"These results demonstrate robust performance of the Leukotrap Affinity Prion Reduction Filter in removing different strains of prions," said Dr. Coker.
Dr. Coker reviewed results of studies on the safety of the product and details on the measurement of the quality of red cells post prion reduction, including survival, maintaining their integrity and therapeutic value (oxygen carrying properties) and other metabolic activities. On all counts measured, the studies found that the safety of processed red cells was not impaired.
Implementing Prion Reduction into Routine Blood Banking Practice
He also presented results of a new study that identified a surrogate marker to measure prion removal in order to enable quality control in the blood banking process. A surrogate marker is required since concentrations of infectious prion in blood are too low to measure using currently available methods. After review of a number of potential markers, the studies validated that reduction of a plasma protein present in blood and blood components directly correlated with reduction of infectious prion.
Dr. Coker explained, "These findings provide a feasible means for quality control for blood banks in their prion reduction process since the plasma protein can easily be measured with currently available analytical methods."
Studies on the efficacy of the filter's removal of prions under different processing conditions, which can vary by blood center and country in their use of anticoagulants, red cell storage solutions, temperatures, etc., were also reviewed. The studies showed about 99.9 percent prion removal across all conditions.
"The data show that the Leukotrap Affinity Prion Reduction Filter is consistently effective in re
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Contact: Marcia Katz
marcia_katz@pall.com
516-801-9128
Pall Corporation
31-Oct-2005