BMJ Open,
Journal Year:
2023,
Volume and Issue:
13(1), P. e067591 - e067591
Published: Jan. 1, 2023
Rapid
antigen
tests
have
been
used
to
prevent
the
spread
of
COVID-19;
however,
there
concerns
about
their
decreased
sensitivity
Omicron
variant.
In
this
study,
we
assessed
and
specificity
rapid
test
compared
with
PCR
among
players
staff
members
Japan
Professional
Football
League
clubs.
Furthermore,
evaluated
relationship
between
duration
from
onset
symptoms
testing
or
vaccine
status.This
was
a
retrospective
observational
study.We
656
results
both
for
COVID-19
using
samples
collected
on
same
day
12
January
2
March
2022,
during
variant
outbreak
in
Japan.The
0.63
(95%
CI:
0.53
0.73)
0.998
0.995
1.000).
There
were
no
significant
associations
(including
asymptomatic
cases
category)
vaccination
status
(p>0.05)
small
effect
sizes
(Cramer's
V
φ:
≤0.22).Even
outbreak,
did
not
depend
testing.
The Lancet Infectious Diseases,
Journal Year:
2023,
Volume and Issue:
23(8), P. 922 - 932
Published: March 28, 2023
BackgroundAntigen
lateral
flow
devices
(LFDs)
have
been
widely
used
to
control
SARS-CoV-2.
We
aimed
improve
understanding
of
LFD
performance
with
changes
in
variant
infections,
vaccination,
viral
load,
and
use,
the
detection
infectious
individuals.MethodsIn
this
diagnostic
study,
paired
RT-PCR
test
results
were
prospectively
collected
from
asymptomatic
symptomatic
participants
UK
between
Nov
4,
2020,
March
21,
2022,
support
National
Health
Service
(NHS)
England's
Test
Trace
programme.
The
LFDs
evaluated
Innova
SARS-CoV-2
Antigen
Rapid
Qualitative
Test,
Orient
Gene
Covid-19
(Antigen)
Self-Test,
Acon
Flowflex
(Self-Testing).
across
various
community
testing
settings,
including
predeployment
sites,
routine
centres,
homes,
schools,
universities,
workplaces,
targeted
testing,
health-care
workers.
multivariable
logistic
regression
analyse
sensitivity
specificity
using
as
a
reference
standard,
adjusting
for
manufacturer,
setting,
age,
sex,
assistance,
symptom
status,
vaccination
variant.
contact
tracing
data
NHS
(Jan
1,
2021,
Jan
11,
2022)
estimate
proportion
transmitting
index
patients
(with
≥1
RT-PCR-positive
or
LFD-positive
contact)
potentially
detectable
by
(specifically
Innova,
most
LFD)
time,
accounting
variant,
status.FindingsWe
assessed
75
382
pairs
tests.
Of
these,
4131
(5·5%)
RT-PCR-positive.
versus
was
63·2%
(95%
CI
61·7–64·6)
99·71%
99·66–99·74).
Increased
load
independently
associated
being
positive
(adjusted
odds
ratio
[aOR]
2·85
[95%
2·66–3·06]
per
1
log10
copies
mL
increase;
p<0·0001).
There
no
evidence
that
differed
delta
(B.1.617.2)
infections
alpha
(B.1.1.7)
pre-alpha
(B.1.177)
(aOR
1·00
[0·69–1·45];
p=0·99),
whereas
omicron
(BA.1
BA.2)
appeared
more
likely
be
1·63
[1·02–2·59];
p=0·042).
Sensitivity
higher
(68·7%
66·9–70·4])
than
(52·8%
[50·1–55·4]).
Among
347
374
unique
probable
onward
transmission,
78·3%
75·3–81·2)
estimated
(Innova),
mostly
stable
time
successive
variants.
Overall,
lower
(57·6%
[53·6–61·9])
(79·7%
[76·7–82·5]).InterpretationLFDs
remained
able
detect
throughout
vaccine
roll-out
different
can
transmit
others
reduce
risk
transmission.
However,
is
individuals
individuals.FundingUK
Security
Agency,
Government
Department
Social
Care,
Institute
Research
(NIHR)
Protection
Unit
Healthcare
Associated
Infections
Antimicrobial
Resistance,
University
Oxford
NIHR
Biomedical
Centre.
JAMA Network Open,
Journal Year:
2022,
Volume and Issue:
5(10), P. e2238354 - e2238354
Published: Oct. 25, 2022
Importance
The
SARS-CoV-2
Omicron
subvariant,
BA.2,
may
be
less
severe
than
previous
variants;
however,
confounding
factors
make
interpreting
the
intrinsic
severity
challenging.
Objective
To
compare
adjusted
risks
of
mortality,
hospitalization,
intensive
care
unit
admission,
and
invasive
ventilation
between
BA.2
subvariant
Delta
variants,
after
accounting
for
multiple
confounders.
Design,
Setting,
Participants
This
was
a
retrospective
cohort
study
that
applied
an
entropy
balancing
approach.
Patients
in
multicenter
inpatient
outpatient
system
New
England
with
COVID-19
March
3,
2020,
June
20,
2022,
were
identified.
Exposures
Cases
assigned
as
being
exposed
to
(B.1.617.2)
variant,
(B.1.1.529)
or
lineage
subvariants.
Main
Outcomes
Measures
primary
outcome
planned
before
analysis
risk
30-day
mortality.
Secondary
outcomes
included
ventilation,
admissions.
Results
Of
102
315
confirmed
cases
(mean
[SD]
age,
44.2
[21.6]
years;
63
482
women
[62.0%]),
20
770
labeled
52
605
B.1.1.529
28
940
Patient
excluded
if
they
occurred
outside
prespecified
temporal
windows
associated
variants
had
minimal
longitudinal
data
Mass
General
Brigham
COVID-19.
Mortality
rates
0.7%
(B.1.617.2),
0.4%
(B.1.1.529),
0.3%
(BA.2).
odds
ratio
mortality
from
variant
compared
subvariants
2.07
(95%
CI,
1.04-4.10)
original
2.20
1.56-3.11).
For
all
outcomes,
significantly
variants.
Conclusions
Relevance
In
this
study,
having
accounted
variety
found
intrinsically
both
With
respect
these
profile
appears
diminishing
taking
into
account
various
including
therapeutics,
vaccinations,
prior
infections.
Microbiology Spectrum,
Journal Year:
2022,
Volume and Issue:
10(4)
Published: Aug. 8, 2022
Sensitivity
for
detecting
Omicron-BA.1
shows
high
heterogenicity
between
Ag-RDTs,
necessitating
a
careful
consideration
when
using
these
tests
to
guide
infection
prevention
measures.
Analytical
and
retrospective
testing
is
proxy
timely
solution
generate
rapid
performance
data,
but
it
not
replacement
clinical
evaluations,
which
are
urgently
needed.
Biological
technical
reasons
detection
failure
by
some
Ag-RDTs
need
be
further
investigated.
BMJ,
Journal Year:
2022,
Volume and Issue:
unknown, P. e071215 - e071215
Published: Sept. 14, 2022
To
assess
the
performance
of
rapid
antigen
tests
with
unsupervised
nasal
and
combined
oropharyngeal
self-sampling
during
omicron
period.Prospective
cross
sectional
diagnostic
test
accuracy
study.Three
public
health
service
covid-19
sites
in
Netherlands,
21
December
2021
to
10
February
2022.6497
people
symptoms
aged
≥16
years
presenting
for
testing.Participants
had
a
swab
sample
taken
reverse
transcription
polymerase
chain
reaction
(RT-PCR,
reference
test)
received
one
perform
using
either
(during
emergence
omicron,
when
accounted
>90%
infections,
phase
1)
or
subsequent
(phase
2;
>99%
infections).
The
evaluated
were
Flowflex
(Acon
Laboratories;
1
only),
MPBio
(MP
Biomedicals),
Clinitest
(Siemens-Healthineers).The
main
outcomes
sensitivity,
specificity,
positive
negative
predictive
values
each
self-test,
RT-PCR
testing
as
standard.During
1,
45.0%
(n=279)
participants
group,
29.1%
(n=239)
35.4%
((n=257)
group
confirmatory
testers
(previously
tested
by
self-test
at
own
initiative).
Overall
sensitivities
79.0%
(95%
confidence
interval
74.7%
82.8%)
Flowflex,
69.9%
(65.1%
74.4%)
MPBio,
70.2%
(65.6%
74.5%)
Clinitest.
Sensitivities
substantially
higher
(93.6%,
83.6%,
85.7%,
respectively)
than
those
who
other
reasons
(52.4%,
51.5%,
49.5%,
respectively).
decreased
from
87.0%
80.9%
(P=0.16
χ2
test),
80.0%
73.0%
(P=0.60),
83.1%
70.3%
(P=0.03),
respectively,
transitioning
accounting
29%
infections
>95%
infections.
During
2,
53.0%
(n=288)
44.4%
(n=290)
testers.
83.0%
(78.8%
86.7%)
77.3%
(72.9%
81.2%)
When
was
compared
self-sampling,
found
be
slightly
(87.4%
86.1%,
(69.3%
59.9%,
respectively).Sensitivities
three
but
only
statistically
significant
appeared
influenced
proportion
improved
after
addition
self-sampling.
A
result
justifies
prompt
self-isolation
without
need
testing.
Individuals
should
adhere
general
preventive
measures
because
false
cannot
ruled
out.
Manufacturers
may
consider
extending
their
instructions
use
include
manufacturers
evaluating
this
well.
Clinical Infectious Diseases,
Journal Year:
2023,
Volume and Issue:
78(7), P. e350 - e384
Published: Jan. 23, 2023
Immunoassays
designed
to
detect
SARS-CoV-2
protein
antigens
(Ag)
are
commonly
used
diagnose
COVID-19.
The
most
widely
tests
lateral
flow
assays
that
generate
results
in
approximately
15
minutes
for
diagnosis
at
the
point-of-care.
Higher
throughput,
laboratory-based
Ag
have
also
been
developed.
number
of
commercially
available
detection
has
increased
rapidly,
as
COVID-19
diagnostic
literature.
Infectious
Diseases
Society
America
(IDSA)
convened
an
expert
panel
perform
a
systematic
review
literature
and
develop
best-practice
guidance
related
testing.
This
guideline
is
update
third
series
frequently
updated
guidelines
developed
by
IDSA.
IDSA's
goal
was
evidence-based
recommendations
or
suggestions
assist
clinicians,
clinical
laboratories,
patients,
public
health
authorities,
administrators,
policymakers
decisions
optimal
use
both
medical
nonmedical
settings.
A
multidisciplinary
infectious
diseases
microbiologists,
experts
identified
prioritized
questions
tests.
relevant,
peer-reviewed
published
conducted
through
1
April
2022.
Grading
Recommendations
Assessment,
Development,
Evaluation
(GRADE)
methodology
assess
certainty
evidence
make
testing
recommendations.
made
10
address
symptomatic
asymptomatic
individuals
single
versus
repeat
strategies.
US
Food
Drug
Administration
(FDA)
with
Emergency
Use
Authorization
(EUA)
high
specificity
low
moderate
sensitivity
compared
nucleic
acid
amplification
(NAAT).
test
dependent
on
presence
absence
symptoms
and,
timing
after
symptom
onset.
In
cases,
positive
can
be
acted
upon
without
confirmation.
Results
point-of-care
comparable
those
testing,
observed
unobserved
self-collection
specimens
yields
similar
results.
Modeling
suggests
increases
once,
but
no
empirical
data
were
inform
this
question.
Based
these
observations,
rapid
RT-PCR
NAAT
remain
methods
choice
diagnosing
infection.
However,
when
timely
molecular
not
readily
logistically
infeasible,
helps
identify
Data
insufficient
recommendation
about
utility
guide
release
patients
from
isolation.
overall
quality
supporting
graded
very
moderate.
Reviews in Medical Virology,
Journal Year:
2023,
Volume and Issue:
33(2)
Published: Feb. 15, 2023
Abstract
The
Omicron
variant
of
concern
has
a
high
level
mutations
in
different
genes
that
raised
awareness
about
the
performance
immunological
products
such
as
vaccines
and
antigen
detection
kits.
In
this
systematic
review
meta‐analysis,
we
investigated
whether
had
significant
influence
on
rapid
test
(RAT)
comparison
to
PCR.
We
registered
meta‐analysis
PROSPERO
with
registration
number
CRD42022355510.
searched
PubMed,
Scopus,
Embase,
Web
Science
databases
systematically
1
August
2022.
After
article
screening,
assessed
quality
included
studies
based
JBI
checklist.
Following
data
extraction,
performed
using
R
software.
18
qualified
articles
presenting
sufficient
RATs
RT‐PCR
infections.
pooled
specificity
sensitivity
were
1.000
(0.997–1.000)
0.671
(0.595–0.721),
respectively.
FDA‐approved
kits
showed
better
than
WHO‐approved
ones
0.728
(0.620–0.815).
use
nasal
swabs
higher
compared
nasopharyngeal
swabs.
for
samples
CT‐value
>25
was
0.108
(0.048–0.227).
Rapid
tests
show
impaired
COVID‐19
diagnosis
when
is
circulating,
particularly
low
viral
loads.
JAMA Network Open,
Journal Year:
2023,
Volume and Issue:
6(2), P. e230982 - e230982
Published: Feb. 28, 2023
Importance
Breath
analysis
has
been
explored
as
a
noninvasive
means
to
detect
COVID-19.
However,
the
impact
of
emerging
variants
SARS-CoV-2,
such
Omicron,
on
exhaled
breath
profile
and
diagnostic
accuracy
is
unknown.
Objective
To
evaluate
accuracies
detecting
patients
with
COVID-19
when
SARS-CoV-2
Delta
Omicron
were
most
prevalent.
Design,
Setting,
Participants
This
study
included
cohort
who
had
positive
negative
test
results
for
using
reverse
transcriptase
polymerase
chain
reaction
between
April
2021
May
2022,
which
covers
period
variant
was
overtaken
by
major
variant.
Patients
enrolled
through
intensive
care
units
emergency
department
at
University
Michigan
Health
System.
Patient
analyzed
portable
gas
chromatography.
Main
Outcomes
Measures
Different
sets
VOC
biomarkers
identified
that
distinguished
(SARS-CoV-2
variants)
non–COVID-19
illness.
Results
Overall,
205
samples
from
167
adult
analyzed.
A
total
77
(mean
[SD]
age,
58.5
[16.1]
years;
41
[53.2%]
male
patients;
13
[16.9%]
Black
59
[76.6%]
White
patients)
COVID-19,
91
54.3
[17.1]
43
[47.3%]
11
[12.1%]
76
[83.5%]
Several
over
multiple
days.
Among
94
samples,
in
infected
or
other
variants,
53
2022
variant,
based
State
US
Centers
Disease
Control
Prevention
surveillance
data.
Four
found
distinguish
(Delta
illness
an
94.7%.
dropped
substantially
82.1%
these
applied
new
(accuracy,
90.9%).
earlier
91.5%
(all
vs
90.2%
accuracy.
Conclusions
Relevance
The
findings
this
suggest
promise
detection.
similar
rapid
antigen
testing,
emergence
poses
challenges.
warrant
additional
evaluation
how
overcome
challenges
use
improve
diagnosis
patients.
The Lancet Microbe,
Journal Year:
2024,
Volume and Issue:
5(6), P. e538 - e546
Published: May 14, 2024
Evolving
SARS-CoV-2
variants
and
changing
levels
of
pre-existing
immunity
require
re-evaluation
antigen-detecting
rapid
diagnostic
test
(Ag-RDT)
performance.
We
investigated
possible
associations
between
Ag-RDT
sensitivity
various
potential
influencing
factors,
such
as
immunisation
status
viral
variant,
in
symptomatic
hospital
employees.