Leuko64™ kit

Routine diagnosis of inflammation and bacterial sepsis

Introduction

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.

An organism can escape the confines of the immediate tissue via the circulatory system or lymphatic system, where it may spread to other parts of the body. If an organism is not contained by the actions of acute inflammation it may gain access to the lymphatic system via nearby lymph vessels.

When inflammation overwhelms the host, systemic inflammatory response syndrome 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.

The Leuko64™ assay is innovative and highly specific concept intended for use in the measurement of leukocyte neutrophil CD64 levels, which increase in response to infection or tissue injury
With the Leuko64™ kit a procedure for the diagnosis of early-onset of inflammation and sepsis is available, that could direct an effective therapy at the right time and save unnecessary spending for critically ill patients.

Download more information

Download Leuko64 kit INSTRUCTION FILM

http://www.youtube.com/watch?v=fYAUm5QZWr8

Clinical applications

• Screening for infection severity in outpatients and hospitalized patients including neonates.
• Therapeutic monitor of antibiotic response in infection.
• Monitoring post-operative and post-chemotherapy patients, HIV⁺ patients, and others at risk for infection/sepsis

Special features

• CD64 is an early-onset marker for inflammatory responses to infection or tissue injury.
• CD64 expression in PMNs increases rapidly within hours of inflammation Clear distinction between inflammation and conditions like leukemia, pregnancy or steroid therapy
• Standardized assay with internal calibrator and controls
• High correlation with presence of infection
  
  - Sensitivity 90.5%
  - Specificity 96.3%
  - Positive predictive value 95.0%
  - Negative predictive value 92.9%
  

Kit format

• Available in 2 different formats.
  - Flow cytometer (75 tests and 250 tests) (code: LK-064-75/250)
  - CelDyn Sapphire hematology analyzer (100 tests) (code: LK-64H-100)
• Requires only 50 ul of blood and under 1 hour of hands-on time
• RBC lysing solution (not in the hematology analyzer version)
• CD64 FITC (2 different clones)
• CD163 R-PE
• Starfire Red absolute counting beads (in FITC and R-PE) used for instrument calibration and standardization of the leukocyte CD64 and CD163 expression in human blood.
• Specialized software aids in the automated data analysis and reporting of the data.

Foreign language:
Leuko64 75 - 250 (ES - FR - GE - IT - PT)
Leuko64 100 CELL-DYN (ES - FR - GE - IT - NO - PT)

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