The third international standard for anti-D immunoglobulin: international collaborative study to evaluate candidate preparations.
Vox Sang
; 114(7): 740-748, 2019 Oct.
Article
em En
| MEDLINE
| ID: mdl-31321786
BACKGROUND AND OBJECTIVES: The purpose of the study was to evaluate a lyophilized anti-D immunoglobulin preparation to serve as a replacement WHO International Standard for the calibration of potency assays of anti-D immunoglobulin products. Such products are used to prevent haemolytic disease of the foetus and newborn due to maternal alloanti-D. MATERIALS AND METHODS: The candidate 3rd International Standard for anti-D immunoglobulin (16/332) was evaluated and calibrated against the 2nd International Standard for anti-D immunoglobulin (01/572), along with a coded duplicate, a second candidate preparation (16/278) and a comparability sample (16/272) in an international collaborative study. Twenty of 21 laboratories in 15 countries performed one or more of the three European Pharmacopoeia reference methods. RESULTS: The overall geometric mean potency (from all methods) of the candidate 3rd International Standard, 16/332, was 296·6 IU/ampoule, with inter-laboratory variability, expressed as % GCV, of 4·7%. SE-HPLC of the immunoglobulin preparations demonstrated combined monomeric and dimeric IgG peak areas of >95% for all samples. Accelerated stability studies have shown both 16/332 and 16/278 to be very stable for long-term storage at -20°C. CONCLUSIONS: Preparation 16/332 was established by the World Health Organisation Expert Committee on Biological Standardization as the 3rd International Standard for anti-D immunoglobulin with an assigned potency of 297 IU/ampoule.
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Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Técnicas Imunoenzimáticas
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Imunoglobulina rho(D)
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Técnicas de Diagnóstico Molecular
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Eritroblastose Fetal
Tipo de estudo:
Diagnostic_studies
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Evaluation_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article