Author: 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
Title: Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026) Document date: 2019_5_29
ID: 0m2ganys_61
Snippet: The completed studies demonstrated the safety and efficacy of INTERCEPT RBCs while in vitro analyses demonstrated robust PI. Further US clinical studies in cardiac surgery (ReCePI) and in the general hospital population (RedeS) are under way (see ClinicalTrials.gov). The availability of PRTs for RBCs, PLTs, and plasma would increase patient safety and revolutionize the current reactive, incremental testing approach to infectious disease threats. .....
Document: The completed studies demonstrated the safety and efficacy of INTERCEPT RBCs while in vitro analyses demonstrated robust PI. Further US clinical studies in cardiac surgery (ReCePI) and in the general hospital population (RedeS) are under way (see ClinicalTrials.gov). The availability of PRTs for RBCs, PLTs, and plasma would increase patient safety and revolutionize the current reactive, incremental testing approach to infectious disease threats. It may also allow a reassessment of the need for current donor deferral and testing requirements.
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