Bangham D R, Kirkwood T B, Wybrow G, Hughes-Jones N C, Gunson H H
Br J Haematol. 1978 Mar;38(3):407-23. doi: 10.1111/j.1365-2141.1978.tb01061.x.
An international collaborative study of anti-D assays has been carried out by 21 laboratories in 11 countries. Samples of anti-D immunoglobulin assayed in this study included two dilutions of a preparation used in clinical trials to determine a dose-protection relation, a national standard, commercial clinical preparations and the proposed international reference preparation in coded ampoules. Manual, automated haemagglutination and isotope labelling methods all gave similar relative potencies. Several of these estimates were significantly (P=0.95) heterogeneous and some modifications to improve assay design and procedure are suggested. The coded preparation was shown to be stable and suitable for comparative assays. It was estimated to contain 60 microgram of of anti-D IgG immunoglobulin per ampoule, and 150 i.u./ampoule when assayed against the International Standard for Incomplete Anti-D Blood Typing Serum. Thus for this preparation 1 microgram of IgG anti-D immunoglobulin identical to 2.5 i.u. anti-D antibody. At its 28th meeting the Expert Committee on Biological Standardization of WHO established the preparation 68/419 as the International Reference Preparation of Anti-D Immunoglobulin and assigned to it a potency of 150 i.u. per ampoule. The Preparation has been widely used (with a nominal content of 60 microgram of IgG anti-D immunoglobulin) for control of clinical preparations.
11个国家的21个实验室开展了一项抗D检测的国际合作研究。本研究中检测的抗D免疫球蛋白样本包括两种用于临床试验以确定剂量保护关系的制剂稀释液、一种国家标准品、商业临床制剂以及编码安瓿中的拟国际参考制剂。手工、自动血凝和同位素标记方法所得的相对效价相似。其中一些估计值存在显著（P = 0.95）异质性，并建议对检测设计和程序进行一些改进。编码制剂显示稳定且适用于比较检测。据估计，每安瓿含有60微克抗D IgG免疫球蛋白，以不完全抗D血型血清国际标准品进行检测时为150国际单位/安瓿。因此，对于该制剂，1微克IgG抗D免疫球蛋白等同于2.5国际单位抗D抗体。世界卫生组织生物标准化专家委员会在其第28次会议上确定68/419制剂为抗D免疫球蛋白国际参考制剂，并指定其效价为每安瓿150国际单位。该制剂（标称含60微克IgG抗D免疫球蛋白）已广泛用于临床制剂的对照。
