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@ARTICLE{Pietschmann:892414,
author = {Pietschmann, Jan and Voepel, Nadja and Voß, Leonie and
Rasche, Stefan and Schubert, Max and Kleines, Michael and
Krause, Hans-Joachim and Shaw, Tamlyn M. and Spiegel, Holger
and Schroeper, Florian},
title = {{D}evelopment of {F}ast and {P}ortable {F}requency
{M}agnetic {M}ixing-{B}ased {S}erological
{SARS}-{C}o{V}-2-{S}pecific {A}ntibody {D}etection {A}ssay},
journal = {Frontiers in microbiology},
volume = {12},
issn = {1664-302X},
address = {Lausanne},
publisher = {Frontiers Media},
reportid = {FZJ-2021-02070},
pages = {643275},
year = {2021},
abstract = {A novel severe acute respiratory syndrome coronavirus-2
(SARS-CoV-2) emerged in China in December 2019, causing an
ongoing, rapidly spreading global pandemic. Worldwide,
vaccination is now expected to provide containment of the
novel virus, resulting in an antibody-mediated immunity. To
verify this, serological antibody assays qualitatively as
well as quantitatively depicting the amount of generated
antibodies are of great importance. Currently available test
methods are either laboratory based or do not have the
ability to indicate an estimation about the immune response.
To overcome this, a novel and rapid serological magnetic
immunodetection (MID) point-of-care (PoC) assay was
developed, with sensitivity and specificity comparable to
laboratory-based DiaSorin Liaison SARS-CoV-2 S1/S2 IgG
assay. To specifically enrich human antibodies against
SARS-CoV-2 in immunofiltration columns (IFCs) from patient
sera, a SARS-CoV-2 S1 antigen was transiently produced in
plants, purified and immobilized on the IFC. Then, an
IgG-specific secondary antibody could bind to the retained
antibodies, which was finally labeled using
superparamagnetic nanoparticles. Based on frequency magnetic
mixing technology (FMMD), the magnetic particles enriched in
IFC were detected using a portable FMMD device. The obtained
measurement signal correlates with the amount of
SARS-CoV-2-specific antibodies in the sera, which could be
demonstrated by titer determination. In this study, a
MID-based assay could be developed, giving qualitative as
well as semiquantitative results of SARS-CoV-2-specific
antibody levels in patient’s sera within 21 min of assay
time with a sensitivity of $97\%$ and a specificity of
$92\%,$ based on the analysis of 170 sera from hospitalized
patients that were tested using an Food and Drug
Administration (FDA)-certified chemiluminescence assay.},
cin = {IBI-3},
ddc = {570},
cid = {I:(DE-Juel1)IBI-3-20200312},
pnm = {523 - Controlling Configuration-Based Phenomena (POF3-523)},
pid = {G:(DE-HGF)POF3-523},
typ = {PUB:(DE-HGF)16},
pubmed = {34025604},
UT = {WOS:000651861700001},
doi = {10.3389/fmicb.2021.643275},
url = {https://juser.fz-juelich.de/record/892414},
}