Cerus Corporation, Concord, CA, USA Concord, California, United States
Background/Case Studies: Amotosalen and UVA light were used to inactivate pathogens and leukocytes in platelet concentrates. Platelets are typically stored up to 5 days prior to transfusion, but in combination with PR, platelets can be stored up to 7 days in Canada and other geographies where BCPC are manufactured.
Study
Design/Methods: To evaluate whether the inactivation of bacterial strains of clinical importance is complete at Day 7 post-treatment, BCPC units were prepared and suspended in 47% plasma/53% SSP+ and pooled to a volume of 420 mL with a platelet dose of 7.1 to 8.0 × 1011. A minimum of four replicates were performed for each bacterial strain. The BCPC units were inoculated with bacteria and treated with amotosalen/UVA. Samples were taken pre- and post-UVA illumination, post-CAD, Day 3, Day 5 and Day 7 post-treatment and were analyzed for bacterial titer by plating on appropriate media (100 µL – 5 mL/plate) and incubated for at least 24 hours.
Results/Findings: Treatment of inoculated BCPC units with amotosalen/UVA resulted in bacterial inactivation out to Day 7 of post-treatment storage (Table 1).
Conclusions: Amotosalen and UVA light were used to inactivate clinical bacterial strains in BCPC. While the limit of inactivation may differ depending on the bacterial strain, for each strain tested, no viable bacteria were detected at the end of Day 7 post-treatment.
