Ettinger Anna, Miklauz Meghan M, Hendrix Brianna K, Bihm David J, Maldonado-Codina Gabriela, Goodrich Raymond P
CaridianBCT Biotechnologies, LLC, Lakewood, CO 80215, USA.
Transfus Apher Sci. 2012 Feb;46(1):15-8. doi: 10.1016/j.transci.2011.10.015. Epub 2011 Nov 23.
The Mirasol® Pathogen Reduction Technology (PRT) System for plasma combines riboflavin (vitamin B(2)) and UV light energy to reduce pathogens in plasma products. This study evaluated protein quality of apheresis derived plasma products treated with riboflavin and UV light and stored at -18°C for up to 1 year. Comparisons were made to paired, untreated controls after 6 months and 1 year of storage.
This study evaluated the in vitro protein quality of apheresis derived plasma products processed between 8 and 8.5 h from collection and stored at -18°C for 6 months and 1 year. Plasma (205±5 mL) was combined with 35±5 mL of 500 μM riboflavin, and exposed to UV light (6.24 J/mL). A total of 14 plasma units were used for this study. Plasma units were analyzed using standard coagulation assays immediately following treatment, and after 6 months and 1 year of storage at -18°C.
Fibrinogen, Total protein, Factors II, VIII, IX, X and XII were modestly affected by storage for 1 year at -18°C. The average percent protein retention in treated plasma samples after 1 year of storage in comparison to controls held under similar conditions were: Total Protein, 103%, Factor II, 88%, Factors VII and XI, 62%, Factor V 60%, Factor VIII and IX, 77%, Fibrinogen, 75%, Factor X, 85% and Factor XII, 82%.
Results after 6 months (double the EU guidelines recommended storage time) and 1 year (four times longer than the EU guidelines recommended storage time) of storage at -18°C demonstrated that all proteins were well preserved. Values observed for treated products stored under these conditions are within the same range as those reported for other pathogen inactivated plasma products.
用于血浆的Mirasol®病原体灭活技术（PRT）系统结合核黄素（维生素B2）和紫外线能量以减少血浆制品中的病原体。本研究评估了经核黄素和紫外线处理并在-18°C储存长达1年的单采血浆制品的蛋白质质量。在储存6个月和1年后，与配对的未处理对照进行比较。
本研究评估了采集后8至8.5小时内处理并在-18°C储存6个月和1年的单采血浆制品的体外蛋白质质量。将血浆（205±5 mL）与35±5 mL的500 μM核黄素混合，并暴露于紫外线（6.24 J/mL）。本研究共使用了14个血浆单位。在处理后、在-18°C储存6个月和1年后，立即使用标准凝血试验分析血浆单位。
纤维蛋白原、总蛋白、凝血因子II、VIII、IX、X和XII在-18°C储存1年受到适度影响。与在类似条件下保存的对照相比，处理后的血浆样品储存1年后的平均蛋白质保留百分比为：总蛋白103%，凝血因子II 88%，凝血因子VII和XI 62%，凝血因子V 60%，凝血因子VIII和IX 77%，纤维蛋白原75%，凝血因子X 85%，凝血因子XII 82%。
在-18°C储存6个月（欧盟指南推荐储存时间的两倍）和1年（比欧盟指南推荐储存时间长四倍）后的结果表明，所有蛋白质均保存良好。在这些条件下储存的处理后产品观察到的值与其他病原体灭活血浆制品报道的值在同一范围内。
