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Multicentric comparative assessment of the Bio-Evolution® Toxoplasma gondii detection kit with eight laboratory-developed PCR assays for the molecular diagnosis of congenital toxoplasmosis.
[congenital toxoplasmosis]
Detection
of
Toxoplasma
gondii
in
amniotic
fluid
is
an
essential
tool
for
the
prenatal
diagnosis
of
congenital
toxoplasmosis
and
today
is
essentially
based
upon
PCR
.
Although
some
consensus
is
emerging
,
this
molecular
diagnosis
suffers
from
a
lack
of
standardization
and
an
extreme
diversity
of
laboratory-developed
methods
.
Commercial
kits
for
the
detection
of
T
.
gondii
by
PCR
have
been
recently
developed
and
offer
certain
advantages
;
however
they
must
be
assessed
in
comparison
with
optimized
reference
PCR
assays
.
The
present
multicentric
study
aimed
at
comparing
the
Bio-
Evolution
®
Toxoplasma
gondii
detection
kit
with
laboratory-developed
PCR
assays
set
up
in
eight
proficient
centers
in
France
.
The
study
compared
157
amniotic
fluid
samples
and
found
a
concordance
of
99
%
and
100
%
using
76
T
.
gondii-infected
samples
and
81
uninfected
samples
,
respectively
.
Moreover
,
taking
into
account
the
classification
of
the
European
Research
Network
on
Congenital
Toxoplasmosis
,
the
overall
diagnostic
sensitivity
of
all
assays
was
identical
and
calculated
at
86
%
(
54
/
63
)
;
specificity
was
100
%
for
all
.
Finally
,
the
relative
quantification
results
were
in
good
agreement
between
the
kit
and
the
laboratory-developed
assays
.
The
good
performances
of
this
commercial
kit
are
probably
in
part
linked
to
the
use
of
a
number
of
good
practices
:
detection
in
multiplicate
,
amplification
of
the
repetitive
DNA
target
'
re
p
529
'
,
use
of
an
internal
control
for
the
detection
of
PCR
inhibitors
.
The
only
drawbacks
noted
at
the
time
of
the
study
were
the
absence
of
Uracil-
N-
glycosylase
,
as
well
as
small
defects
in
the
reliability
of
the
production
of
different
reagents
.
Diseases
Validation
Diseases presenting
"small defects in the reliability of the production"
symptom
congenital toxoplasmosis
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