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Multicenter clinical evaluation of the illumigene group A Streptococcus DNA amplification assay for detection of group A Streptococcus from pharyngeal swabs.
[acute rheumatic fever]
Acute
pharyngitis
is
a
nonspecific
symptom
that
can
result
from
a
number
of
viral
or
bacterial
infections
.
For
most
etiologies
,
symptoms
are
self-
limited
and
resolve
without
lasting
effects
;
however
,
pharyngitis
resulting
from
infection
with
Streptococcus
pyogenes
(
a
group
A
Streptococcus
[
GAS
]
)
can
be
associated
with
serious
sequelae
,
including
acute
rheumatic
fever
and
acute
glomerulonephritis
.
Rapid
accurate
detection
of
GAS
in
pharyngeal
specimens
from
individuals
suffering
from
pharyngitis
aids
in
the
management
and
selection
of
antibiotic
therapy
for
these
patients
.
A
total
of
796
pharyngeal
swabs
were
collected
at
three
separate
clinical
centers
.
Each
specimen
was
analyzed
using
the
illumigene
group
A
strep
DNA
amplification
assay
(
Meridian
Bioscience
Inc
.
,
Cincinnati
,
OH
)
.
To
confirm
GAS
identification
,
the
results
were
compared
to
those
from
direct
and
extracted
culture
methods
using
Gram
staining
and
a
GAS
-
specific
latex
agglutination
test
.
Discrepant
results
were
resolved
using
an
alternative
nucleic
acid
amplification
test
.
The
prevalence
of
culture-detected
GAS
in
this
study
was
12
.
8
%
(
102
/
796
specimens
)
.
The
illumigene
assay
detected
GAS
in
74
/
74
direct
culture-
positive
specimens
(
100
%
sensitivity
)
and
100
/
102
extracted
culture-
positive
specimens
(
98
.
0
%
sensitivity
)
.
GAS
was
detected
by
the
illumigene
assay
in
an
additional
42
specimens
that
were
direct
culture
negative
(
94
.
2
%
specificity
)
and
16
specimens
that
were
extracted
culture
negative
(
97
.
7
%
specificity
)
.
Discrepant
analysis
using
an
alternative
molecular
assay
detected
GAS
nucleic
acid
in
13
/
16
(
81
.
3
%
)
false-
positive
specimens
and
1
/
2
false-negative
specimens
,
resulting
in
a
final
sensitivity
of
99
.
0
%
and
a
specificity
of
99
.
6
%
for
the
detection
of
GAS
in
pharyngeal
swabs
using
the
illumigene
assay
.
Diseases
Validation
Diseases presenting
"positive specimens"
symptom
acute rheumatic fever
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