Leuko64
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Neutrophil CD64 expression is rapidly increased both in vitro
and in vivo within hours by mediators of inflammation, such as
interferon-gamma
and G-CSF. The same change is observed in response to documented
infection or tissue injury, thus indicating the measurement of
neutrophil
CD64 expression correlates with the presence of infection or sepsis
in humans. The Leuko64 assay is intended for use in the measurement
of leukocyte and specifically neutrophil CD64 levels in blood.
The Leuko64 assay is available in 2 versions: the original Leuko64
Assay kit, designed for use on most multi-parameter flow cytometers
and the Leuko64 Assay-Hematology Analyzer version, designed for
use on Abbott Diagnostics' Cell-Dyn Sapphire or Cell-Dyn 4000 hematology
analyzers.
The kits contain Reagent A - a cocktail of three monoclonal antibodies
with specificities to CD64 (FITC conjugated) and CD163 (phycoerythrin
conjugated) and Reagent C or C-II - a proprietary flourescent bead
suspension used for instrument calibration and the standardization
of the leukocyte CD64 and CD163 expression on human blood leukocytes.
The flow cytometry version kits also contain Reagent B - a red
cell lysing solution concentrate.
Automated software, co-developed with Verity
Software House, for flow cytometric and Cell-Dyn list mode
data analysis is the key innovative feature of the kit. The QuantiCALC
for Leuko64 software uses iterative cluster finding algorithms
is included in the assay kit.
Both versions of the Leuko64 Assay kits are CE marked as an IVD;
FDA clearance and patents are pending.
The Leuko64 flow cytometry version is available in two sizes:
LK-064-250 (250 tests) and LK-064-75 (75 tests). The Leuko64 Assay
Hematology Analyzer version is available as a 100-test kit.
Key Benefits
- Requires only 50 µL of blood and under one hour of hands-on
time.
- Superior diagnostic evaluation of infection - sensitivity 90.5%,
specificity 96.3%, positive predictive value 95.0%, negative predictive
value 92.9%
- Standardized assay with internal calibrator and
controls.
- Automated user-friendly software allows for excellent reproducibility
(CV < 5%).
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This product is currently available to Europe and the Middle East
through IQ
Products and elsewhere directly from Trillium Diagnostics,
LLC. CONTACT US or use
our ORDER FORM for more
information.
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