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Quality Control And Pathogen Inactivation of Platelets

Quality Control And Pathogen Inactivation of Platelets . Ohood Al.Ayyadhi Laboratory Manager Blood Transfusion services Kuwait Central Blood Bank. Pathogen Inactivation. Introduction. Why Pathogen Inactivation. Methods. Kuwait Central Blood Bank Results. Infectious Risks.

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Quality Control And Pathogen Inactivation of Platelets

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  1. Quality Control AndPathogen Inactivation of Platelets • OhoodAl.Ayyadhi • Laboratory Manager • Blood Transfusion services • Kuwait Central Blood Bank

  2. Pathogen Inactivation • Introduction. • Why PathogenInactivation. • Methods. • Kuwait Central Blood Bank Results.

  3. Infectious Risks Transfusion of biological fluids = Viruses, Parasites, Bacteria, Prions, ???

  4. Infectious Risks Test vs Risk Known Unknown

  5. Pathogens of highest concern in the Middle East • Plasmodium falciparum • Leishmania • Babesiamicroti • HIV • HBV • HCV • HTLV • Bacterial Contamination • West Nile virus • SARS • Vaccinia • Chikungunya virus • Dengue • Avian flu virus (H5N1) • Borreliaburgdorferi • Trypanosomacruzi

  6. Kuwait Central Blood Bank

  7. What’s our Scope? • The ONLY Central Blood Bank • 21 Government Hospitals • 20 Private Hospitals • 2 Military Hospitals • Blood product supplier to Allied armies

  8. What’s our Scope? • 69,000 Whole blood donations. • 100% Leukocyte Reduced RBC & Plasma. • 7,794Apheresis Platelets (55,000 units).

  9. What’s our Scope? • AABB Accredited 1989. • CAP Survey 1994. • Accredited by the National Quality Program. • National Reference Laboratory. • Accredited as regional reference center for Arabian countries. • AABB Immunohaematology Reference Lab IRL self assessment 2008.

  10. What’s our Scope? • Training center for post-graduate hematologist. • Training center for pre-graduate medical lab technologist. • Training center for regional countries. • Therapeutic Apharesis Center. • National Antenatal screening program.

  11. Pathogens of highest concern in the Middle East (KCBB) • Bacterial Contamination. • HBV. • HCV. • HIV.

  12. Viral Infectious Risks At KCBB

  13. Infectious Risks at KCBB

  14. Infectious Risks at KCBB

  15. Infectious Risks at KCBB

  16. Infectious Risks at KCBB

  17. Infectious Risks at KCBB

  18. Bacterial Contamination Risksof Platelets At Kuwait Central Blood Bank

  19. Comparison of Residual Risks 1:100 Transmission risk, per unit HIV 1:1000 Bacterial Contamination (platelets) 1:10 000 HBV HCV 1:100 000 Septic Fatalities (platelets) 1:1 000 000 2000 1998 1984 1986 1988 1990 1992 1994 1996 2002 Updated from: Goodnough LT e t al. NEJM 1999;341:126-7

  20. Bacterial Contamination Risks Unit Transfused Risk per Million Units Confirmed Report of Fatality Bacterial Contamination Red Blood Cells 6.0 1.0 Platelet pheresis units 32 7.1 TOTAL, all units 7.4 1.1 Perez P et al. Transfusion 1999;39:2S.

  21. Bacterial Contamination Risks Unit Transfused Risk per Million Units Confirmed Report of Fatality Bacterial Contamination Red Blood Cells 6.0 1.0 Platelet pheresisunits 32 7.1 TOTAL, all units 7.4 1.1 1/140,800 Perez P et al. Transfusion 1999;39:2S.

  22. Bacterial Contamination Risks Unit Transfused Risk per Million Units Confirmed Report of Fatality Bacterial Contamination Red Blood Cells 6.0 1.0 Platelet pheresisunits 32 7.1 TOTAL, all units 7.4 1.1 1/140,800 1/31,000 Perez P et al. Transfusion 1999;39:2S.

  23. Frequency of Contamination Based on Johns Hopkins’ Data PltConcSDP Post-transfusion sepsis 402/million 75/million Fatalities 62/million 14/million Ness PM et al. Transfusion 2001;41:857-61. Recalculation: LJ Dumont.

  24. Frequency of Contamination Based on Johns Hopkins’ Data PltConcSDP Post-transfusion sepsis 402/million 75/million Fatalities 62/million 14/million Compare: HIV 0.33/million HCV 1/million Ness PM et al. Transfusion 2001;41:857-61. Recalculation: LJ Dumont.

  25. Bacterial ContaminationAABB STD 5.1.5.1 The blood bank or transfusion services shall have methods to limit and detect bacterial contamination in all platelet components.

  26. History of testing in KCBB

  27. Bacterial Risk at KCBB • 6,800 ApheresisPlatelets (~ 40,000 units). • 0.5 – 1 confirmed cases of sepsis per year.

  28. Bacterial Detection • Scansystem • March 05 – May 07 • 26,000 units • eBDS Pall • June 07 – May 08 • 14,000 units • 10% of collection tested by culture as QC

  29. Bacterial Detection

  30. Mitigation • Delay of component release (2 days) • Complexity of procedures • Results: • False positives (0.2 %) • False negatives (0.05%) • Safety?: • Did not prevent all septic transfusion reactions • Did change the risks of bacterial contamination.

  31. Pathogen InactivationWHY ?

  32. Why is Pathogen InactivationImportant? • Reduced risk of bacterially contaminated platelet transfusion • Further closing of window period for screened viruses • Added protection against untested pathogens (e.g. Chagas) • Pro-active protection against emerging pathogens (e.g. Chikungunya, West Nile) • Possible reduction in adverse transfusion events • Potential to revisit donor deferral strategies and enlarge donor pool • Public expectation of ‘ZERO risk’

  33. Pathogen InactivationSystems

  34. Platelet Pathogen Inactivation Systems • Intercept • Amotosalen + UV

  35. Platelet Pathogen Inactivation Systems • Intercept • Mirasol • Riboflavin + UV

  36. Platelet Pathogen Inactivation Systems • Intercept • Mirasol • Theraflex UV

  37. InterceptBlood System for Platelets

  38. Mechanism of Action UVA Illumination Amotosalen DNA or RNAof pathogen Crosslinking Intercalation

  39. Amatosalen Cross links Both Single and Double Stranded Nucleic Acids Helical Regions Single-strandedDNA or RNA Double-strandedDNA or RNA

  40. INTERCEPT Blood System for Platelets Integrated Processing Set 4 CAD 5 Storage 1 Collection 2 Amotosalen 3 Illumination UVA Illumination Device

  41. Mirasol® Pathogen Reduction Technology System

  42. Mirasol PRT System Overview • The MirasolPRT System uses riboflavin (vitamin B2)and UV light to inactivate pathogens, altering their nucleic acids so they cannot replicate.

  43. Mechanism of Action • UV light + riboflavin: irreversible inactivation • Riboflavin molecules form complexes with nucleic acids • UV light from the Mirasol Illuminator activates the riboflavin molecule in the complex • Photoactivated riboflavin induces a chemical alteration to the functional groups (such as guanine bases) of nucleic acids making pathogens unable to replicate

  44. MirasolPRT System Concept • Reduction of viruses, bacteria, parasites • Inactivation of residual white cell + + Riboflavin(Vitamin B2) solution Platelet or Plasma product UV Light

  45. Theraflex UVSystem

  46. Theraflex

  47. Theraflex • Methylen Blue and UV illumination device used as a technique for Pathogen Reduction

  48. KCBBClinical Experience withPlatelet PI

  49. Pathogen Inactivation (INTERCEPT) Implementation • Training, March 2008 • Validation, May 2008 • 100 % Pathogen Inactivation of Platelets replaced 1st May 2008 • AABB inspection 15th May 2008

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