P4‐230: From innotest to the fully automated chemiluminescent b‐amyloid(1‐42) and total tau assays on the LUMIPULSE®G instrument series: Taking quantification of Alzheimer's disease CSF biomarkers to the next level

Pereson, Sandra; Vandersteen, Annelies; Dekeyser, Filip; Dumont, Tinne; Vuyst, Katrien De; Vandezande, Wim; Gorteman, Kathleen; Vandeponseele, Paul; Hecke, Pieter Van; Dauwe, Martine; Jannes, Geert

doi:10.1016/j.jalz.2015.08.059

Cited by 4 publications

(2 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although major advances have been made in the field [13], the situation is still not optimal, and universally accepted cut-offs have not been reached. To reduce variation in manual immunoassays and to cope with the increase in the number of referrals, multiplex assays and (semi) automated platforms have been developed [14–17]. Recently, four CSF analytes (Aβ42, Aβ40, t-Tau, and p-Tau) have been implemented on the fully automated Lumipulse G System, which is based on Chemiluminescent Enzyme Immunoassay technology.…”

Section: Introductionmentioning

confidence: 99%

Clinical validation of the Lumipulse G cerebrospinal fluid assays for routine diagnosis of Alzheimer’s disease

et al. 2019

View full text Add to dashboard Cite

BackgroundOngoing efforts within the Alzheimer’s disease (AD) field have focused on improving the intra- and inter-laboratory variability for cerebrospinal fluid (CSF) biomarkers. Fully automated assays offer the possibility to eliminate sample manipulation steps and are expected to contribute to this improvement. Recently, fully automated chemiluminescence enzyme immunoassays for the quantification of all four AD biomarkers in CSF became available. The aims of this study were to (i) evaluate the analytical performance of the Lumipulse G β-Amyloid 1-42 (restandardized to Certified Reference Materials), β-Amyloid 1-40, total Tau, and pTau 181 assays on the fully automated LUMIPULSE G600II; (ii) compare CSF biomarker results of the Lumipulse G assays with the established manual ELISA assays (INNOTEST®) from the same company (Fujirebio); and (iii) establish cut-off values and the clinical performance of the Lumipulse G assays for AD diagnosis.MethodsIntra- and inter-assay variation was assessed in CSF samples with low, medium, and high concentrations of each parameter. Method comparison and clinical evaluation were performed on 40 neurological controls (NC) and 80 patients with a diagnosis of probable AD supported by a follow-up ≥ 3 years and/or positive amyloid PET imaging. A small validation cohort of 10 NC and 20 AD patients was also included to validate the cut-off values obtained on the training cohort.ResultsThe maximal observed intra-assay and inter-assay coefficients of variation (CVs) were 3.25% and 5.50%, respectively. Method comparisons revealed correlation coefficients ranging from 0.89 (for Aβ40) to 0.98 (for t-Tau), with those for Aβ42 (0.93) and p-Tau (0.94) in-between. ROC curve analysis showed area under the curve values consistently above 0.85 for individual biomarkers other than Aβ40, and with the Aβ42/40, Aβ42/t-Tau, and Aβ42/p-Tau ratios outperforming Aβ42. Validation of the cut-off values in the independent cohort showed a sensitivity ranging from 75 to 95% and a specificity of 100%. The overall percentage of agreement between Lumipulse and INNOTEST was very high (> 87.5%).ConclusionsThe Lumipulse G assays show a very good analytical performance that makes them well-suited for CSF clinical routine measurements. The good clinical concordance between the Lumipulse G and INNOTEST assays facilitates the implementation of the new method in routine practice.

show abstract

Section: Introductionmentioning

confidence: 99%

Clinical validation of the Lumipulse G cerebrospinal fluid assays for routine diagnosis of Alzheimer’s disease

et al. 2019

View full text Add to dashboard Cite

show abstract

“…Another complication is that for the Innotest an upward drift of Aβ42 values over time has been shown [8,13–15]. To reduce variation in manual immunoassays, multiplex assays or (semi)automated platforms are being developed [16–19]. The fully automated Elecsys assays for CSF Aβ42, t‐tau CSF, and p‐tau (181P) run on the cobas e 601 analyzer (Roche Diagnostics GmbH, Penzberg, Germany), an instrument commonly used in academic hospital laboratories [20].…”

Section: Introductionmentioning

confidence: 99%

Diagnostic performance of Elecsys immunoassays for cerebrospinal fluid Alzheimer's disease biomarkers in a nonacademic, multicenter memory clinic cohort: The ABIDE project

Willemse

Maurik

Tijms

et al. 2018

Alz & Dem Diag Ass & Dis Mo

View full text Add to dashboard Cite

Introduction We compared the automated Elecsys and manual Innotest immunoassays for cerebrospinal fluid (CSF) Alzheimer's disease biomarkers in a multicenter diagnostic setting. Methods We collected CSF samples from 137 participants in eight local memory clinics. Amyloid β(1–42) (Aβ42), total tau (t-tau), and phosphorylated tau (p-tau) were centrally analyzed with Innotest and Elecsys assays. Concordances between methods were assessed. Results Biomarker results strongly correlated between assays with Spearman's ρ 0.94 for Aβ42, 0.98 for t-tau, and 0.98 for p-tau. Using Gaussian mixture modeling, cohort-specific cut-points were estimated at 1092 pg/mL for Aβ42, 235 pg/mL for t-tau, and 24 pg/mL for p-tau. We found an excellent concordance of biomarker abnormality between assays of 97% for Aβ42 and 96% for both t-tau and p-tau. Discussion The high concordances between Elecsys and Innotest in this nonacademic, multicenter cohort support the use of Elecsys for CSF Alzheimer's disease diagnostics and allow conversion of results between methods.

show abstract

CO₂ cerebrovascular reactivity measured with CBF-MRI in older individuals: Association with cognition, physical function, amyloid, and tau proteins

Sur,

Lin,

et al. 2024

J Cereb Blood Flow Metab

View full text Add to dashboard Cite

Vascular pathology is the second leading cause of cognitive impairment and represents a major contributing factor in mixed dementia. However, biomarkers for vascular cognitive impairment and dementia (VCID) are under-developed. Here we aimed to investigate the potential role of CO2 Cerebrovascular Reactivity (CVR) measured with phase-contrast quantitative flow MRI in cognitive impairment and dementia. Forty-five (69 ± 7 years) impaired (37 mild-cognitive-impairment and 8 mild-dementia by syndromic diagnosis) and 22 cognitively-healthy-control (HC) participants were recruited and scanned on a 3 T MRI. Biomarkers of AD pathology were measured in cerebrospinal fluid. We found that CBF-CVR was lower (p = 0.027) in the impaired (mean±SE, 3.70 ± 0.15%/mmHg) relative to HC (4.28 ± 0.21%/mmHg). After adjusting for AD pathological markers (Aβ42/40, total tau, and Aβ42/p-tau181), higher CBF-CVR was associated with better cognitive performance, including Montreal Cognitive Assessment, MoCA (p = 0.001), composite cognitive score (p = 0.047), and language (p = 0.004). Higher CBF-CVR was also associated with better physical function, including gait-speed (p = 0.006) and time for five chair-stands (p = 0.049). CBF-CVR was additionally related to the Clinical-Dementia-Rating, CDR, including global CDR (p = 0.026) and CDR Sum-of-Boxes (p = 0.015). CBF-CVR was inversely associated with hemoglobin A1C level (p = 0.017). In summary, CBF-CVR measured with phase-contrast MRI shows associations with cognitive performance, physical function, and disease-severity, independent of AD pathological markers.

show abstract

P4‐230: From innotest to the fully automated chemiluminescent b‐amyloid_(1‐42) and total tau assays on the LUMIPULSE^®G instrument series: Taking quantification of Alzheimer's disease CSF biomarkers to the next level

Cited by 4 publications

References 0 publications

Clinical validation of the Lumipulse G cerebrospinal fluid assays for routine diagnosis of Alzheimer’s disease

Clinical validation of the Lumipulse G cerebrospinal fluid assays for routine diagnosis of Alzheimer’s disease

Diagnostic performance of Elecsys immunoassays for cerebrospinal fluid Alzheimer's disease biomarkers in a nonacademic, multicenter memory clinic cohort: The ABIDE project

CO₂ cerebrovascular reactivity measured with CBF-MRI in older individuals: Association with cognition, physical function, amyloid, and tau proteins

Contact Info

Product

Resources

About

P4‐230: From innotest to the fully automated chemiluminescent b‐amyloid(1‐42) and total tau assays on the LUMIPULSE®G instrument series: Taking quantification of Alzheimer's disease CSF biomarkers to the next level

Cited by 4 publications

References 0 publications

Clinical validation of the Lumipulse G cerebrospinal fluid assays for routine diagnosis of Alzheimer’s disease

Clinical validation of the Lumipulse G cerebrospinal fluid assays for routine diagnosis of Alzheimer’s disease

Diagnostic performance of Elecsys immunoassays for cerebrospinal fluid Alzheimer's disease biomarkers in a nonacademic, multicenter memory clinic cohort: The ABIDE project

CO2 cerebrovascular reactivity measured with CBF-MRI in older individuals: Association with cognition, physical function, amyloid, and tau proteins

Contact Info

Product

Resources

About

P4‐230: From innotest to the fully automated chemiluminescent b‐amyloid_(1‐42) and total tau assays on the LUMIPULSE^®G instrument series: Taking quantification of Alzheimer's disease CSF biomarkers to the next level

CO₂ cerebrovascular reactivity measured with CBF-MRI in older individuals: Association with cognition, physical function, amyloid, and tau proteins