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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
.