Evaluation of bacterial inactivation in random donor platelets and single-donor apheresis platelets by the INTERCEPT blood system

Abstract

Background: Blood transfusion of contaminated components is a potential source of sepsis by a wide range of known and unknown pathogens. Collection mechanism and storage conditions of platelets make them vulnerable for bacterial contamination. Several interventions aim to reduce the transfusion of contaminated platelet units; however, data suggest that contaminated platelet transfusion remains very common. Aim: A pathogen inactivation system, “INTERCEPT”, to inactivate bacteria in deliberately contaminated platelet units was implemented and evaluated. Materials and Methods: Five single-donor platelets (SDP) and five random donor platelets (RDP) were prepared after prior consent of donors. Both SDP and RDP units were deliberately contaminated by stable stock ATCC Staphylococcus aureus and Escherichia coli, respectively, with a known concentration of stock culture. Control samples were taken from the infected units and bacterial concentrations were quantified. The units were treated for pathogen inactivation with the INTERCEPT (Cerus Corporation, Concord, CA) Blood system for platelets (Amotosalen/UVA), as per the manufacturer's instructions for use. Post illumination, test samples were analyzed for any bacterial growth. Results: Post-illumination test samples did not result in any bacterial growth. A complete reduction of >6 log10S. aureus in SDP units and >6 log10Escherichia coli in RDP units was achieved. Conclusion: The INTERCEPT system has been shown to be very effective in our study for bacterial inactivation. Implementation of INTERCEPT may be used as a mitigation against any potential bacterial contamination in platelet components.

Keywords

• Amotosalen
• bacterial contamination
• pathogen inactivation
• random donor platelets
• sepsis
• single-donor platelets
• transfusion
• ultraviolet A