Thorpe S J, Sands D, Fox B, Behr-Gross M-E, Schäffner G, Yu M W
National Institute for Biological Standards and Control, Potters Bar, Herts, UK.
Vox Sang. 2003 Nov;85(4):313-21. doi: 10.1111/j.0042-9007.2003.00367.x.
The aim of the study was to evaluate a lyophilized anti-D immunoglobulin preparation to serve as a global standard for potency assays of anti-D immunoglobulin products.
The candidate global standard, 01/572, was calibrated against the World Health Organization (WHO) International Reference Preparation (IRP) for anti-D immunoglobulin, human (68/419), along with two reserve candidate reference preparations, in an international collaborative study involving 25 laboratories in 15 countries. The United States Food and Drug Administration (US-FDA) Center for Biologics Evaluation and Research (CBER) Standard for anti-D immunoglobulin, Lot 3, was included for comparison. Most laboratories (20/25) performed AutoAnalyser methodology, competitive enzyme-linked immunoassay (EIA) and/or flow cytometry.
The overall mean potency of the candidate global standard, 01/572, was 284.5 international units (IU)/ampoule, with an interlaboratory variability, expressed as a percentage geometric coefficient of variation (% gcv), of 9.7. The mean potency of the US Standard was 859.4 IU/ml with an interlaboratory variability of 9.5% gcv, excluding an outlier. The mean potencies of the reserve preparations per ampoule/vial were 110.6 IU and 106.7 IU when calibrated against the IRP, and 112.2 IU and 106.6 IU when calibrated against 01/572, respectively, with interlaboratory % gcv values of 9.6-18.3 (excluding outliers).
Preparation 01/572 proved more suitable for use as a global standard than the reserve candidate preparations and was established, with an assigned potency of 285 IU/ampoule, by the WHO as the 2nd International Standard for anti-D immunoglobulin; by FDA-CBER as the Standard for anti-D immunoglobulin, Lot 4; and by the European Directorate for the Quality of Medicines (EDQM) as the 1st Biological Reference Preparation for anti-D immunoglobulin.
本研究旨在评估一种冻干抗-D免疫球蛋白制剂，以作为抗-D免疫球蛋白产品效价测定的全球标准。
在一项涉及15个国家25个实验室的国际协作研究中，将候选全球标准品01/572与世界卫生组织（WHO）人抗-D免疫球蛋白国际参考制剂（IRP）（68/419）以及两种备用候选参考制剂进行校准。美国食品药品监督管理局（US-FDA）生物制品评估和研究中心（CBER）的抗-D免疫球蛋白标准品3号批次也纳入比较。大多数实验室（20/25）采用自动分析仪方法、竞争性酶联免疫吸附测定（EIA）和/或流式细胞术。
候选全球标准品01/572的总体平均效价为每安瓿284.5国际单位（IU），实验室间变异以几何变异系数百分比（% gcv）表示为9.7。美国标准品的平均效价为859.4 IU/ml，实验室间变异为9.5% gcv（排除一个异常值）。当与IRP校准时，备用制剂每安瓿/每瓶的平均效价分别为110.6 IU和106.7 IU，当与01/572校准时，分别为112.2 IU和106.6 IU，实验室间% gcv值为9.6 - 18.3（排除异常值）。
制剂01/572被证明比备用候选制剂更适合作为全球标准，并被WHO确立为抗-D免疫球蛋白的第2个国际标准，效价指定为285 IU/安瓿；被FDA-CBER确立为抗-D免疫球蛋白标准品4号批次；被欧洲药品质量理事会（EDQM）确立为抗-D免疫球蛋白的第1个生物参考制剂。
