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Åke Lernmark

Principal investigator

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The development of a World Health Organisation international standard for islet cell antibodies : The aims and design of an international collaborative study

Author

  • Anthony R. Mire-Sluis
  • Rose Gaines Das
  • Åke Lernmark

Summary, in English

Islet cell antibodies (ICA) are a specific marker for Type 1 (insulin-dependent) 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. Proficiency 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 significantly 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 difficult 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.

Publishing year

1999-01-01

Language

English

Pages

72-77

Publication/Series

Diabetes/Metabolism Research and Reviews

Volume

15

Issue

1

Document type

Journal article

Publisher

John Wiley and Sons

Keywords

  • Assays
  • Autoantibodies
  • Islet cell antibodies
  • Standardisation

Status

Published

ISBN/ISSN/Other

  • ISSN: 1520-7552