Islet Autoantibody Standardization Program 2018 workshop: interlaboratory comparison of glutamic acid decarboxylase autoantibody assay performance
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BACKGROUND: The Islet Autoantibody Standardization Program (IASP) aims to improve the performance of immunoassays measuring type 1 diabetes (T1D)-associated autoantibodies and the concordance of results among laboratories. IASP organizes international interlaboratory assay comparison studies in which blinded serum samples are distributed to participating laboratories, followed by centralized collection and analysis of results, providing participants with an unbiased comparative assessment. In this report, we describe the results of glutamic acid decarboxylase autoantibody (GADA) assays presented in the IASP 2018 workshop. METHODS: In May 2018, IASP distributed to participants uniquely coded sera from 43 new-onset T1D patients, 7 multiple autoantibody-positive nondiabetic individuals, and 90 blood donors. Results were analyzed for the following metrics: sensitivity, specificity, accuracy, area under the ROC curve (ROC-AUC), partial ROC-AUC at 95% specificity (pAUC95), and concordance of qualitative and quantitative results. RESULTS: Thirty-seven laboratories submitted results from a total of 48 different GADA assays adopting 9 different formats. The median ROC-AUC and pAUC95 of all assays were 0.87 [interquartile range (IQR), 0.83–0.89] and 0.036 (IQR, 0.032–0.039), respectively. Large differences in pAUC95 (range, 0.001–0.0411) were observed across assays. Of formats widely adopted, bridge ELISAs showed the best median pAUC95 (0.039; range, 0.036–0.041). CONCLUSIONS: Several novel assay formats submitted to this study showed heterogeneous performance. In 2018, the majority of the best performing GADA immunoassays consisted of novel or established nonradioactive tests that proved on a par or superior to the radiobinding assay, the previous gold standard assay format for GADA measurement.
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The performance of GADA and IA-2A assays is improving, as demonstrated by the Islet Autoantibody Standardization Program.
“The performance of GADA and IA-2A assays is improving, as demonstrated by the Islet Autoantibody Standardization Program (440,442).”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [442]
The Abstract Conclusions and Discussion report high-performing GADA assays, including nonradioactive formats that performed as well as or better than the previous gold-standard format. But this 2018 comparison does not establish a trend of improvement over time, and it evaluates GADA assays, not IA-2A assays. No page numbers are provided in our copy. (LLM, conf=0.85)
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Precision Diagnostics: Using Islet Autoantibodies to Characterize Heterogeneity in Type 1 DiabetesPreprint
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Prevalence of Islet Autoantibodies in Adults Without Diabetes
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Self-citationMistaken Identity: The Role of Autoantibodies in Endocrine Disease
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Pancreas Islet Cell-Specific Antibody Detection by ELISA
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A comparison of current methods to measure antibodies in type 1 diabetes
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Self-citationDefinition, Klassifikation, Diagnostik und Differenzialdiagnostik des Diabetes mellitus: Update 2025
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Characterisation of islet antibody‐negative type 1 diabetes mellitus in Indian children
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Prevalence of Thyroid Peroxidase and Thyroglobulin Autoantibodies in the Swedish Population
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Type 1 Diabetes Autoantibodies in Acute, Recurrent Acute, and Chronic Pancreatitis
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Self-citationNeue Klassifikation des Diabetes mellitus – Anforderungen an Labormessgrößen
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Self-citationEvaluation of Biochemical Characteristics and Performance of the 3 Screen ICA ELISA Kit
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Self-citationIslet autoantibody positivity in an adult population with recently diagnosed diabetes in Uganda
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Definition, Klassifikation, Diagnostik und Differenzialdiagnostik des Diabetes mellitus: Update 2024
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Lada or Type 2 Diabetes Mellitus - A Challenging Diagnosis in Clinical Approach
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Definition, Klassifikation, Diagnostik und Differenzialdiagnostik des Diabetes mellitus: Update 2023
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Definition, Klassifikation, Diagnostik und Differenzialdiagnostik des Diabetes mellitus: Update 2025
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- Authors
- Lampasona, V., Pittman, D. L., Williams, A. J., Achenbach, P., Schlosser, M., Akolkar, B., Winter, W. E., Laboratories, P., Watson, K., Weets, I., Tao, Y., Chen, V, Yang, Y., Uibo, R., Reimand, K., Knip, M., Härkönen, T., Chatenoud, L., Achenbach, P., Neidhoefer, S., Schlosser, M., Lampasona, V, Kawasaki, E., Batstra, M. R., Cieremans, T., Almås, B., Opsion, K. S., Wyka, K., Castaño, L., Ramelius, A., Johansson, I., Williams, A., Furmaniak, J., McDonald, T., McLaughlin, K., Christie, M., Metz, A., Mathew, A., Hampe, C., Lu, C., Wasserfall, C., Mann, C., Pittman, D., Ananta, J. S., Yu, L., Mamula, M., Robinson, P., Gaur, V, & Hagopian, W. A.
- Affiliations
- San Raffaele Diabetes Research Institute, IRCCS San Raffaele Hospital, Milan, Italy
- University of Florida Health (US)
- Diabetes and Metabolism, Translational Health Sciences, University of Bristol, Bristol, UK
- Institute of Diabetes Research, Helmholtz Center Munich, German Research Center for Environmental Health, Neuherberg, Germany
- Department of Surgery, University Medical Center Greifswald, Greifswald, Germany
- National Institutes of Health (US)
- The Royal Melbourne Hospital (AU)
- Jiangsu Province Hospital (CN)
- Helmholtz Munich (DE)
- Shenzhen YHLO Biotech Co., Ltd. (China) (CN)
- National Institute of Diabetes and Digestive and Kidney Diseases (US)
- University of Helsinki (FI)
- Hôpital Necker-Enfants Malades (FR)
- Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany
- Universitätsmedizin Greifswald (DE)
- Department of Surgery, University Medical Center Greifswald, Karlsburg, Germany
- San Raffaele Diabetes Research Institute, IRCCS Istituto Scientifico San Raffaele, Milano, Italy
- Reinier de Graaf Hospital (NL)
- Haukeland University Hospital (NO)
- Oslo University Hospital (NO)
- Medical University of Lodz (PL)
- Lund University (SE)
- Linköping University (SE)
- Diabetes & Metabolism, Learning & Research, University of Bristol, Bristol, UK
- Royal Devon & Exeter NHS Foundation Trust (GB)
- Wave 80 Biosciences (United States) (US)
- University of Washington (US)
- Meso Scale Discovery, Gaithersburg, MD, USA
- University of Florida (US)
- University of Florida Health Pathology Laboratories, University of Florida Health Pathology Laboratories, Gainesville, FL
- Nirmidas Biotech INC, Palo Alto, CA, USA
- Yale University (US)
- Pacific Northwest Research Institute (US)
- ORCID
- Venue
- Clinical Chemistry
- Publisher
- Oxford University Press (OUP)
- Published
- 2019-09-01
- Volume
- 65
- Issue
- 9
- Pages
- 1141-1152
- ISSN
- 0009-9147 (ISSN-L)
- 1530-8561
- PMC
- PMC8936135
- OpenAlex
- W2967824496
- Semantic Scholar
- 569f027789613fb5b5a575518f1296a9c5e5fde0
- Cited by
- 103
- References
- 38
- Citations by year
- 2026: 8 · 2025: 16 · 2024: 17 · 2023: 21 · 2022: 14 · 2021: 17 · 2020: 9
- FWCI
- 6.01
- Type
- journal article
- Language
- en
- Open access
- Licence
- Locations
- Clinical Chemistry (publishedVersion)
- PubMed (publishedVersion)
- Bristol Research (University of Bristol) (publishedVersion, other-oa)
- PubMed Central (acceptedVersion)
- Työväentutkimus Vuosikirja (submittedVersion)
- Site cant be reached (submittedVersion, other-oa)
- PuSH - Publication Server of Helmholtz Zentrum München (submittedVersion)
- Explore Bristol Research (submittedVersion, other-oa)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Funders
- IASP study
- University of South Florida
- IASP Ancillary studies
- 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
- glutamic acid decarboxylase antibodies, type 1 diabetes, islet autoantibodies, assay standardization, interlaboratory comparison, immunoassay performance, radiobinding assay, assay concordance, sensitivity and specificity
- MeSH terms
- Adolescent, Adult, Autoantibodies, Child, Diabetes Mellitus, Type 1, Education, Female, Glutamate Decarboxylase, Humans, Immunoassay, Male, Middle Aged, Reference Standards, ROC Curve, Young Adult
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