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@ARTICLE{Bannach:1007358,
author = {Bannach, Oliver and Pils, Marlene and Dybala, Alexandra and
Rehn, Fabian and Blömeke, Lara and Bujnicki, Tuyen and
Kraemer-Schulien, Victoria Maria and Hoyer, Wolfgang and
Riesner, Detlev and Willbold, Dieter},
title = {{D}evelopment and implementation of an internal quality
control sample to standardize oligomer-based diagnostics of
{A}lzheimer's disease},
journal = {Diagnostics},
volume = {13},
number = {10},
issn = {2075-4418},
address = {Basel},
publisher = {MDPI},
reportid = {FZJ-2023-02027},
pages = {1702 -},
year = {2023},
abstract = {Protein misfolding and aggregation are pathological
hallmarks of various neurodegenerative diseases. In
Alzheimer’s disease (AD), soluble and toxic amyloid-β
(Aβ) oligomers are biomarker candidates for diagnostics and
drug development. However, accurate quantification of Aβ
oligomers in bodily fluids is challenging because extreme
sensitivity and specificity are required. We previously
introduced surface-based fluorescence intensity distribution
analysis (sFIDA) with single-particle sensitivity. In this
report, a preparation protocol for a synthetic Aβ oligomer
sample was developed. This sample was used for internal
quality control (IQC) to improve standardization, quality
assurance, and routine application of oligomer-based
diagnostic methods. We established an aggregation protocol
for Aβ1–42, characterized the oligomers by atomic force
microscopy (AFM), and assessed their application in sFIDA.
Globular-shaped oligomers with a median size of 2.67 nm were
detected by AFM, and sFIDA analysis of the Aβ1–42
oligomers yielded a femtomolar detection limit with high
assay selectivity and dilution linearity over 5 log units.
Lastly, we implemented a Shewhart chart for monitoring IQC
performance over time, which is another important step
toward quality assurance of oligomer-based diagnostic
methods.},
cin = {IBI-7},
ddc = {610},
cid = {I:(DE-Juel1)IBI-7-20200312},
pnm = {5244 - Information Processing in Neuronal Networks
(POF4-524)},
pid = {G:(DE-HGF)POF4-5244},
typ = {PUB:(DE-HGF)16},
pubmed = {37238187},
UT = {WOS:000998096700001},
doi = {10.3390/diagnostics13101702},
url = {https://juser.fz-juelich.de/record/1007358},
}