(P-TS-9) Amotosalen/UVA Treatment of Plasma Components to Inactivate WHO Reference Bacterial Strains Using the INTERCEPT Blood System

Background/Case Studies: The INTERCEPT® Blood System for Plasma utilizes amotosalen and UVA light to inactivate a wide range of pathogens in plasma and is available both in Europe and the US. The World Health Organization (WHO) Expert Committee on Biological Standardization (ECBS) in association with the Paul-Ehrlich-Institut (PEI) approved an extended panel of platelet transfusion-relevant bacterial reference strains to evaluate methods for improving the microbial safety of blood components (Spindler-Raffel et al, 2017).

Study

Design/Methods:

Human plasma donations were collected and pooled to yield individual units of ~650 mL. A minimum of three replicates were performed for each PEI strain of transfusion-relevant bacteria, including S. aureus, P. fluorescens, E. cloacae, B. thuringiensis, K. pneumoniae, E. coli and S. marcescens, with each replicate consisting of one unit spiked with a single PEI strain. The contaminated plasma units were then treated with amotosalen and UVA light. 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:

Treatment of the contaminated plasma units with amotosalen and UVA resulted in robust bacterial inactivation (Table 1).

Conclusions:

The INTERCEPT Blood System for Plasma consistently inactivated high titers of S. aureus and P. fluorescens, E. cloacae, B. thuringiensis, K. pneumoniae, E. coli and S. marcescens. The data demonstrate robust inactivation of the WHO standardized platelet transfusion-relevant bacterial reference strains.  

References

Spindler-Raffel et al,. 2017 Enlargement of the WHO international repository for platelet transfusion-relevant bacteria reference strains. Vox Sang, 112: 713-722.