Istituto Superiore di sanità, Viale Regina Elena 299, 00161 Rome, Italy.
European Directorate for the Quality of Medicines & HealthCare, Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France.
Pharmeur Bio Sci Notes. 2023;2023:15-41.
The European Pharmacopoeia (Ph. Eur.) monographs and require that plasma pools be tested for hepatitis C virus (HCV) RNA presence by nucleic acid amplification techniques (NAT) using a positive control at 100 IU/mL. HCV RNA for NAT testing BRP batch 1 was established in 1999 to this end. Due to dwindling stocks, the European Directorate for the Quality of Medicines & HealthCare (EDQM) organised a collaborative study to establish a replacement batch. The candidate material was produced as a lyophilised preparation of human plasma containing HCV genotype IA and calibrated against the 6th WHO International Standard for HCV RNA for NAT. Quantitative and qualitative HCV NAT assays based on real-time quantitative PCR techniques were used. Both types of assays were assessed separately. However, since no significant difference was observed between them, all results were pooled for the final potency assignment. Calculations based on Ct values were less variable than those based on end-point dilutions; they were thus used in the final combination. The combined overall mean potency was 959 IU/vial. An accelerated degradation study showed that the stability of the candidate material was satisfactory at the recommended long-term storage temperature, i.e. -20°C. The candidate BRP was established as Ph. Eur. HCV RNA for NAT testing BRP batch 2 by the Ph. Eur. Commission, with an assigned potency of 960 IU/vial. It will be available from the EDQM under catalogue number H0215000.
《欧洲药典》（Ph. Eur.）专论要求通过核酸扩增技术（NAT）用 100IU/mL 的阳性对照测试丙型肝炎病毒（HCV）RNA 的存在。BRP 批 1 用于 NAT 测试的 HCV RNA 是为此目的于 1999 年建立的。由于库存减少，欧洲药品质量管理局（EDQM）组织了一项合作研究，以建立替代批次。候选材料作为含有 HCV 基因型 IA 的冻干人血浆制备，并针对第 6 次世界卫生组织 HCV RNA 用于 NAT 的国际标准进行校准。基于实时定量 PCR 技术的定量和定性 HCV NAT 检测用于评估。这两种类型的检测分别进行了评估。然而，由于它们之间没有观察到显著差异，因此所有结果都被汇总用于最终效力赋值。基于 Ct 值的计算比基于终点稀释的计算更具可变性；因此，它们在最终组合中被使用。组合的总体平均效力为 959IU/瓶。加速降解研究表明，候选材料在建议的长期储存温度（即-20°C）下的稳定性令人满意。候选 BRP 由欧洲药典委员会作为 Ph. Eur. HCV RNA 用于 NAT 测试 BRP 批 2 建立，效力赋值为 960IU/瓶。它将在 EDQM 下以目录号 H0215000 提供。
