The DOI matches its Crossref record; 18 of the 18 references it cites were found in a registry or an index.
The World Health Organization International Collaborative Study for Islet Cell Antibodies
Open accessAbstract
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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“ICA tests measure the degree of binding of immunoglobulin to islet sections and are compared with a WHO standard serum available from the National Institute of Biological Standards and Control (437).”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [437]
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“A WHO standard for both GAD65A and IA-2A has been established, and GAD65A and IA-2A amounts are expressed in international units (312).”
From Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus (2011) · cites this paper as [312]
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Citations
Cites
ISLET-CELL ANTIBODIES IN DIABETES MELLITUS WITH AUTOIMMUNE POLYENDOCRINE DEFICIENCIES
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Serum exchange and use of dilutions have improved precision of measurement of islet cell antibodies
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Self-citationDepartment of Biochemistry and Molecular Biology
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Can Islet Cell Antibodies Predict IDDM in the General Population?
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Katsarou, A., Gudbjörnsdottir, S., Rawshani, A., Dabelea, D., Bonifacio, E., Anderson, B. J., Jacobsen, L. M., Schatz, D. A., & Lernmark, Å. (2017) · Nature Reviews Disease Primers · doi:10.1038/nrdp.2017.16 · Cited by 1,475
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Self-citationSacks, D. B., Bruns, D. E., Goldstein, D. E., Maclaren, N. K., McDonald, J. M., & Parrott, M. A. (2002) · Clinical Chemistry · doi:10.1093/clinchem/48.3.436 · Cited by 1,132
Davidson, A., & Diamond, B. (2001) · New England Journal of Medicine · doi:10.1056/nejm200108023450506 · Cited by 1,069
Sacks, D. B., Arnold, M., Bakris, G. L., Bruns, D. E., Horvath, A. R., Kirkman, M. S., Lernmark, A., Metzger, B. E., & Nathan, D. M. (2011) · Diabetes Care · doi:10.2337/dc11-9998 · Cited by 718
Metadata
- 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
- Semantic Scholar
- f25a86ccbfb50050779bc7e3089b8248436654e9
- 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
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- 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 › Health Professions › Medical Laboratory Technology › 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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