Pathogen Reduction in Platelets: A Review of the Proposed Draft Guidance

Abstract

In an effort to reduce the incidence of transfusion-transmitted infections (TTI) and septic transfusion reactions (STR) from bacterially-contaminated platelet products, the Center for Biologics Evaluation and Research (CBER) department of the Food and Drug Administration (FDA) recently published draft guidance in March of 2016. Entitled, “Bacterial Risk Control Strategies for Blood Collections Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” the new guidance recommends either the use of rapid bacterial testing at point-of-issue on days four or five of stored platelets or the use of pathogen reduction technology (PRT) at the time of platelet collection. A literature review demonstrates that both methodologies effectively reduce the incidence of TTI and STR without compromising the efficacy of the platelet product. However, the use of PRT has further-reaching implications. Utilizing amotosalen in the presence of ultraviolet (UV) light, PRT intercalates with nucleic acids. Not only does this render bacteria inactive, it also inactivates viruses and protozoa. This effectively eliminates the need for some viral testing, and reduces the risk of TTIs due to new and emerging pathogens. The use of PRT, therefore, proves to be the superior option for both transfusion services and blood collection centers, with implications for future use with additional blood products such as whole blood. ABBREVIATIONS:TTI - transfusion-transmitted infections, STR - septic transfusion reactions, CBER - Center for Biologics Evaluation and Research, FDA - Food and Drug Administration, AABB - organization formerly, the American Association of Blood Banks, TS - transfusion services, PRT - Pathogen-Reduction Technology, PGD - Pan Genera Detection, CMV - cytomegalovirus