Component pathogen inactivation: a critical review

Background and Objectives Pathogen inactivation (PI)-treated plasma and platelets are increasingly becoming the products of choice, where licensed. This review summarizes the clinical evidence available for licensed component PI technologies and red cell PI under development. Materials and Methods Available literature on licensed technologies was reviewed. Results For the plasma and platelets technologies available, evidence for the inactivation of most pathogens is good, except for certain nonenveloped viruses. Clinical trials and haemovigilance programmes suggest the observed loss of potency is of little clinical significance, with some technology-specific exceptions. Concerns over adverse toxicological effects or neoantigen formation have not been confirmed for currently licensed products. Conclusion While platelet PI has been adopted to reduce bacterial contamination, the ability of PI methods to replace testing for emerging bloodborne infections, or as a substitute for selective pathogen testing, gamma-irradiation or even leucodepletion, make adoption of PI for components increasingly attractive.