Detection of antibodies directed to the N-terminal region of GAD is dependent on assay format and contributes to differences in the specificity of GAD autoantibody assays for type 1 diabetes
Open accessAbstract
GAD autoantibodies (GADAs) are sensitive markers of islet autoimmunity and type 1 diabetes. They form the basis of robust prediction models and are widely used for the recruitment of subjects at high risk of type 1 diabetes to prevention trials. However, GADAs are also found in many individuals at low risk of diabetes progression. To identify the sources of diabetes-irrelevant GADA reactivity, we analyzed data from the 2009 and 2010 Diabetes Autoantibody Standardization Program GADA workshop and found that binding of healthy control sera varied according to assay type. The characterization of control sera found positive by radiobinding assay (RBA), but negative by ELISA, showed that many of these sera reacted to epitopes in the N-terminal region of the molecule. This finding prompted development of an N-terminally truncated GAD65 radiolabel, 35S-GAD65(96–585), which improved the performance of most GADA RBAs participating in an Islet Autoantibody Standardization Program GADA substudy. These detailed workshop comparisons have identified a source of disease-irrelevant signals in GADA RBAs and suggest that N-terminally truncated GAD labels will enable more specific measurement of GADAs in type 1 diabetes.
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Measurement of autoantibodies using a truncated radiolabel [GAD(96-585)] improves specificity compared with using full-length antigen.
“while measurement of autoantibodies using a truncated radiolabel [GAD(96–585)] improves specificity compared with using full‐length antigen [ 7 ].”
From Islet autoantibody profiles associated with higher diabetes risk in Lithuanian compared with English schoolchildren (2020) · cites this paper as [7]
The Results (Evaluation of GAD65(96–585) in the IASP 2012 GADA Substudy; page not provided) report higher adjusted sensitivity at 95% specificity with the truncated radiolabel than with full-length GAD65 in 8 of 10 laboratories. The Abstract suggests that truncated labels will enable more specific measurement, but the paper does not establish an unqualified improvement in specificity across assays. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThe specificity of GADA assays is low in low-prevalence populations, yielding a heterogeneous group of true positives (autoimmune T1DM) and false positives (non-autoimmune T2DM).
“Additionally, the specificity of GADA assays is low in low-prevalence populations, yielding a heterogeneous group of true positives (autoimmune T1DM) and false positives (non-autoimmune T2DM)91.”
From The epidemiology of type 1 diabetes mellitus in older adults (2025) · cites this paper as [91]
The Introduction and Discussion report that GADA assay specificity varies and that false-positive results occur in healthy controls. The Results report a median specificity of 94% in the DASP 2010 workshop. The paper does not establish that specificity is generally low in low-prevalence populations or identify the false positives as people with non-autoimmune type 2 diabetes. (LLM, conf=0.87)
Experimental — accuracy not yet measured
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- Authors
- Williams, A. J. K., Lampasona, V., Schlosser, M., Mueller, P. W., Pittman, D. L., Winter, W. E., Akolkar, B., Wyatt, R., Brigatti, C., Krause, S., Achenbach, P., & Laboratories, P.
- Affiliations
- University of Bristol (GB)
- IRCCS Ospedale San Raffaele (IT)
- Universitätsmedizin Greifswald (DE)
- Centers for Disease Control and Prevention (US)
- University of Florida Health (US)
- National Institutes of Health (US)
- TUM Klinikum (DE)
- Corresponding author
- Williams, Alistair J.K.
- Participating Laboratories
- ORCID
- Venue
- Diabetes
- Publisher
- American Diabetes Association
- Published
- 2015-05-13
- Volume
- 64
- Issue
- 9
- Pages
- 3239-3246
- ISSN
- 0012-1797 (ISSN-L)
- 1939-327X
- PMC
- PMC4542444
- OpenAlex
- W2167007291
- Cited by
- 46
- References
- 30
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 4 · 2023: 2 · 2022: 3 · 2021: 6 · 2020: 2 · 2019: 6 · 2018: 6 · 2017: 4 · 2016: 8 · 2015: 3
- FWCI
- 4.78
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Diabetes (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Explore Bristol Research (publishedVersion, other-oa)
- Bristol Research (University of Bristol) (submittedVersion, other-oa)
- Site cant be reached (submittedVersion)
- PuSH - Publication Server of Helmholtz Zentrum München (submittedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Funders
- The Italian Ministry of Research (Ivascomar project, Cluster Tecnologico Nazionale S)
- National Institutes of Health (PL105-33, PL106-310, PL106-554, PL107-360)
- Associazione Italiana per la Ricerca sul Cancro (AIRC bando 5 × 1000 N_12182)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Life Sciences › Immunology and Microbiology › Immunology › T-cell and B-cell Immunology
- Keywords
- glutamic acid decarboxylase antibodies, GAD65, type 1 diabetes, islet autoimmunity, N-terminal epitope, assay specificity, radiobinding assay, ELISA
- MeSH terms
- Adolescent, Adult, Epitopes, Autoantibodies, Child, Diabetes Mellitus, Type 1, Enzyme-Linked Immunosorbent Assay, Female, Glutamate Decarboxylase, Humans, Male, Middle Aged, Radioligand Assay, Sensitivity and Specificity, Case-Control Studies, Young Adult
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Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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