Cargando…

A Novel Automated Chemiluminescence Method for Detecting Cerebrospinal Fluid Amyloid-Beta 1-42 and 1-40, Total Tau and Phosphorylated-Tau: Implications for Improving Diagnostic Performance in Alzheimer’s Disease

Recently, a fully automated instrument for the detection of the Cerebrospinal Fluid (CSF) biomarker for Alzheimer’s disease (AD) (low concentration of Amyloid-beta 42 (Aβ42), high concentration of total tau (T-tau) and Phosphorylated-tau (P-tau181)), has been implemented, namely CLEIA. We conducted...

Descripción completa

Detalles Bibliográficos
Autores principales: Arcaro, Marina, Fenoglio, Chiara, Serpente, Maria, Arighi, Andrea, Fumagalli, Giorgio G., Sacchi, Luca, Floro, Stefano, D’Anca, Marianna, Sorrentino, Federica, Visconte, Caterina, Perego, Alberto, Scarpini, Elio, Galimberti, Daniela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9599653/
https://www.ncbi.nlm.nih.gov/pubmed/36289929
http://dx.doi.org/10.3390/biomedicines10102667
_version_ 1784816646852968448
author Arcaro, Marina
Fenoglio, Chiara
Serpente, Maria
Arighi, Andrea
Fumagalli, Giorgio G.
Sacchi, Luca
Floro, Stefano
D’Anca, Marianna
Sorrentino, Federica
Visconte, Caterina
Perego, Alberto
Scarpini, Elio
Galimberti, Daniela
author_facet Arcaro, Marina
Fenoglio, Chiara
Serpente, Maria
Arighi, Andrea
Fumagalli, Giorgio G.
Sacchi, Luca
Floro, Stefano
D’Anca, Marianna
Sorrentino, Federica
Visconte, Caterina
Perego, Alberto
Scarpini, Elio
Galimberti, Daniela
author_sort Arcaro, Marina
collection PubMed
description Recently, a fully automated instrument for the detection of the Cerebrospinal Fluid (CSF) biomarker for Alzheimer’s disease (AD) (low concentration of Amyloid-beta 42 (Aβ42), high concentration of total tau (T-tau) and Phosphorylated-tau (P-tau181)), has been implemented, namely CLEIA. We conducted a comparative analysis between ELISA and CLEIA methods in order to evaluate the analytical precision and the diagnostic performance of the novel CLEIA system on 111 CSF samples. Results confirmed a robust correlation between ELISA and CLEIA methods, with an improvement of the accuracy with the new CLEIA methodology in the detection of the single biomarkers and in their ratio values. For Aβ42 regression analysis with Passing–Bablok showed a Pearson correlation coefficient r = 0.867 (0.8120; 0.907% 95% CI p < 0.0001), T-tau analysis: r = 0.968 (0.954; 0.978% 95% CI p < 0.0001) and P-tau181: r = 0.946 (0.922; 0.962 5% 95% CI p < 0.0001). The overall ROC AUC comparison between ROC in ELISA and ROC in CLEIA confirmed a more accurate ROC AUC with the new automatic method: T-tau AUC ELISA = 0.94 (95% CI 0.89; 0.99 p < 0.0001) vs. AUC CLEIA = 0.95 (95% CI 0.89; 1.00 p < 0.0001), and P-tau181 AUC ELISA = 0.91 (95% CI 0.85; 0.98 p < 0.0001) vs. AUC CLEIA = 0.98 (95% CI 0.95; 1.00 p < 0.0001). The performance of the new CLEIA method in automation is comparable and, for tau and P-tau181, even better, as compared with standard ELISA. Hopefully, in the future, automation could be useful in clinical diagnosis and also in the context of clinical studies.
format Online
Article
Text
id pubmed-9599653
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-95996532022-10-27 A Novel Automated Chemiluminescence Method for Detecting Cerebrospinal Fluid Amyloid-Beta 1-42 and 1-40, Total Tau and Phosphorylated-Tau: Implications for Improving Diagnostic Performance in Alzheimer’s Disease Arcaro, Marina Fenoglio, Chiara Serpente, Maria Arighi, Andrea Fumagalli, Giorgio G. Sacchi, Luca Floro, Stefano D’Anca, Marianna Sorrentino, Federica Visconte, Caterina Perego, Alberto Scarpini, Elio Galimberti, Daniela Biomedicines Article Recently, a fully automated instrument for the detection of the Cerebrospinal Fluid (CSF) biomarker for Alzheimer’s disease (AD) (low concentration of Amyloid-beta 42 (Aβ42), high concentration of total tau (T-tau) and Phosphorylated-tau (P-tau181)), has been implemented, namely CLEIA. We conducted a comparative analysis between ELISA and CLEIA methods in order to evaluate the analytical precision and the diagnostic performance of the novel CLEIA system on 111 CSF samples. Results confirmed a robust correlation between ELISA and CLEIA methods, with an improvement of the accuracy with the new CLEIA methodology in the detection of the single biomarkers and in their ratio values. For Aβ42 regression analysis with Passing–Bablok showed a Pearson correlation coefficient r = 0.867 (0.8120; 0.907% 95% CI p < 0.0001), T-tau analysis: r = 0.968 (0.954; 0.978% 95% CI p < 0.0001) and P-tau181: r = 0.946 (0.922; 0.962 5% 95% CI p < 0.0001). The overall ROC AUC comparison between ROC in ELISA and ROC in CLEIA confirmed a more accurate ROC AUC with the new automatic method: T-tau AUC ELISA = 0.94 (95% CI 0.89; 0.99 p < 0.0001) vs. AUC CLEIA = 0.95 (95% CI 0.89; 1.00 p < 0.0001), and P-tau181 AUC ELISA = 0.91 (95% CI 0.85; 0.98 p < 0.0001) vs. AUC CLEIA = 0.98 (95% CI 0.95; 1.00 p < 0.0001). The performance of the new CLEIA method in automation is comparable and, for tau and P-tau181, even better, as compared with standard ELISA. Hopefully, in the future, automation could be useful in clinical diagnosis and also in the context of clinical studies. MDPI 2022-10-21 /pmc/articles/PMC9599653/ /pubmed/36289929 http://dx.doi.org/10.3390/biomedicines10102667 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Arcaro, Marina
Fenoglio, Chiara
Serpente, Maria
Arighi, Andrea
Fumagalli, Giorgio G.
Sacchi, Luca
Floro, Stefano
D’Anca, Marianna
Sorrentino, Federica
Visconte, Caterina
Perego, Alberto
Scarpini, Elio
Galimberti, Daniela
A Novel Automated Chemiluminescence Method for Detecting Cerebrospinal Fluid Amyloid-Beta 1-42 and 1-40, Total Tau and Phosphorylated-Tau: Implications for Improving Diagnostic Performance in Alzheimer’s Disease
title A Novel Automated Chemiluminescence Method for Detecting Cerebrospinal Fluid Amyloid-Beta 1-42 and 1-40, Total Tau and Phosphorylated-Tau: Implications for Improving Diagnostic Performance in Alzheimer’s Disease
title_full A Novel Automated Chemiluminescence Method for Detecting Cerebrospinal Fluid Amyloid-Beta 1-42 and 1-40, Total Tau and Phosphorylated-Tau: Implications for Improving Diagnostic Performance in Alzheimer’s Disease
title_fullStr A Novel Automated Chemiluminescence Method for Detecting Cerebrospinal Fluid Amyloid-Beta 1-42 and 1-40, Total Tau and Phosphorylated-Tau: Implications for Improving Diagnostic Performance in Alzheimer’s Disease
title_full_unstemmed A Novel Automated Chemiluminescence Method for Detecting Cerebrospinal Fluid Amyloid-Beta 1-42 and 1-40, Total Tau and Phosphorylated-Tau: Implications for Improving Diagnostic Performance in Alzheimer’s Disease
title_short A Novel Automated Chemiluminescence Method for Detecting Cerebrospinal Fluid Amyloid-Beta 1-42 and 1-40, Total Tau and Phosphorylated-Tau: Implications for Improving Diagnostic Performance in Alzheimer’s Disease
title_sort novel automated chemiluminescence method for detecting cerebrospinal fluid amyloid-beta 1-42 and 1-40, total tau and phosphorylated-tau: implications for improving diagnostic performance in alzheimer’s disease
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9599653/
https://www.ncbi.nlm.nih.gov/pubmed/36289929
http://dx.doi.org/10.3390/biomedicines10102667
work_keys_str_mv AT arcaromarina anovelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT fenogliochiara anovelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT serpentemaria anovelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT arighiandrea anovelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT fumagalligiorgiog anovelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT sacchiluca anovelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT florostefano anovelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT dancamarianna anovelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT sorrentinofederica anovelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT viscontecaterina anovelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT peregoalberto anovelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT scarpinielio anovelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT galimbertidaniela anovelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT arcaromarina novelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT fenogliochiara novelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT serpentemaria novelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT arighiandrea novelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT fumagalligiorgiog novelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT sacchiluca novelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT florostefano novelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT dancamarianna novelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT sorrentinofederica novelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT viscontecaterina novelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT peregoalberto novelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT scarpinielio novelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease
AT galimbertidaniela novelautomatedchemiluminescencemethodfordetectingcerebrospinalfluidamyloidbeta142and140totaltauandphosphorylatedtauimplicationsforimprovingdiagnosticperformanceinalzheimersdisease