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Comparison of three different immunoassays in the diagnosis of heparin-induced thrombocytopenia.
[heparin-induced thrombocytopenia]
Abstract
Background
:
Heparin-induced
thrombocytopenia
(
HIT
)
is
caused
by
platelet
activating
antibodies
that
recognize
platelet
factor
4
/
heparin
(
PF
4
/
H
)
complexes
.
Laboratory
testing
plays
a
key
role
in
the
diagnosis
of
HIT
.
As
functional
assays
are
unfeasible
for
most
clinical
laboratories
,
antigen
binding
assays
are
commonly
used
in
routine
testing
.
However
,
their
low
specificity
leads
to
overdiagnosis
of
HIT
.
Therefore
,
it
is
advisable
to
improve
screening
tests
in
this
setting
.
Methods
:
Blood
samples
from
114
patients
in
whom
HIT
was
suspected
were
investigated
using
a
chemiluminescence
test
(
HemosIL
®
AcuStar
HIT
-IgG
)
,
a
PF
4
/
H
IgG
enzyme
immunoassay
(
Lifecodes
PF
4
IgG
)
,
an
IgG-
specific
lateral
flow
immunoassay
heparin-induced
thrombocytopenia
(
LFI-
HIT
,
STic
Expert
®
HIT
)
and
the
heparin-induced
platelet
aggregation
(
HIPA
)
test
.
Results
:
Twenty
-
nine
(
25
.
4
%
)
out
of
114
subjects
with
suspected
HIT
had
a
positive
HIPA
test
.
None
of
patients
with
a
4
Ts
score
<
4
were
positive
at
HIPA
.
HemosIL
®
AcuStar
HIT
-IgG
showed
the
best
performance
in
term
of
sensitivity
and
specificity
when
used
as
single
test
.
Receiver
operating
characteristic
(
ROC
)
analysis
showed
optimization
of
sensitivity
and
specificity
using
a
cut-off
of
1
.
13
U
/
mL
(
0
.
95
and
0
.
98
,
respectively
)
.
As
an
alternative
approach
,
a
strategy
based
on
screening
samples
by
STic
Expert
®
HIT
and
then
retesting
positive
results
by
Lifecodes
PF
4
IgG
(
cut-off
1
OD
)
or
HemosIL
®
AcuStar
HIT
-IgG
(
cut-off
1
.
3
U
/
mL
)
showed
a
performance
compared
to
a
single
test
approach
by
HemosIL
®
AcuStar
HIT
-IgG
.
Conclusions
:
The
HemosIL
®
AcuStar
HIT
or
a
combinatorial
approach
with
the
STic
Expert
®
HIT
and
the
PF
4
/
H
IgG
enzyme
immunoassay
provide
an
accurate
diagnosis
of
immune
HIT
.