Product Flyer
SEPSIS AND INFLAMMATION
CYTOMETRY
Complete routine diagnostic kit
for the detection of
Inflammation and Bacterial Sepsis
Leuko64™
Special features
 Prognostic survival marker in SIRS & sepsis
 CD64 is up-regulated within 4 to 6 hours
 Improved sensitivity and specificity over
current laboratory tests (PMN counts, CRP,
ERS) for inflammation (2)

Requires only 50 μL of blood

Less than 60 minutes assay time

For use on flow cytometer

[IVD] |
Applications
(2)
 CD64 is an early-onset marker for inflammatory
responses to infection or tissue injury
(1)
 Clear distinction between inflammation and
conditions like leukemia, pregnancy or steroid
therapy (2)
 Monitoring post-operative and post-
chemotherapy patients, HIV+ patients and
others at risk for infection/sepsis (3)
 Best marker for detection and monitoring sepsis
in young born or neonates
(References on back page)
(4)
Product Flyer
Background information
Inflammation is the complex biological response of vascular tissues
to harmful stimuli, such as pathogens, damaged cells, or irritants.
It is a protective attempt by the organism to remove the injurious
stimuli as well as initiate the healing process for the tissue.
Inflammation is not a synonym for infection. Infection is caused by
an exogenous pathogen, while inflammation is the response of the
organism to the pathogen.
When inflammation overwhelms the host, systemic inflammatory
response syndrome (SIRS) is diagnosed. When it is due to
infection, the term sepsis is applied, with bacteremia being applied
specifically for bacterial sepsis and viremia specifically to viral
sepsis. Vasodilation and organ dysfunction are serious problems
associated with widespread infection that may lead to septic shock
and death. In response to infection or tissue injury, neutrophil
(PMN’s) CD64 expression is rapidly increased within hours by
mediators of inflammation (INF-gamma and G-CSF). CD64 have a
high correlation with presence of infection: sensitivity 90.5 %,
specificity 96.3%, positive predictive value 95.0% and negative
predictive value 92.9%.
References
1. Johannes
J.M.L. Hoffmann,
References
Neutrophil
CD64:
a diagnostic
1. Johannes
J.M.L.
Hoffmann,
marker
for infection
sepsis,
Neutrophil
CD64: and
a diagnostic
Clinmarker
Chem for
Labinfection
Med,
and sepsis,
2009;47(8):903-916.
Clin Chem Lab Med,
2. 2009;47(8):903-916.
B.H. Davis, Neutrophil CD64
Expression
infection
and CD64
2. B.H. in
Davis,
Neutrophil
sepsis,
CLI, October
2006.and
Expression
in infection
3. B.H.
Davis
al, Neutrophil
sepsis,
CLI,etOctober
2006.
CD64
Expression:
3. B.H.
Davis etpotential
al, Neutrophil
diagnostic
indicator ofpotential
acute
CD64 Expression:
inflammation
and therapeutic
diagnostic indicator
of acute
monitor
of interferon-γ
therapy,
inflammation
and therapeutic
Laboratory
Hematology
monitor of
interferon-γ therapy,
1995;1:3-12.
Laboratory Hematology
4. 1995;1:3-12.
Groselj-Grene et al.,
Neutrophil
and monocyte
CD64
4. Groselj-Grene
et al.,
Indexes,
lipopolysaccharideNeutrophil
and monocyte CD64
binding
protein,
procalcitonin and
Indexes,
lipopolysaccharideC-reactive
sepsis of and
binding protein
protein,in
procalcitonin
critically
ill neonates
C-reactive
protein and
in sepsis of
children,
Intensive
Care and
Med,
critically
ill neonates
2009;35:11:1950-1958.
children, Intensive Care Med,
(See front page)
2009;35:11:1950-1958.
(See front page)
Principle of the Leuko64™
The Leuko64™ assay is a flow cytometry product. The assay uses a mixture of three
monoclonal antibodies with specificities to two CD64 clones and a CD163 clone. It includes
a fluorescent beads suspension for instrument calibration and standardization of the
leukocyte CD64 and CD163 expression in human blood. The results of the flow analyze
are being used to calculate the index value with the supported user friendly QuantiCalc
software.
Item
Leuko64™
1
[IVD] |
1
Description
Package size
Product code
The Leuko64™ assay is intended for use in the
measurement of leukocyte and specifically neutrophil
CD64 levels in blood
75 tests
LK-064-75
250 tests
LK-064-250
Product distributed for Trillium Diagnostics, LLC, USA
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[IVD] | in vitro diagnostic medical device. The products are registered as IVD in the countries belonging to the
European Union.