Background: Yersinia enterocolitica, Pseudomonas fluorescens, and P. putida are responsible for a significant amount of the bacterial sepsis cases attributed to RBC transfusions. INACTINE is a pathogen-reduction process for RBCs, which consists of incubation of RBCs with PEN110 (proprietary compound) followed by automated washing of the RBCs. INACTINE is an electrophilic agent, which inactivates a wide range of viruses and WBCs by disruption of nucleic acid replication. The present study investigated the effect of the PEN110 process on Y. enterocolitica, P. fluorescens, and P. putida.
Study design and methods: Identical units of reduced CPD/ADSOL additive solution (AS-1) or CP2D/Nutricel additive solution (AS-3) RBCs were inoculated with 10 to 100 CFU per mL of either Y. enterocolitica, P. fluorescens, or P. putida. The control units were put on storage immediately after the bacterial spike. The test units were subjected to the PEN110 process and then stored. Sham control units were processed the same way as test units without addition of PEN110. Bacterial titer in all units was monitored during the 6-week storage period.
Results: No bacteria were detected in any of the RBC units (n = 9 for each microorganism) prepared using the PEN110 process throughout 6 weeks of storage. Substantial bacterial growth occurred in all control and in a majority of sham control units (11 out of 15 experiments). The bacterial inactivation by the INACTINE process was found to be equally effective in CPD/AS-1 and CP2D/AS-3 RBC units.
Conclusion: The INACTINE process effectively prevented the outgrowth of Y. enterocolitica, P. fluorescens, and P. putida deliberately inoculated into WBC-reduced CPD/AS-1 and CP2D/AS-3 RBCs. The results demonstrated the crucial bactericidal role of PEN110 in the INACTINE process.