Pall Leukotrap® Affinity Plus Prion and Leucocyte Reduction Filter System

Pall Leukotrap Affinity Plus Prion and Leucocyte Reduction Filter System is Not Currently Available for Sale in the U.S. or Canada

Concurrent Prion and Leucocyte Reduction

• Efficacy – Averaging greater than 3 log prion reduction
• Efficiency – Leucocyte reduction meeting current EU and UK guidelines
• Assurance – Maintains therapeutic benefit of red cells
• Easy to Use – Self priming filter for ease of use
• Fast – Rapid filtration 
• High Yield – With unique recovery system

The Pall® Leukotrap Affinity Plus Prion and Leucocyte Reduction Filter System represents a new generation of proprietary filtration technology that concurrently reduces leucocytes and infectious prion to minimize the risk of vCJD through blood transfusion. The filter system captures and reduces target contaminants while allowing the desired components to pass through, even those of equal or larger size.

Pall Leukotrap Affinity Plus Prion and Leucocyte Reduction Filter System

• For post process blood bank filtration of a single unit of non-leucocyte reduced red cells

Prion Reduction Performance

Abnormal prion (PrPSc) is reduced by an average of > 3 log based on enhanced Western Blot methodology as described by Wadsworth et al, 2001¹.

Whole blood units were collected into Top & Top collection systems (CPD/SAGM), held at room temperature for 24 hours and processed into packed red cells. pRBC units were spiked with 10% scrapie infected hamster brain homogenate and filtered using the Pall Leukotrap Affinity Plus Prion and Leucocyte Reduction Filter System. Pre and post filtration samples were collected and processed for Western Blot analysis as described² by Sowemimo-Coker et al. The filtration of spiked red cells resulted in greater than 3 log reduction of abnormal prion protein.

Filtration Performance

Following filtration, residual WBC counts in all filtered units met current EU³ and UK⁴ guidelines.

Whole Blood Volume	Whole Blood Processing Conditions	Day of Filtration	Red Cell Storage
450 mL +/- 10%	Whole blood processed into red cells on day 0 with T/T or T/B method. Red cells stored overnight at 4 °C.	1	CPD/SAGM: 35 days
450 mL +/- 10%	Whole blood held overnight at ambient temperature. Processed into red cells on day 1 with T/T or T/B method.	1	CPD/SAGM: 35 days

Red Cell Storage Studies

Red cell units in anticoagulant/additive solution (CPD/SAGM) were processed using the Pall Leukotrap Affinity Plus Prion and Leucocyte Reduction Filter System and stored to outdate. Performance relating to pH, potassium, sodium, haemolysis and ATP was compliant to guidelines^3,4 and not different to controls. Autologous in-vivo studies have confirmed red cell recoveries well above the FDA and Council of Europe requirements of achieving a mean post transfusion survival of greater than 75% of transfused red cells.

References

1. Wadsworth et al., The Lancet 2001; 358:171-180. 
2. Sowemimo-Coker et al., Vox Sanguinis 2006; 90:265-275.
3. Guide to the Preparation, Use and Quality Assurance of Blood Components. 14th Edition, 2008. Council of Europe Publishing.
4. Guidelines for the Blood Transfusion Services in the UK. 7th Edition, 2005. www.transfusionguidelines.org.uk

The Pall Leukotrap Affinity Plus Prion and Leucocyte Reduction Filter System with Attached Storage Bag and Unique Recovery System

System is sterilized by irradiation and is compatible with sterile connection technology.

Reorder No.	Description	Quantity
PRF2BE	Pall Leukotrap Affinity Plus Prion and Leukocyte Reduction Filter System – with attached red cell storage bag and unique recovery system	20 units per case