Irsch Johannes, Lin Lily
Cerus Europe BV, Amersfoort, the Netherlands.
Transfus Med Hemother. 2011;38(1):19-31. doi: 10.1159/000323937. Epub 2011 Jan 27.
The transmission of pathogens via blood transfusion is still a major threat. Expert conferences established the need for a pro-active approach and concluded that the introduction of a pathogen inactivation/reduction technology requires a thorough safety profile, a comprehensive pre-clinical and clinical development and an ongoing hemovigilance program. MATERIAL AND METHODS: The INTERCEPT Blood System utilizes amotosalen and UVA light and enables for the treatment of platelets and plasma in the same device. Preclinical studies of pathogen inactivation and toxicology and a thorough program of clinical studies have been conducted and an active he-movigilance-program established. RESULTS: INTERCEPT shows robust efficacy of inactivation for viruses, bacteria (including spirochetes), protozoa and leukocytes as well as large safety margins. Furthermore, it integrates well into routine blood center operations. The clinical study program demonstrates the successful use for very diverse patient groups. The hemovigilance program shows safety and tolerability in routine use. Approximately 700,000 INTERCEPT-treated products have been transfused worldwide. The system is in clinical use since class III CE-mark registration in 2002. The safety and efficacy has been shown in routine use and during an epidemic. CONCLUSION: The INTERCEPT Blood System for platelets and plasma offers enhanced safety for the patient and protection against transfusion-transmitted infections.
通过输血传播病原体仍然是一个重大威胁。专家会议确定需要采取积极主动的方法，并得出结论，引入病原体灭活/减少技术需要全面的安全性概况、全面的临床前和临床开发以及持续的血液监测计划。材料与方法：INTERCEPT血液系统利用氨甲环酸和紫外线A光，能够在同一设备中处理血小板和血浆。已经进行了病原体灭活和毒理学的临床前研究以及全面的临床研究计划，并建立了积极的血液监测计划。结果：INTERCEPT对病毒、细菌（包括螺旋体）、原生动物和白细胞显示出强大的灭活效果以及较大的安全边际。此外，它很好地融入了血液中心的常规操作。临床研究计划证明其在非常多样化的患者群体中成功使用。血液监测计划显示了其在常规使用中的安全性和耐受性。全球已输注了约70万份经INTERCEPT处理的产品。自2002年获得III类CE标志注册以来，该系统一直在临床使用。其安全性和有效性已在常规使用和疫情期间得到证明。结论：用于血小板和血浆的INTERCEPT血液系统为患者提供了更高的安全性，并预防输血传播感染。
