title: Evaluation of the effectiveness of a pathogen inactivation technology against clinically relevant transfusion-transmitted bacterial strains.
abstract: BACKGROUND
  To increase blood safety, various procedures are currently implemented, including donor selection, optimized donor arm disinfection, and diversion. In addition, pathogen inactivation (PI) techniques can be used for platelets (PLTs) and plasma concentrates.
  
  
  METHODS
  This study investigated the clinical efficacy of an inactivation technique for different blood components at two time points (12 and 35.5 hr). Eight transfusion-relevant bacterial strains were spiked at two different concentrations (100 and 1000 colony-forming units [CFUs]/bag) into whole blood (WB), apheresis PLTs (APs), and buffy coat (BC)-derived minipool PLTs.
  
  
  RESULTS
  The bacterial concentrations were higher than 10(6) CFUs/mL within 24 hours after spiking depending on the particular bacterial strain. PI was absolute for all of the APs performed 12 hours after inoculation, but the bacterial strains of Klebsiella pneumoniae and Bacillus cereus were not completely inactivated in WB or BC PLTs, performed 35.5 and 12 hours after inoculation, respectively.
  
  
  CONCLUSIONS
  The INTERCEPT PI system was not 100% effective for high concentrations of certain K. pneumoniae strains or spore-forming B. cereus. A critical observation was that the period between blood donation and inactivation needs to be minimal to enable efficient PI. In the case where PI cannot be performed immediately after preparation, a combination of a PI technology after the production of blood components with a rapid bacterial screen test on Day 4 or 5 after donation may offer a solution to further prevent the risk of bacterial transmission by transfusion.
authors.affiliation: DRK Blutspendedienst Baden-Württemberg-Hessen gGmbH, Institute of Transfusion Medicine and Immunohematology, Goethe University Frankfurt am Main, and.
authors.forename: Michael
authors.initials: M
authors.lastname: Schmidt
authors.affiliation: DRK Blutspendedienst Baden-Württemberg-Hessen gGmbH, Institute of Transfusion Medicine and Immunohematology, Goethe University Frankfurt am Main, and.
authors.forename: Michael K
authors.initials: MK
authors.lastname: Hourfar
authors.affiliation: DRK Blutspendedienst Baden-Württemberg-Hessen gGmbH, Institute of Transfusion Medicine and Immunohematology, Goethe University Frankfurt am Main, and.
authors.forename: Walid
authors.initials: W
authors.lastname: Sireis
authors.affiliation: DRK Blutspendedienst Baden-Württemberg-Hessen gGmbH, Institute of Transfusion Medicine and Immunohematology, Goethe University Frankfurt am Main, and.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Pfeiffer
authors.affiliation: Institute for Medical Microbiology and Infection Control, Hospital of Goethe-University, Frankfurt am Main, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Göttig
authors.affiliation: Institute for Medical Microbiology and Infection Control, Hospital of Goethe-University, Frankfurt am Main, Germany.
authors.forename: Volkhard A J
authors.initials: VA
authors.lastname: Kempf
authors.affiliation: National Bacteriology Laboratory, NHS Blood and Transplant, Colindale, London, UK.
authors.forename: Carl P
authors.initials: CP
authors.lastname: McDonald
authors.affiliation: DRK Blutspendedienst Baden-Württemberg-Hessen gGmbH, Institute of Transfusion Medicine and Immunohematology, Goethe University Frankfurt am Main, and.
authors.forename: Erhard
authors.initials: E
authors.lastname: Seifried
mesh_terms: D001409:Bacillus cereus; D001792:Blood Platelets / Q000382:microbiology; D058731:Blood Safety / Q000379:methods*; D004203:Disinfection / Q000379:methods*; D046148:Donor Selection / Q000379:methods*; D006801:Humans; D007711:Klebsiella pneumoniae; D050296:Microbial Viability; D010949:Plasma / Q000382:microbiology