medRxiv (Cold Spring Harbor Laboratory),
Journal Year:
2022,
Volume and Issue:
unknown
Published: June 14, 2022
Abstract
Background
We
evaluate
the
diagnostic
performance
of
dried
blood
microsampling
combined
with
a
high-throughput
microfluidic
nano-immunoassay
(NIA)
for
identification
anti-SARS-CoV-2
Spike
IgG
seropositivity.
Methods
conducted
serological
study
among
192
individuals
documented
prior
SARS-CoV-2
infection
and
44
negative
individuals.
Participants
had
long
interval
11
months
since
their
qRT-PCR
positive
test.
Serum
was
obtained
after
venipuncture
tested
an
automated
electrochemiluminescence
S
total
Ig
reference
assay,
commercial
ELISA
anti-S1
index
test
NIA.
109
participants
from
cohort
also
participated
in
capillary
collection
using
three
devices:
Mitra,
repurposed
glucose
strips,
HemaXis.
Samples
were
dried,
shipped
by
regular
mail,
extracted,
measured
Findings
Using
serum
samples,
we
achieve
clinical
sensitivity
98·33%
specificity
97·62%
on
NIA,
affirming
high
NIA
post
infection.
Combining
obtain
95·05%
61·11%
83·16%
HemaXis,
91·49%
HemaXis
extraction,
without
any
drop
specificity.
Interpretation
High
demonstrated
when
testing
micro-volume
samples
which
is
expected
to
facilitate
its
use
large-scale
studies
home-based
sampling
or
collected
field.
Funding
Swiss
National
Science
Foundation
NRP
78
Covid-19
grant
198412
Private
Geneva
University
Hospital.
Research
context
Evidence
before
this
Serological
surveillance
importance
better
understand
evolution
spread
adapt
public
health
measures.
identified
multiple
conducting
such
surveys
decentralized
blood,
facilitating
logistics
reducing
burden
healthcare
facilities.
To
perform
detection
antibodies
at
low-cost,
developed
requires
ultra-low
sample
volumes
minimizes
reagent
consumption.
Added
value
In
showed
possibility
combining
validated
show
good
assay
waning
antibody
titers.
different
device,
namely
implemented
protocol
collection,
shipping,
assay.
The
are
presented
devices.
Implications
all
available
evidence
that
but
combination
microsampling.
Facilitated
increased
convenience
microsampling,
together
low-cost
should
conduction
surveys.
Life,
Journal Year:
2021,
Volume and Issue:
11(11), P. 1125 - 1125
Published: Oct. 22, 2021
To
combat
the
COVID-19
pandemic,
vaccines
against
SARS-CoV-2
are
now
given
to
protect
populations
worldwide.
The
level
of
neutralizing
antibodies
following
vaccination
will
evolve
with
time
and
vary
between
individuals.
Immunoassays
quantifying
immunoglobulins
viral
spike
(S)
protein
in
serum/plasma
have
been
developed,
but
need
for
venous
blood
samples
could
limit
frequency
scale
control
populations.
use
a
quantitative
dried
spot
(DBS)
that
can
be
self-collected
would
simplify
this
monitoring.
objective
study
was
determine
whether
DBS
device
(Capitainer
qDBS
10
µL)
used
combination
an
Elecsys
anti-SARS-CoV-2
S
immunoassay
from
Roche
follow
development
persistence
anti-S
antibodies.
This
carried
out
through
two
clinical
studies.
first
investigated
14
volunteers
who
received
doses
Comirnaty
(Pfizer)
vaccine.
levels
progression
over
post-vaccination
were
studied
three
months.
produced
varied
subjects,
similar
trend
observed.
highly
stimulated
by
second
dose
(×100)
peaked
weeks
later.
antibody
subsequently
decreased
months
later
down
65%.
proved
sufficiently
sensitive
evaluating
immune
status
prolonged
time.
cohort
composed
200
random
patients
chemistry
department
Stockholm.
In
cohort,
we
had
no
information
on
previous
infections
or
vaccination.
Nevertheless,
87%
subjects
0.8
U/mL,
bias
plasma
variable,
as
also
seen
study.
BMC Infectious Diseases,
Journal Year:
2023,
Volume and Issue:
23(1)
Published: July 13, 2023
Population-based
serological
studies
allow
to
estimate
prevalence
of
SARS-CoV-2
infections
despite
a
substantial
number
mild
or
asymptomatic
disease
courses.
This
became
even
more
relevant
for
decision
making
after
vaccination
started.
The
KoCo19
cohort
tracks
the
pandemic
progress
in
Munich
general
population
over
two
years,
setting
it
apart
Europe.Recruitment
occurred
during
initial
wave,
including
5313
participants
above
13
years
from
private
households
Munich.
Four
follow-ups
were
held
at
crucial
times
pandemic,
with
response
rates
least
70%.
Participants
filled
questionnaires
on
socio-demographics
and
potential
risk
factors
infection.
From
Follow-up
2,
information
was
added.
antibody
status
measured
using
Roche
Elecsys®
Anti-SARS-CoV-2
anti-N
assay
(indicating
previous
infection)
anti-S
infection
and/or
vaccination).
allowed
us
distinguish
between
sources
acquired
antibodies.The
estimated
cumulative
sero-prevalence
increased
1.6%
(1.1-2.1%)
May
2020
14.5%
(12.7-16.2%)
November
2021.
Underreporting
respect
official
numbers
fluctuated
testing
policies
capacities,
becoming
factor
than
second
half
Simultaneously,
campaign
against
virus
percentage
having
antibodies,
86.8%
(85.5-87.9%)
developed
Incidence
(BTI)
without
(INS)
differed
(ratio
INS/BTI
2.1,
0.7-3.6).
However,
higher
non-vaccinated
vaccinated
one.
Considering
whole
follow-up
time,
being
born
outside
Germany,
working
high-risk
job
living
area
per
inhabitant
identified
as
infection,
while
other
socio-demographic
health-related
variables
not.
Although
we
obtained
significant
within-household
clustering
cases,
no
further
geospatial
found.Vaccination
coverage
presenting
but
breakthrough
contribute
community
spread.
As
underreporting
stays
can
go
undetected,
so
non-pharmaceutical
measures
are
crucial,
particularly
highly
contagious
strains
like
Omicron.
Viruses,
Journal Year:
2023,
Volume and Issue:
15(7), P. 1574 - 1574
Published: July 18, 2023
Antibody
studies
analyze
immune
responses
to
SARS-CoV-2
vaccination
and
infection,
which
is
crucial
for
selecting
strategies.
In
the
KoCo-Impf
study,
conducted
between
16
June
December
2021,
6088
participants
aged
18
above
from
Munich
were
recruited
monitor
antibodies,
particularly
in
healthcare
workers
(HCWs)
at
higher
risk
of
infection.
Roche
Elecsys®
Anti-SARS-CoV-2
assays
on
dried
blood
spots
used
detect
prior
infections
(anti-Nucleocapsid
antibodies)
indicate
combinations
vaccinations/infections
(anti-Spike
antibodies).
The
anti-Spike
seroprevalence
was
94.7%,
whereas,
anti-Nucleocapsid,
it
only
6.9%.
HCW
status
contact
with
SARS-CoV-2-positive
individuals
identified
as
infection
factors,
while
current
smoking
associated
reduced
risk.
Older
age
correlated
anti-Nucleocapsid
antibody
levels,
decreased
response.
Vaccination
alone
or
combined
led
levels.
Increasing
time
since
second
vaccination,
advancing
age,
cumulative
number
cases
affected
response
over
but
had
no
impact
development/seropositivity.
Due
significantly
faced
by
HCWs
limited
significant
suggested
that
all
require
protection
regardless
individual
traits.
Viruses,
Journal Year:
2024,
Volume and Issue:
16(10), P. 1556 - 1556
Published: Sept. 30, 2024
This
study
analyzes
immune
responses
to
SARS-CoV-2
vaccination
and
infection,
including
asymptomatic
cases,
focusing
on
infection
risks
during
the
Omicron
wave,
particularly
among
high-risk
healthcare
workers.
In
KoCo-Impf
study,
we
monitored
6088
vaccinated
participants
in
Munich
aged
18
above.
From
13
May
31
July
2022,
2351
were
follow-uped.
Logistic
regression
models
evaluated
primary,
secondary,
breakthrough
infections
(BTIs).
Roche
Elecsys
Frontiers in Pediatrics,
Journal Year:
2022,
Volume and Issue:
10
Published: July 6, 2022
Here
we
report
our
results
of
a
multi-center,
open
cohort
study
("COVID-Kids-Bavaria")
investigating
the
distribution
acute
SARS-CoV-2
infections
among
children
and
staff
in
99
daycare
facilities
48
elementary
schools
Bavaria,
Germany.
Overall,
2,568
(1,337
school
children,
1,231
preschool
children)
1,288
adults
(466
teachers,
822
staff)
consented
to
participate
were
randomly
tested
three
consecutive
phases
(September/October
2020,
November/December
March
2021).
In
total,
7,062
throat
swabs
analyzed
for
by
commercial
RT-PCR
kits.
phase
I,
only
one
worker
positive.
II,
was
detected
workers,
two
seven
children.
III,
no
sample
This
corresponds
positive
test
rate
0.05%
0.4%
II
0%
III.
Correlation
PCR
result
with
local-7-day
incidence
values
showed
strong
association
7-day-incidence
more
than
100/100,000
as
compared
<100/100,000
(OR
=
10.3
[1.5-438],
p
<
0.005).
After
antibody
testing
offered
713
participants
schools.
A
seroprevalence
7.7%
(students)
4.5%
(teachers)
determined.
During
initial
waves
pandemic,
risk
correlated
positively
local
7-day
incidence.
Hence,
occurrence
reflected
facilities.
An
increased
transmission
setting
schooling
unlikely.
PLoS ONE,
Journal Year:
2023,
Volume and Issue:
18(3), P. e0283149 - e0283149
Published: March 23, 2023
Objectives
We
evaluate
the
diagnostic
performance
of
dried
blood
microsampling
combined
with
a
high-throughput
microfluidic
nano-immunoassay
(NIA)
for
identification
anti-SARS-CoV-2
Spike
IgG
seropositivity.
Methods
conducted
serological
study
among
192
individuals
documented
prior
SARS-CoV-2
infection
and
44
negative
individuals.
Participants
had
long
interval
11
months
since
their
qRT-PCR
positive
test.
Serum
was
obtained
after
venipuncture
tested
an
automated
electrochemiluminescence
S
total
Ig
reference
assay,
commercial
ELISA
anti-S1
index
test
NIA.
In
addition,
109
participants
from
cohort
participated
in
capillary
collection
using
three
devices:
Mitra,
repurposed
glucose
strips,
HemaXis.
Samples
were
dried,
shipped
by
regular
mail,
extracted,
measured
Results
Using
serum
samples,
we
achieve
clinical
sensitivity
98·33%
specificity
97·62%
on
NIA,
affirming
high
NIA
post
infection.
Combining
obtain
95·05%
61·11%
83·16%
HemaXis,
91·49%
HemaXis
extraction,
without
any
drop
specificity.
Discussion
High
demonstrated
when
testing
micro-volume
samples
which
is
expected
to
facilitate
its
use
large-scale
studies
home-based
sampling
or
collected
field.
Biochemistry and Biophysics Reports,
Journal Year:
2023,
Volume and Issue:
34, P. 101479 - 101479
Published: April 25, 2023
Dried
blood
spots
(DBS)
provide
easy
handling
and
are
thus
a
beneficial
tool
for
data
collection,
e.g.
epidemiological
studies.
The
suitability
of
DBS
the
assessment
antibodies
against
severe
acute
respiratory
syndrome
coronavirus
2
(SARS-CoV-2)
was
analyzed
with
regards
to
use
in
future
studies
addressing
seroprevalence
population.
121
volunteers
gave
venous
sample
capillary
samples
on
two
cards
(PerkinElmer
Ahlstrom-Munksjö)
via
self-sampling
under
supervision.
All
were
using
Anti-SARS-CoV-2
ELISA
(IgG)
NCP
from
EUROIMMUN
performed
EUROLabWorkstation
ELISA.
Correlation
coefficients
between
results
based
different
sampling
methods
calculated.
Results
analysis
SARS-CoV-2
IgG
S1
highly
correlated
serum
values
(r
=
0.96).
In
addition,
calculation
phi
coefficient
showed
no
significant
difference
qualitative
both
(rφ
0.98-1.0).
Further
eluates
after
prolonged
storage
6-8
h
also
high
correlation
0.97
r
0.93,
respectively).
study
indicate
NCP.
For
eluate,
stability
measurement
can
be
assumed.
Scientific Reports,
Journal Year:
2022,
Volume and Issue:
12(1)
Published: Feb. 3, 2022
At-home
sampling
is
key
to
large
scale
seroprevalence
studies.
Dried
blood
spot
(DBS)
self-sampling
removes
the
need
for
medical
personnel
specimen
collection
but
facilitates
referral
an
appropriately
accredited
laboratory
accurate
sample
analysis.
To
establish
a
highly
sensitive
and
specific
antibody
assay
that
would
facilitate
prevalence
vaccine-response
Paired
sera
DBS
eluates
collected
from
439
sero-positive,
382
sero-negative
individuals
34
vaccine
recipients
were
assayed
by
capture
ELISAs
IgG
IgM
SARS-CoV-2.
combined
on
achieved
diagnostic
sensitivity
of
97.9%
(95%CI
96.6
99.3)
specificity
99.2%
(95%
CI
98.4
100)
compared
serum,
displaying
limits
detection
equivalent
23
10
WHO
IU/ml,
respectively.
A
strong
correlation
(r
=
0.81)
was
observed
between
serum
reactivities.
Reactivity
remained
stable
with
samples
deliberately
rendered
inadequate,
(p
0.234)
when
accidentally
damaged
or
'invalid'.
All
sero-positive.
This
provides
secure
method
comparable
serum.
The
feasibility
testing
in
sero-prevalence
studies
monitoring
post-vaccine
responses
confirmed,
offering
robust
reliable
tool
serological
at
population
level.