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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

Mire-Sluis, Anthony R. ; Das, Rose Gaines and Lernmark, Åke LU orcid (1999) In Diabetes/Metabolism Research and Reviews 15(1). p.72-77
Abstract

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... (More)

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.

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Please use this url to cite or link to this publication:
author
; and
publishing date
type
Contribution to journal
publication status
published
keywords
Assays, Autoantibodies, Islet cell antibodies, Standardisation
in
Diabetes/Metabolism Research and Reviews
volume
15
issue
1
pages
72 - 77
publisher
John Wiley & Sons Inc.
external identifiers
  • pmid:10398550
  • scopus:0032993872
ISSN
1520-7552
DOI
10.1002/(SICI)1520-7560(199901/02)15:1<72::AID-DMRR11>3.0.CO;2-G
language
English
LU publication?
no
id
75d251be-3116-409e-9a1c-537e038e80bf
date added to LUP
2019-06-30 23:30:16
date last changed
2024-03-13 08:09:43
@article{75d251be-3116-409e-9a1c-537e038e80bf,
  abstract     = {{<p>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.</p>}},
  author       = {{Mire-Sluis, Anthony R. and Das, Rose Gaines and Lernmark, Åke}},
  issn         = {{1520-7552}},
  keywords     = {{Assays; Autoantibodies; Islet cell antibodies; Standardisation}},
  language     = {{eng}},
  month        = {{01}},
  number       = {{1}},
  pages        = {{72--77}},
  publisher    = {{John Wiley & Sons Inc.}},
  series       = {{Diabetes/Metabolism Research and Reviews}},
  title        = {{The development of a World Health Organisation international standard for islet cell antibodies : The aims and design of an international collaborative study}},
  url          = {{http://dx.doi.org/10.1002/(SICI)1520-7560(199901/02)15:1<72::AID-DMRR11>3.0.CO;2-G}},
  doi          = {{10.1002/(SICI)1520-7560(199901/02)15:1<72::AID-DMRR11>3.0.CO;2-G}},
  volume       = {{15}},
  year         = {{1999}},
}