Background/Case Studies: The INTERCEPT® Blood Systems for platelets and plasma utilize amotosalen and UVA light to efficiently inactivate a wide range of pathogens and leukocytes in platelet concentrates (PC) and plasma. The World Health Organization (WHO) Expert Committee on Biological Standardization (ECBS) in association with the Paul-Ehrlich-Institut (PEI) approved an extended panel of bacterial strains to evaluate methods for improving the microbial safety of blood components in 2015 (Spindler-Raffel et al, 2015).
Study
Design/Methods: Apheresis PC collected in 100% plasma or 65% PAS-3/35% plasma (65%/35%) were pooled into individual units of 420 mL with platelet doses of 4.0 to 5.0 × 1011 and 4.0 to 7.9 × 1011 respectively. Human plasma donations were collected and pooled to yield individual units of ~650 mL. Four replicates per platelet matrix were performed for each PEI strain of transfusion-relevant bacteria, including K. pneumoniae and S. aureus in plasma, with each replicate consisting of one unit spiked with a single PEI strain. The contaminated PC and plasma units were then treated with amotosalen and UVA light in the INTERCEPT Blood System for platelets and plasma, respectively. Samples were taken pre- and post-UVA treatment (5 mL and 50 mL, respectively) and were analyzed for bacterial titer by plating on appropriate media (100µL–10mL/plate).
Results/Findings: Platelet and plasma units contaminated with PEI bacterial strains (Table 1) were treated with amotosalen and UVA in the INTERCEPT Blood System for platelets and plasma, respectively. Robust bacterial inactivation was observed post-treatment (Table 1). Conclusions: The INTERCEPT Blood System for Plasma consistently inactivated high titers of K. pneumoniae and S. aureus. The INTERCEPT Blood System for Platelets efficiently inactivated K. pneumoniae, S. aureus, E. coli, S. epidermidis, S. marcescens and S. pyogenes. The data demonstrate that that the INTERCEPT Blood System for platelets and plasma robustly inactivate the tested WHO standardized bacteria strains associated with TTBI.
Importance of research: The World Health organization (WHO) Expert Committee on Biological Standardization (ECBS) in association with the Paul-Ehrlich-Institute (PEI) approved an extended panel of bacterial strains to evaluate methods for improving the microbial safety of blood component (Spindler-Raffel et al, 2015). This study evaluated for the first time the inactivation of WHO reference (PEI) bacterial strains in platelet and plasma components using Amotosalen and UVA light.
