Malvaux Nicolas, Schuhmacher Anne, Defraigne Fanette, Jacob Remy, Bah Aicha, Cardoso Marcia
Luxembourg Red Cross, Boulevard Joseph II 42, L-1840, Luxembourg.
Terumo BCT Europe, Ikaroslaan 41, 1930 Zaventem, Belgium.
Transfus Apher Sci. 2021 Oct;60(5):103195. doi: 10.1016/j.transci.2021.103195. Epub 2021 Jun 15.
In 2014-2015, the Luxembourg Red Cross (LRC) implemented a fully automated system (FAS) able to process 4 whole blood units simultaneously, and a pathogen reduction technology (PRT) based on riboflavin and ultraviolet light to improve safety of platelet concentrates (PCs). In this observational study, the impact of both technologies to enable this centralised blood transfusion centre to provide safe and timely blood components supply for the whole country was analysed. Standard quality control parameters for blood components, productivity and safety were compared from data collected with the conventional semi- automated buffy coat method and with FAS/PRT. The FAS decreased processing time when compared with the buffy coat method and facilitated the daily routine at the LRC. Red blood cell concentrates, plasma units and PCs prepared with both methods were conform to the European Directorate for the Quality of Medicines & HealthCare specifications. PCs prepared by FAS showed high yields, with decreased variability when the device-related software (T-Pool Select) was used. PRT had minimal impact on platelet yields and product quality and induced no increase in transfusion reaction notifications. The FAS and PRT transformed the daily routine of blood component manufacture by allowing increased productivity and efficiency, notwithstanding resource containment and without impacting quality, yet promoting safety.
2014 - 2015年,卢森堡红十字会(LRC)实施了一个能够同时处理4个全血单位的全自动系统(FAS),以及一种基于核黄素和紫外线的病原体灭活技术(PRT),以提高血小板浓缩物(PC)的安全性。在这项观察性研究中,分析了这两种技术对使这个集中输血中心能够为全国提供安全、及时的血液成分供应的影响。根据使用传统半自动白膜层法以及FAS/PRT收集的数据,对血液成分的标准质量控制参数、生产率和安全性进行了比较。与白膜层法相比,FAS缩短了处理时间,并便利了LRC的日常工作。用这两种方法制备的红细胞浓缩物、血浆单位和PC均符合欧洲药品和医疗保健质量管理局的规范。当使用与设备相关的软件(T-Pool Select)时,通过FAS制备的PC产量高,变异性降低。PRT对血小板产量和产品质量的影响最小,且未导致输血反应报告增加。FAS和PRT通过提高生产率和效率改变了血液成分制造的日常工作,尽管资源有限,但不影响质量,同时提高了安全性。