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Prospective evaluation of a rapid nanoparticle-based lateral flow immunoassay (STic Expert(®) HIT) for the diagnosis of heparin-induced thrombocytopenia.
[heparin-induced thrombocytopenia]
A
rapid
lateral
flow
immunoassay
(
LFIA
)
(
STic
Expert
(
®
)
HIT
)
,
recently
developed
for
the
diagnosis
of
heparin-induced
thrombocytopenia
(
HIT
)
,
was
evaluated
in
a
prospective
multicentre
cohort
of
334
consecutive
patients
.
The
risk
of
HIT
was
estimated
by
the
4
Ts
score
as
low
,
intermediate
and
high
in
28
·
7
%
,
61
·
7
%
and
9
·
6
%
of
patients
,
respectively
.
Definite
HIT
was
diagnosed
in
40
patients
(
12
·
0
%
)
with
positive
results
on
both
enzyme-linked
immunosorbent
assay
(
Asserachrom
(
®
)
HPIA
IgG
)
and
serotonin
release
assay
.
The
inter-reader
reproducibility
of
results
obtained
was
excellent
(
kappa
ratio
>
0
·
9
)
.
The
negative
predictive
value
of
LFIA
with
plasma
samples
was
99
·
6
%
with
a
negative
likelihood
ratio
(
LR
)
of
0
·
03
,
and
was
comparable
to
those
of
the
particle
gel
immunoassay
(
H
/
PF
4
-
PaGIA
(
®
)
)
performed
in
124
cases
.
Positive
predictive
value
and
positive
LR
were
44
·
4
%
and
5
·
87
,
respectively
,
and
the
results
were
similar
for
serum
samples
.
The
probability
of
HIT
in
intermediate
risk
patients
decreased
from
11
·
2
%
to
0
·
4
%
when
the
LFIA
result
was
negative
and
increased
to
42
·
5
%
when
it
was
positive
.
In
conclusion
,
the
STic
Expert
(
®
)
HIT
combined
with
the
4
Ts
score
is
a
reliable
tool
to
rule
out
the
diagnosis
of
HIT
.
Diseases
Validation
Diseases presenting
"positive predictive value"
symptom
22q11.2 deletion syndrome
acute rheumatic fever
carcinoma of the gallbladder
cholangiocarcinoma
congenital adrenal hyperplasia
congenital diaphragmatic hernia
congenital toxoplasmosis
cushing syndrome
esophageal adenocarcinoma
esophageal carcinoma
familial mediterranean fever
heparin-induced thrombocytopenia
hodgkin lymphoma, classical
phenylketonuria
thoracic outlet syndrome
typhoid
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