Inter-laboratory harmonization of microsphere immunoassays for SARS-CoV-2 antibody detection in contrived dried blood spots and oral fluids
Microbiology Spectrum,
Год журнала:
2025,
Номер
unknown
Опубликована: Март 25, 2025
ABSTRACT
Dried
blood
spots
(DBS)
and
oral
fluids
(OF)
are
easily
attainable
biospecimen
types
that
enabled
population-scale
antibody
monitoring
for
SARS-CoV-2
exposure
vaccination.
However,
the
degree
to
which
two
different
can
be
used
interchangeably
remains
unclear.
To
address
this
question,
we
generated
contrived
DBS
(cDBS)
OF
(cOF)
from
serum
panels
of
SARS-CoV-2-infected,
vaccinated,
uninfected
individuals.
The
samples
were
evaluated
using
multiplexed
microsphere
immunoassays
(MIAs)
at
institutions.
Intra-laboratory
tests
revealed
near-perfect
agreement
between
cDBS
cOF
N
S
antigens,
as
evidenced
by
κ
=
0.97–1
98%–100%
agreement.
Interlaboratory
comparisons
equally
robust
both
(κ
0.94–0.96;
97.5%–98
%
agreement)
0.98–1.0;
99.0%–100%).
Furthermore,
assays
transferred
labs,
including
methods
reagents,
a
subset
(
n
52)
tested.
Qualitative
concordance
remained
high
0.94–1.0;
97.5%–100%
agreement),
confirming
integrity
is
retained
upon
transfer.
In
summary,
our
results
provide
evidence
across
laboratories
institutions
qualitative
assessment
determinations.
IMPORTANCE
establishment
common
research
clinical
laboratory
methodologies
levels
in
paramount
importance
estimating
immunity
COVID-19
infections
communities
populations.
report,
multiplex
immunoassay
protocols
enable
readily
types,
namely,
dried
(OF),
employed
titers
virus-neutralizing
potential.
Язык: Английский
Inter-laboratory harmonization of microsphere immunoassays for SARS-CoV-2 antibody detection in dried blood spots and oral fluids
Опубликована: Окт. 22, 2024
ABSTRACT
Dried
blood
spots
(DBS)
and
oral
fluids
(OF)
are
easily
attainable
biospecimen
types
that
have
enabled
population
scale
antibody
monitoring
for
SARS-CoV-2
exposure
vaccination.
However,
the
degree
to
which
two
different
can
be
used
interchangeably
remains
unclear.
To
begin
address
this
question,
we
generated
contrived
DBS
(cDBS)
OF
(cOF)
from
serum
panels
infected,
vaccinated,
uninfected
individuals.
The
samples
were
evaluated
using
multiplexed
microsphere
immunoassays
(MIAs)
at
institutions.
Intra-laboratory
tests
revealed
near
perfect
agreement
between
cDBS
cOF
N
S
antigens,
as
evidenced
by
κ
=
0.97-1
98%-100%
agreement.
Inter-laboratory
comparisons
equally
robust
both
(κ
0.94-0.96;
97.5%-98
%
agreement)
0.98
-1.0;
99.0%-100%).
Furthermore,
assays
transferred
labs,
including
methods
reagents,
a
subset
of
(n
52)
tested.
Qualitative
concordance
remained
high
0.94-1.0;
97.5%-100%
agreement),
confirming
integrity
is
retained
upon
transfer.
In
summary,
our
results
provide
evidence
across
laboratories
institutions
qualitative
assessment
determinations.
Язык: Английский