Rogers P M, Saldanha J, Allain J P
European Plasma Fractionation Association, Amsterdam, The Netherlands.
Vox Sang. 1997;72(4):199-206. doi: 10.1046/j.1423-0410.1997.7240199.x.
The 3rd annual European Plasma Fractionators Association/National Institut of Biological Standard and Control (EPFA/NIBSC) meeting provided a forum for regulators, blood product and test kit manufacturers and organisations developing standards to present and discuss their latest data. The main conclusions were as follows. There has been substantial progress during the last year in the development of NAT technology specifically for improving the safety of blood products though there is an urgent need for the development of international reference materials. The technology is not yet sufficiently developed to be used as a routine screening test though testing of plasma pools for hepatitis C virus may be achieved within a year. Introduction of testing should not result in the creation of dual standards for plasma derived and cellular products. Once the technology is fully developed it could significantly improve the safety of all blood products, particularly those derived from starting materials with a high incidence of viral markers.
第三届欧洲血浆成分分离协会/国家生物标准与控制研究所(EPFA/NIBSC)年会为监管机构、血液制品和检测试剂盒制造商以及制定标准的组织提供了一个展示和讨论最新数据的平台。主要结论如下。去年,核酸扩增技术(NAT)的开发取得了重大进展,特别是在提高血液制品安全性方面,不过迫切需要开发国际参考物质。该技术尚未充分发展到可作为常规筛查检测手段,尽管对丙型肝炎病毒血浆库的检测可能在一年内实现。引入检测不应导致血浆衍生产品和细胞产品出现双重标准。一旦该技术完全成熟,它可以显著提高所有血液制品的安全性,特别是那些源自病毒标志物高发生率起始原料的制品。