Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026)

Atreya, Chintamani; Glynn, Simone; Busch, Michael; Kleinman, Steve; Snyder, Edward; Rutter, Sara; AuBuchon, James; Flegel, Willy; Reeve, David; Devine, Dana; Cohn, Claudia; Custer, Brian; Goodrich, Raymond; Benjamin, Richard J.; Razatos, Anna; Cancelas, Jose; Wagner, Stephen; Maclean, Michelle; Gelderman, Monique; Cap, Andrew; Ness, Paul

Speaker's summary: Blood donor screening began in the 1940s with testing for syphilis, followed in the early 1970s by testing for hepatitis B surface antigen. The discovery of human immunodeficiency virus (HIV), human T-lymphotropic viruses, and hepatitis C virus (HCV) and introduction of progressively more sensitive serological assays targeting virus-specific antibodies and antigens for these "classic" transfusion-transmitted infections (TTIs) in the 1980s and 1990s was effective in interdicting the majority of infectious blood donations. 1 Implementation of NAT screening for HIV, HCV, and hepatitis B virus (HBV) further reduced the residual risk of infectious window period donations, such that per-unit risks are less than one in 1,000,000 in the United States (Fig. 1 ). [2] [3] [4] We now recognize that in addition to classic TTIs that establish chronic infection, agents that cause acute transient infections may also be TTI at significant rates if there are large epidemics or recurrent seasonal transmission. [5] [6] [7] Salient examples of EIDs where interventions were implemented in the United States include nationwide screening of donors for Trypanosoma cruzi using a one-time antibody testing strategy, 8 NAT testing for West Nile virus (WNV) 9, 10 and Zika virus (ZIKV), 11, 12 and testing for Babesia microti in endemic regions. 13, 14 Testing for bacterial contamination of PLT components was instituted in the 2000s to prevent septic transfusion reactions. 15 Donor deferrals were also implemented to reduce other risks including variant Creutzfeldt-Jakob disease and several other agents. 16 Fig. 1 lists the EIDs for which interventions were implemented over the past two decades.