Cited by 122Diabetes and associated disordersClinical Laboratory Practices and Quality ControlDiabetes Management and Research

The World Health Organization International Collaborative Study for islet cell antibodies

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Mire-Sluis, A. R., Gaines Das, R., Lernmark, Å.·2000·Diabetologia

Abstract

Aims/hypothesis Islet cell autoantibodies are a specific marker for Type 1 (insulin-dependent) diabetes mellitus. Standardisation of islet cell antibodies and the uniform reporting in International units is critical to research and the development of assays for islet cell autoantibodies as diagnostics.Methods The suitability of a candidate serum to serve as the international standard for islet cell antibodies was studied by 19 participants in 8 countries. In addition, the purpose was to investigate whether the serum could also serve as a standard for antibodies to the 65000 Mr isoform of glutamic acid decarboxylase (GAD65) and islet antigen-2 (IA-2). Control sera were included in the study to assess the validity of the various assay systems. The sera were lyophilized to World Health Organization criteria and the candidate serum assigned the ampoule code number 97/550.Results The use of 97/550 was shown to notably reduce inter laboratory variability in the measurement of islet cell antibodies. In addition, there was a pronounced reduction in inter laboratory variability in the measurement of GAD65 and IA-2 antibodies.Conclusions/interpretation On the basis of the results reported here and with agreement of the participants, the preparation 97/550 has been established by the World Health Organization Expert Committee on Biological Standards for establishment as the first international standard for islet cell antibodies, with an assigned potency of 20 international units. In addition, 97/550 can serve as an international reference reagent for specific GAD65 antibodies, with an assigned potency of 100 units. It can also serve as a National Institute of Biological Standards and Control (NIBSC) reference reagent for IA-2 antibodies for evaluation of assays for this material.

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Research works printed but not linked: 3

  1. [7]7. Bottazzo GF, Gleichmann H (1986) Workshop Report: Im- munology and diabetes workshops: Report of the first in- ternational workshop on the standardisation of cytoplasmic islet cell antibodies. Diabetologia 29: 125±126
  2. [8]8. Bonifacio E, Dawkins RL, Lernmark A (1987) Immunolo- gy and diabetes workshops: Report of the second interna- tional workshop on the standardization of cytoplasmic islet cell antibodies. Diabetologia 30: 273
  3. [10]10. Lernmark A, Molenaar JL, van Beers WA et al. (1991) The Fourth International Serum Exchange Workshop to stan- dardize cytoplasmic islet cell antibodies. The Immunology and Diabetes Workshops and Participating Laboratories. Diabetologia 34: 534±535

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Authors
Mire-Sluis, A. R., Gaines Das, R., & Lernmark, &.
Venue
Diabetologia
Published
2000-10-02
Volume
43
Issue
10
Pages
1282-1292
ISSN
  • 0012-186X (ISSN-L)
  • 1432-0428
OpenAlex
W2091765481
Cited by
122
References
16
Citations by year
2026: 3 · 2025: 1 · 2024: 2 · 2023: 5 · 2022: 3 · 2021: 1 · 2020: 3 · 2019: 5 · 2018: 1 · 2017: 2 · 2016: 5 · 2015: 3 · 2014: 2 · 2013: 6 · 2012: 5
FWCI
4.86
Type
journal article
Language
en
Open access
Locations
  • Diabetologia (publishedVersion)
  • PubMed (publishedVersion)
  • Lund University Publications (Lund University) (submittedVersion)
  • VUBIR (Vrije Universiteit Brussel) (submittedVersion)
Funders
  • University of Washington
  • King's College London
  • University of Bristol
  • Monash University
  • National Institute of Diabetes and Digestive and Kidney Diseases (R01DK026190)
  • College of Medicine, University of Florida
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Keywords
islet cell antibodies, type 1 diabetes, international standards, GAD65 antibodies, IA-2 autoantibodies, inter-laboratory variability, reference reagents, antibody potency
MeSH terms
Autoantibodies, Diabetes Mellitus, Type 1, Fluorescent Antibody Technique, Glutamate Decarboxylase, Humans, Islets of Langerhans, Laboratories, Quality Control, Reference Standards, World Health Organization

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