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International Collaborative Study of Assay of Anti‐D (Anti‐Rh o ) Immunoglobulin
Author(s) -
Bangham D. R.,
Kirkwood T. B. L.,
Wybrow G.,
HughesJones N. C.,
Gunson H. H.
Publication year - 1978
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/j.1365-2141.1978.tb01061.x
Subject(s) - ampoule , antibody , serial dilution , immunoglobulin g , chemistry , blood donations , chromatography , medicine , immunology , blood donor , organic chemistry , pathology , alternative medicine
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 μg 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 μg of IgG anti‐D immunoglobulin ≡ 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 μg of IgG anti‐D immunoglobulin) for control of clinical preparations.