Clinica Neurologica, Dipartimento di Medicina, Università di Perugia, Perugia, Italy. IRRCS Fondazione S.Lucia, Rome, Italy.Laboratory of Clinical Neurochemistry, Department of Medicine, University of Perugia, Perugia, Italy. Clinica Neurologica, Dipartimento di Medicina, Università di Perugia, Perugia, Italy.

Pub Type(s)

Evaluation Studies
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27447425

Citation

Chiasserini, Davide, et al. "Performance Evaluation of an Automated ELISA System for Alzheimer's Disease Detection in Clinical Routine." Journal of Alzheimer's Disease : JAD, vol. 54, no. 1, 2016, pp. 55-67.
Chiasserini D, Biscetti L, Farotti L, et al. Performance Evaluation of an Automated ELISA System for Alzheimer's Disease Detection in Clinical Routine. J Alzheimers Dis. 2016;54(1):55-67.
Chiasserini, D., Biscetti, L., Farotti, L., Eusebi, P., Salvadori, N., Lisetti, V., ... Parnetti, L. (2016). Performance Evaluation of an Automated ELISA System for Alzheimer's Disease Detection in Clinical Routine. Journal of Alzheimer's Disease : JAD, 54(1), pp. 55-67. doi:10.3233/JAD-160298.
Chiasserini D, et al. Performance Evaluation of an Automated ELISA System for Alzheimer's Disease Detection in Clinical Routine. J Alzheimers Dis. 2016 07 22;54(1):55-67. PubMed PMID: 27447425.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Performance Evaluation of an Automated ELISA System for Alzheimer's Disease Detection in Clinical Routine. AU - Chiasserini,Davide, AU - Biscetti,Leonardo, AU - Farotti,Lucia, AU - Eusebi,Paolo, AU - Salvadori,Nicola, AU - Lisetti,Viviana, AU - Baschieri,Francesca, AU - Chipi,Elena, AU - Frattini,Giulia, AU - Stoops,Erik, AU - Vanderstichele,Hugo, AU - Calabresi,Paolo, AU - Parnetti,Lucilla, PY - 2016/7/23/entrez PY - 2016/7/23/pubmed PY - 2018/1/30/medline KW - Alzheimer’s disease KW - amyloid KW - biomarker KW - cerebrospinal fluid KW - mild cognitive impairment KW - tau SP - 55 EP - 67 JF - Journal of Alzheimer's disease : JAD JO - J. Alzheimers Dis. VL - 54 IS - 1 N2 - 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 new CSF immunoassays, EUROIMMUNtrademark 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 (INNOTESTtrademark). 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 the Aβ1-42/Aβ1-40 ratio in AD diagnosis need to be validated in large multi-center studies. SN - 1875-8908 UR - https://www.unboundmedicine.com/medline/citation/27447425/Performance_Evaluation_of_an_Automated_ELISA_System_for_Alzheimer's_Disease_Detection_in_Clinical_Routine_ L2 - https://content.iospress.com/openurl?genre=article&amp;id=doi:10.3233/JAD-160298 DB - PRIME DP - Unbound Medicine ER -