The Mirasol PRT System (Gambro BCT, Lakewood, CO) for platelets and plasma uses riboflavin and UV light to reduce pathogens and inactivate white blood cells in donated blood products. An extensive toxicology program, developed in accordance with International Organisation for Standardisation (ISO) 10993 guidelines, was performed for the Mirasol PRT system. Test and control articles for most of the reported studies were treated (test) or untreated (control) blood products. For some studies, pure lumichrome (the major photoproduct of riboflavin) or photolyzed riboflavin solution was used. Systemic toxicity was evaluated with in vivo animal studies in the acute and subchronic settings. Developmental toxicity was evaluated with an in vivo animal study. Genotoxicity and neoantigenicity were evaluated with in vitro and in vivo tests. Hemocompatibility and cytotoxicity were assessed with standard, in vitro assays. The pharmacokinteics, excretion, and tissue distribution of (14)C-riboflavin and its photoproducts was evaluated with an in vivo animal study. The possible presence of leachable or extractable compounds (from the disposable set) was evaluated with novel assays for measuring these compounds in blood. No treatment-related toxicity was observed in any of the studies.

中文翻译：

---

一种基于核黄素的新型技术对病原体减少和白细胞灭活的毒性测试。

用于血小板和血浆的Mirasol PRT系统（Gambro BCT，Lakewood，CO）使用核黄素和紫外线来减少病原体并使失活的血液制品中的白细胞失活。根据国际标准化组织（ISO）10993指南开发的广泛的毒理学程序，用于Mirasol PRT系统。对于大多数报告的研究，测试和对照物品均为经过处理（测试）或未经处理（对照）的血液制品。为了进行某些研究，使用了纯发光色素（核黄素的主要光产物）或光解核黄素溶液。通过在急性和亚慢性环境下的体内动物研究评估了全身毒性。通过体内动物研究评估了发育毒性。通过体外和体内试验评估了基因毒性和新抗原性。用标准的体外测定法评估血液相容性和细胞毒性。（14）C-核黄素及其光产物的药代动力学，排泄和组织分布已通过体内动物研究进行了评估。用可测定血液中这些化合物的新颖测定法评估了可浸出或可萃取化合物（来自一次性使用品）的可能存在。在任何研究中均未观察到与治疗相关的毒性。