Background: The Mirasol system for whole blood (WB) is a non-toxic, non-mutagenic pathogen reduction technology (PRT) that treats WB units with riboflavin (vitamin B2) and ultraviolet (UV) light to alter nucleic acids, thereby reducing pathogen infectivity and inactivating white blood cells. This study evaluates the quality of red blood cells (RBCs) derived from WB treated with the Mirasol system. Study Design and Methods: Paired units of WB were collected from 61 healthy donors. One unit per donor was treated with riboflavin and UV light and the other was used as an untreated control. RBCs were processed from the WB units and stored in AS-3 at 1–6°C for 21 days and sampled for in vitro analyses of RBC quality parameters. Results: Several statistically significant differences were observed between test and control units, but values were overall within normal clinical ranges. After leukoreduction, the residual leukocyte count and RBC recovery met FDA requirements. The RBC units derived from treated WB maintained haemolysis below 1% through 21 days of storage. Conclusion: RBCs derived from WB treated with the Mirasol system meet accepted FDA guidelines for RBC quality through 21 days of storage at 1–6°C.

中文翻译：

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来自经核黄素和紫外线处理的全血的红细胞在 21 天的储存过程中仍能保持足够的细胞质量

背景：全血 (WB) Mirasol 系统是一种无毒、非诱变病原体减少技术 (PRT)，它用核黄素（维生素 B2）和紫外线 (UV) 处理 WB 单位以改变核酸，从而减少病原体传染性和灭活白细胞。本研究评估了经 Mirasol 系统处理的 WB 中提取的红细胞 (RBC) 的质量。研究设计和方法：从 61 名健康捐献者中收集配对的 WB 单位。每个供体的一个单位用核黄素和紫外线处理，另一个用作未处理的对照。从 WB 单元中处理红细胞，并在 1–6°C 的 AS-3 中保存 21 天，并取样用于红细胞质量参数的体外分析。结果：在测试单元和对照单元之间观察到一些统计上显着的差异，但值总体在正常临床范围内。去白细胞后，残留白细胞计数和红细胞回收率均满足FDA要求。来自处理过的 WB 的红细胞单位在储存 21 天时保持溶血低于 1%。结论：来自经 Mirasol 系统处理的 WB 的红细胞在 1–6°C 下储存 21 天后符合 FDA 公认的红细胞质量指南。