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Trillium Diagnostics 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 designed for use on most multi-parameter flow cytometers.

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 kits also contain Reagent B - a red cell lysing solution concentrate.

Automated software, co-developed with Verity Software House, for flow cytometric 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.

Leuko64 Assay kits are CE marked as an IVD; FDA clearance and patents are pending.

The Leuko64 kit is available in two sizes: LK-064-250 (250 tests) and LK-064-75 (75 tests).

 

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%).