Protein quality in Mirasol pathogen reduction technology-treated, apheresis-derived fresh-frozen plasma

BACKGROUND: The Mirasol pathogen reduction technology (PRT) system for plasma is based on a riboflavin (vitamin B-2) and ultraviolet (UV) light treatment process resulting in pathogen inactivation due to irreversible photo-oxidative damage of nucleic acids. The purpose of this study was to evaluate the in vitro protein quality of apheresis-derived plasma treated with riboflavin and UV light in comparison with untreated fresh-frozen plasma (FFP). STUDY DESIGN AND METHODS: Twenty apheresis plasma samples (270 +/- 10 mL) were combined with 35 +/- 5 mL of riboflavin solution (500 mu M), yielding a mean 60 mu M final riboflavin concentration, and then exposed to UV light (6.24 J/mL). Riboflavin and UV light-treated plasma was then flash frozen, within 8 hours of collection, generating treated FFP. Treated FFP was thawed and analyzed using standard coagulation assays, and the percent retention of protein activity was reported, relative to untreated, paired controls. RESULTS: Plasma proteins demonstrated different sensitivities to riboflavin and UV treatment. The amount of total protein remained unchanged. After treatment, fibrinogen (antigen) showed 99% retention; Factor (F)XII, FXIII, ADAMTS-13, and von Willebrand factor (ristocetin cofactor) 96% to 100%. Fibrinogen retained 77% activity, FII 80%, FVIIIc 75%, and FV 73% after treatment. Antithrombin, protein S, plasminogen, and alpha(2)-antiplasmin retained between 91 and 100% activity. CONCLUSION: The results from this study demonstrate that coagulant and anticoagulant proteins in riboflavin and UV light-treated (PRT) apheresis plasma are well preserved.