Evaluation of the effectiveness of a pathogen inactivation technology against clinically relevant transfusion-transmitted bacterial strains
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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. STUDY DESIGN AND 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. CONCLUSION: 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.
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