P1–166: Inter‐laboratory variation when using a unified test procedure for INNO‐BIA AlzBio3

Vandijck, Manu; Kuwano, Ryozo; Waligórska, Teresa; Smet, Samantha De; Tsukie, Tamao; Verdoodt, L; Deleersnijder, Willy; Trojanowski, John Q.; Iwatsubo, Takeshi; Shaw, Leslie A.

doi:10.1016/j.jalz.2013.05.389

Cited by 6 publications

(5 citation statements)

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“…Aβ42, t-tau, and p-tau were measured using the multiplex xMAP Luminex platform with INNO-BIA AlzBio3 kits (Fujirebio Europe, Ghent, Belgium). To minimize the effects of analytical variability on the results [61], CSF analysis was performed following the manufacturer’s instructions and unified standard procedures, as previously described [62,63]. We determined the analytical precision using nine pooled CSFs and found that the mean (SD) between-run precision (percent coefficient of variation (%CV) through five runs) for CSF Aβ42, t-tau and p-tau was 9.1 (2.0), 10.9 (2.5), and 10.7 (6.2) %.…”

Section: Methodsmentioning

confidence: 99%

Clinical and Biomarker Characteristics According to Clinical Spectrum of Alzheimer’s Disease (AD) in the Validation Cohort of Korean Brain Aging Study for the Early Diagnosis and Prediction of AD

Hwang

Jeong

Yoon

et al. 2019

JCM

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We aimed to present the study design of an independent validation cohort from the Korean Brain Aging Study for the Early Diagnosis and Prediction of Alzheimer’s disease (AD) (KBASE-V) and to investigate the baseline characteristics of the participants according to the AD clinical spectrum. We recruited 71 cognitively normal (CN) participants, 96 with subjective cognitive decline (SCD), 72 with mild cognitive impairment (MCI), and 56 with AD dementia (ADD). The participants are followed for three years. The Consortium to Establish a Registry for AD scores was significantly different between all of the groups. The logical memory delayed recall scores were significantly different between all groups, except between the MCI and ADD groups. The Mini-Mental State Examination score, hippocampal volume, and cerebrospinal fluid (CSF) amyloid-β42 level were significant difference among the SCD, MCI, and ADD groups. The frequencies of participants with amyloid pathology according to PET or CSF studies were 8.9%, 25.6%, 48.3%, and 90.0% in the CN, SCD, MCI, and ADD groups, respectively. According to ATN classification, A+/T+/N+ or A+/T+/N− was observed in 0%, 15.5%, 31.0%, and 78.3% in the CN, SCD, MCI, and ADD groups, respectively. The KBASE-V showed a clear difference according to the AD clinical spectrum in neuropsychological tests and AD biomarkers.

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Section: Methodsmentioning

confidence: 99%

Clinical and Biomarker Characteristics According to Clinical Spectrum of Alzheimer’s Disease (AD) in the Validation Cohort of Korean Brain Aging Study for the Early Diagnosis and Prediction of AD

Hwang

Jeong

Yoon

et al. 2019

JCM

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“…The procedure is described elsewhere [16,17]. To reduce the effects of sources of variability on the results [18], CSF analysis was followed by the manufacturer's instructions and standard of procedures that were previously described [19,20].…”

Section: Blinded Visual Interpretationmentioning

confidence: 99%

Clinical significance of focal ß-amyloid deposition measured by 18F-flutemetamol PET

et al. 2020

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Background: Although amyloid PET of typical Alzheimer's disease (AD) shows diffuse ß-amyloid (Aß) deposition, some patients show focal deposition. The clinical significance of this focal Aß is not well understood. We examined the clinical significance of focal Aß deposition in terms of cognition as well as Aß and tau cerebrospinal fluid (CSF) levels. We further evaluated the order of Aß accumulation by visual assessment. Methods: We included 310 subjects (125 cognitively unimpaired, 125 mild cognitive impairment, and 60 AD dementia) from 9 referral centers. All patients underwent neuropsychological tests and 18 F-flutemetamol (FMM) PET. Seventy-seven patients underwent CSF analysis. Each FMM scan was visually assessed in 10 regions (frontal, precuneus and posterior cingulate, lateral temporal, parietal, and striatum of each hemisphere) and was classified into three groups: No-FMM, Focal-FMM (FMM uptake in 1-9 regions), and Diffuse-FMM (FMM uptake in all 10 regions). Results: 53/310 (17.1%) subjects were classified as Focal-FMM. The cognitive level of the Focal-FMM group was better than that of Diffuse-FMM group and worse than that of No-FMM group. Among the Focal-FMM group, those who had FMM uptake to a larger extent or in the striatum had worse cognitive levels. Compared to the Diffuse-FMM group, the Focal-FMM group had a less AD-like CSF profile (increased Aß42 and decreased t-tau, t-tau/Aß42). Among the Focal-FMM group, Aß deposition was most frequently observed in the frontal (62.3%) and least frequently observed in the striatum (43.4%) and temporal (39.6%) regions. Conclusions: We suggest that focal Aß deposition is an intermediate stage between no Aß and diffuse Aß deposition. Furthermore, among patients with focal Aß deposition, those who have Aß to a larger extent and striatal involvement show clinical features close to diffuse Aß deposition. Further longitudinal studies are needed to evaluate the disease progression of patients with focal Aß deposition.

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“…In this pilot study, we observed a strong correlation of concentrations for each analyte between the participating centers (R 2 > 0.95; linear regression: center versus overall center mean) and average total interlaboratory variability for 10 pools of CSF (variability components “run” and “lab”) over eight runs were 16.5% for t-tau, 10.9% for Aβ 1–42 , and 9.2% for p-tau 181 . Therefore, we are convinced that the implementation of a unified SOP, careful documentation of critical parameters of the test procedure, and the rigorous adherence to detailed test instructions can result in improved CSF analyte concentration reproducibility across laboratories [29]. In addition, the experience of trained personnel who are very familiar with this complex procedure is essential to decrease variability.…”

Section: Qualification Of the Analytical Performance Of Csf Biomarmentioning

confidence: 99%

The Alzheimer's Disease Neuroimaging Initiative 2 Biomarker Core: A review of progress and plans

Kang

Korecka

Figurski

et al. 2015

Alzheimer's & Dementia

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Introduction We describe Alzheimer’s Disease Neuroimaging Initiative (ADNI) Biomarker Core progress including: the Biobank; cerebrospinal fluid (CSF) amyloid beta (Aβ1–42), t-tau, and p-tau181 analytical performance, definition of Alzheimer’s disease (AD) profile for plaque, and tangle burden detection and increased risk for progression to AD; AD disease heterogeneity; progress in standardization; and new studies using ADNI biofluids. Methods Review publications authored or coauthored by ADNI Biomarker core faculty and selected non-ADNI studies to deepen the understanding and interpretation of CSF Aβ1–42, t-tau, and p-tau181 data. Results CSFAD biomarker measurements with the qualified AlzBio3 immunoassay detects neuropathologic AD hallmarks in preclinical and prodromal disease stages, based on CSF studies in non-ADNI living subjects followed by the autopsy confirmation of AD. Collaboration across ADNI cores generated the temporal ordering model of AD biomarkers varying across individuals because of genetic/environmental factors that increase/decrease resilience to AD pathologies. Discussion Further studies will refine this model and enable the use of biomarkers studied in ADNI clinically and in disease-modifying therapeutic trials.

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P1–166: Inter‐laboratory variation when using a unified test procedure for INNO‐BIA AlzBio3

Cited by 6 publications

References 0 publications

Clinical and Biomarker Characteristics According to Clinical Spectrum of Alzheimer’s Disease (AD) in the Validation Cohort of Korean Brain Aging Study for the Early Diagnosis and Prediction of AD

Clinical and Biomarker Characteristics According to Clinical Spectrum of Alzheimer’s Disease (AD) in the Validation Cohort of Korean Brain Aging Study for the Early Diagnosis and Prediction of AD

Clinical significance of focal ß-amyloid deposition measured by 18F-flutemetamol PET

The Alzheimer's Disease Neuroimaging Initiative 2 Biomarker Core: A review of progress and plans

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