The development of a World Health Organisation international standard for islet cell antibodies: the aims and design of an international collaborative study
✍ Scribed by Anthony R. Mire-Sluis; Rose Gaines Das; Åke Lernmark
- Publisher
- John Wiley and Sons
- Year
- 1999
- Tongue
- English
- Weight
- 69 KB
- Volume
- 15
- Category
- Article
- ISSN
- 1520-7552
No coin nor oath required. For personal study only.
✦ Synopsis
Islet cell antibodies (ICA) are a speci®c marker for Type 1 (insulindependent) diabetes mellitus. ICA are found in the serum of over 80% of newly diagnosed patients and the levels of ICA are directly of prognostic value. Standardisation of ICA and the uniform reporting of ICA levels in international units is critical to preclinical/clinical research and the development of assays for ICA as diagnostics, in particular for the differential diagnosis of late onset Type 1 and Type 2 diabetes. Pro®ciency studies carried out by the Immunology of Diabetes Workshops on Standardization have clearly shown that a single reference material, serum sample 673, obtained by Dr J. Ludvigsson, has signi®cantly reduced inter-and intra-assay variability in the reporting of ICA levels. Nevertheless, this material is a frozen serum of limited shelf-life and is dif®cult to distribute on a worldwide and routine basis. Therefore, the Immunology of Diabetes Workshop Standardization Committee and the Juvenile Diabetes Foundation International requested that the National Institute for Biological Standards and Control (NIBSC) organise an international collaborative study to compare the activities of lyophilised, stable ICA preparations. In addition, the purpose was to investigate if sample 673 could also serve as a standard for GAD65 and IA-2 antibodies. Twenty participants in eight countries have been recruited to the study.