Diabetes Antibody Standardization Program: evaluation of assays for autoantibodies to glutamic acid decarboxylase and islet antigen-2
Open accessAbstract
Aims/hypothesis Islet autoantibodies are important in diabetes classification and risk assessment, and as endpoints in observational studies. The Diabetes Autoantibody Standardization Program (DASP) aims to improve and standardise measurement of autoantibodies associated with type 1 diabetes. We report results for glutamic acid decarboxylase autoantibodies (GADA) and islet antigen-2 autoantibodies (IA-2A) from three DASP workshops (2002--2005). Methods Up to 60 laboratories in 18 countries participated in each workshop. Participants received coded serum aliquots from 50 patients with newly diagnosed type 1 diabetes (median age 18 years, range 9-35 years) and 100 blood donor controls. Results were analysed using receiver operator characteristic (ROC) curves with sensitivity adjusted to 95% specificity in workshop controls. Results GADA assays performed well in all three workshops (median area under the ROC curve [AUC] 0.94; interquartile range 0.91-0.95) and performance was similar to DASP 2000. Performance of IA-2A assays improved over the workshop programme. Median AUC was 0.81 (interquartile range 0.79-0.83) in DASP 2002, 0.82 (interquartile range 0.78-0.84) in 2003, and 0.85 (interquartile range 0.82-0.87) in 2005 (p < 0.0001). Performance of GADA ELISA improved between 2002 and 2005, and, in DASP 2005, achieved higher median AUC and adjusted sensitivity than RIA. IA-2A ELISA improved and, in DASP 2005, achieved AUCs equivalent to in-house RIA. Assays using IA-2ic or full length IA-2 clones were more sensitive than those using IA-2bdc, with higher AUC (p = 0.004). Conclusions/interpretation GADA and IA-2A assays perform well in discriminating health and disease. The workshop format highlights systematic differences related to assay method and allows full evaluation of novel methods. The programme of autoantibody workshops in type 1 diabetes provides a model for other autoimmune diseases.
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Participation of commercially available GAD65A and IA-2A methods in the DASP program demonstrates that harmonization and eventual standardization of these assays should be possible.
“That commercially available GAD65A and IA-2A methods are also participating in the DASP program demonstrates that it should be possible not only to harmonize participating laboratories but also eventually to standardize GAD65A and IA-2A (311).”
From Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus (2011) · cites this paper as [311]
Major efforts have been made to standardize GAD65A and IA-2A measurements.
“Major efforts have been made to standardize GAD65A and IA-2A measurements (309,311).”
From Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus (2011) · cites this paper as [311]
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- Authors
- Törn, C., Mueller, P. W., Schlosser, M., Bonifacio, E., Bingley, P. J., & Laboratories, P.
- Affiliations
- Centers for Disease Control and Prevention (US)
- Universität Greifswald (DE)
- Center for Regenerative Therapies Dresden (DE)
- Southmead Hospital (GB)
- Corresponding author
- Bingley, P. J.
- Venue
- Diabetologia
- Published
- 2008-03-29
- Volume
- 51
- Issue
- 5
- Pages
- 846-852
- ISSN
- 0012-186X (ISSN-L)
- 1432-0428
- OpenAlex
- W2098742390
- Cited by
- 284
- References
- 19
- Citations by year
- 2026: 9 · 2025: 6 · 2024: 7 · 2023: 14 · 2022: 15 · 2021: 14 · 2020: 7 · 2019: 17 · 2018: 13 · 2017: 12 · 2016: 20 · 2015: 16 · 2014: 19 · 2013: 23 · 2012: 27
- FWCI
- 11.43
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Diabetologia (publishedVersion)
- PubMed (publishedVersion)
- Bristol Research (University of Bristol) (publishedVersion)
- Nova Science Publishers (Nova Science Publishers, Inc.) (submittedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Funders
- National Institutes of Health (PL105-33)
- Centers for Disease Control and Prevention (106-554, PL 105-33, 107-360, 106-310)
- U.S. Public Health Service (106-554, PL105-33, 106-310, 107-360)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Keywords
- type 1 diabetes, islet autoantibodies, glutamic acid decarboxylase antibodies, assay standardization, sensitivity and specificity, newly diagnosed type 1 diabetes
- MeSH terms
- Autoantibodies, Diabetes Mellitus, Glutamate Decarboxylase, Humans, ROC Curve, Sensitivity and Specificity, Receptor-Like Protein Tyrosine Phosphatases, Class 8
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