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

Assuming that therapeutic product efficacy is maintained and cost issues can be addressed, the goal is to have all blood components (RBCs, PLTs, plasma) or WB (before component separation) treated by PI-this could then allow for the relaxation of redundant donor laboratory screening, modification of donor questioning and/or deferral, simplified handling of postdonation information, and elimination of the need for irradiation of cellular components to prevent transfusionassociated graft-versus-host disease (TA-GVHD). Potential blood screening changes include eliminating syphilis, T. cruzi, cytomegalovirus (CMV), and Babesia testing; modifying the menu of HBV tests; eliminating off-season WNV and ZIKV testing; and eliminating ID-NAT. A fully PI-treated blood supply would shape the response to threats from new enzyme immunoassays in that there would be less pressure to develop laboratory screening assays.