Ferguson M, Sands D, Lelie N
National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Herts, EN6 3QG, UK.
Biologicals. 2000 Dec;28(4):233-40. doi: 10.1006/biol.2000.0262.
A collaborative study was carried out to assess the suitability of a candidate replacement material for the International Standard for hepatitis A immunoglobulin, which was found to be reactive for HCV RNA, and to calibrate it in International Units. The candidate standard, coded 97/646, was derived from a bulk of 16% immunoglobulin supplied by the Central Laboratory of the Netherlands Red Cross, Amsterdam, and diluted 1 in 2 in H2O resulting in a final immunoglobulin concentration of 8%. Sixteen laboratories from 11 countries participated in the study and contributed data from 64 assays performed using six commercial assay kits and four in-house methods. All assays were analysed as parallel line bioassays comparing assay response with log concentration. The overall mean potency of the candidate replacement immunoglobulin standard, 97/646, relative to the International Standard for hepatitis A immunoglobulin, was 98.6 IU/ml. A freeze-dried serum preparation, 97/648, was also calibrated in this study and had a potency of 22.64 IU/ml. The Second International Standard for hepatitis A immunoglobulin, human, was established by the World Health Organisation Expert Committee on Biological Standardisation in 1998 with a potency of 49 IU per ampoule when reconstituted in 0.5 ml.
开展了一项合作研究，以评估一种候选替代材料是否适合甲型肝炎免疫球蛋白国际标准品，该标准品被发现对丙型肝炎病毒核糖核酸呈反应性，并对其进行国际单位校准。编码为97/646的候选标准品源自荷兰红十字会阿姆斯特丹中央实验室提供的16%免疫球蛋白原液，在水中按1:2稀释，最终免疫球蛋白浓度为8%。来自11个国家的16个实验室参与了该研究，并提供了使用6种商业检测试剂盒和4种内部方法进行的64次检测的数据。所有检测均作为平行线生物检测进行分析，将检测反应与对数浓度进行比较。相对于甲型肝炎免疫球蛋白国际标准品，候选替代免疫球蛋白标准品97/646的总体平均效价为98.6 IU/ml。一种冻干血清制剂97/648也在本研究中进行了校准，效价为22.64 IU/ml。人用甲型肝炎免疫球蛋白第二国际标准品由世界卫生组织生物标准化专家委员会于1998年制定，复溶至0.5 ml时每安瓿效价为49 IU。
