International Collaborative Study of Assay of Anti‐D (Anti‐Rho) Immunoglobulin

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Abstract
An international collaborative study of [human] anti-D assay was carried out by 21 laboratories in 11 countries. Samples of anti-D immunoglobulin [Ig] assayed in this study included 2 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 hemagglutination and isotope labeling 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 stable and suitable for comparative assays. It was estimated to contain 60 .mu.g of anti-D IgG/ampoule, and 150 IU/ampoule when assayed against the International Standard for Incomplete Anti-D Blood Typing Serum. For this preparation 1 .mu.g of IgG anti-D .simeq. 2.5 IU anti-D antibody. At its 28th meeting the Expert Committee on Biological Standardization of the WHO established the preparation 68/419 as the International Reference Preparation of Anti-D immunoglobulin and assigned to it a potency of 150 IU per ampoule. This preparation was widely used (with a nominal content of 60 .mu.g of IgG anti-D) for control of clinical preparations.