ArticleDiabetologia2023
Islet Autoantibody Standardization Program: interlaboratory comparison of insulin autoantibody assay performance in 2018 and 2020 workshops.
Article in Diabetologia, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 2 of them syntheses that pooled it.
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41 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.
- Polish Recommendations for the Early Detection of Type 1 Diabetes in the Pediatric Population: A Position Statement of the Polish Society of Pediatric Endocrinology and Diabetology and the Pediatric Section of the Diabetes Poland 2026.Hormone research in paediatrics · 2026Guideline
- Islet-autoantibodies in gestational diabetes and risk of progression to postpartum diabetes: a systematic review and meta-analysis.Frontiers in endocrinology · 2026Pooled it
- Islet Autoantibody Patterns Vary by Race and Ethnicity and Area Deprivation Index for Individuals at Risk for Type 1 Diabetes.Diabetes care · 2026Article
- International consensus guidance for general population screening for islet autoantibodies to diagnose early-stage type 1 diabetes: a nominal group technique process.Diabetologia · 2026Article
- Psychosocial aspects of early detection in type 1 diabetes: Language matters, decision making and support needs.Diabetic medicine : a journal of the British Diabetic Association · 2026Review
- GADA testing: preparation for adult general population screening.Diabetologia · 2026Article
- Improved prediction of symptomatic type 1 diabetes using a luciferase-based assay to measure (pro)insulin autoantibodies.Diabetic medicine : a journal of the British Diabetic Association · 2026Observational
- Screening and Monitoring for Presymptomatic Type 1 Diabetes: A Time for Action.Hormone research in paediatrics · 2026Review
- Accounting for Age-Related Increases in HbA1c More Accurately Quantifies Risk of Type 1 Diabetes Progression in Islet Autoantibody-Positive Adults.Diabetes care · 2026Observational
- Capillary Electrophoresis Immunoassay for Detection of Anti-insulin Antibodies.Journal of separation science · 2026Article
- Article
- Interlaboratory Evaluation of Multiplex Autoantibody Assay Performance in the Islet Autoantibody Standardization Program 2024 Workshop.Diabetes care · 2026Article
- Identifying Insulin Autoantibodies With Differential Risk in Type 1 Diabetes With a Novel Bridging ELISA.Diabetes · 2026Article
- Evolution of islet autoantibodies in the Environmental Determinants of Islet Autoimmunity (ENDIA) prospective cohort.Diabetologia · 2026Article
- Accounting for age-related increases in HbA1c more accurately quantifies risk of Type 1 Diabetes progression in islet autoantibody-positive adults.medRxiv : the preprint server for health sciences · 2026Article
- Identification of a type 1 diabetes-associated T cell receptor repertoire signature from the human peripheral blood.Science advances · 2026Article
- Heterogeneity between insulin and proinsulin in the potency for insulin autoantibodies in newly diagnosed type 1 diabetes children.Clinical and experimental immunology · 2026Article
- Diagnostic efficacy of fasting insulin-to-C-peptide ratio in exogenous insulin autoimmune syndrome.Frontiers in medicine · 2026Article
- Diagnostic utility of the insulin-to-C-peptide molar ratio in differentiating insulin autoimmune syndrome and exogenous insulin antibody syndrome from insulinoma.Frontiers in endocrinology · 2026Article
- Contrasting Adult and Pediatric Populations in a Cohort of At-Risk Relatives in The T1D TrialNet Pathway to Prevention Study.Diabetes care · 2025Article
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Authors and funding
10 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aims/hypothesisThe Islet Autoantibody Standardization Program (IASP) aims to improve the performance of immunoassays measuring autoantibodies in type 1 diabetes and the concordance of results across laboratories. IASP organises international workshops distributing anonymised serum samples to participating laboratories and centralises the collection and analysis of results. In this report, we describe the results of assays measuring IAA submitted to the IASP 2018 and 2020 workshops.
methodsThe IASP distributed uniquely coded sera from individuals with new-onset type 1 diabetes, multiple islet autoantibody-positive individuals, and diabetes-free blood donors in both 2018 and 2020. Serial dilutions of the anti-insulin mouse monoclonal antibody HUI-018 were also included. Sensitivity, specificity, area under the receiver operating characteristic curve (ROC-AUC), partial ROC-AUC at 95% specificity (pAUC95) and concordance of qualitative/quantitative results were compared across assays.
resultsResults from 45 IAA assays of seven different formats and from 37 IAA assays of six different formats were submitted to the IASP in 2018 and 2020, respectively. The median ROC-AUC was 0.736 (IQR 0.617-0.803) and 0.790 (IQR 0.730-0.836), while the median pAUC95 was 0.016 (IQR 0.004-0.021) and 0.023 (IQR 0.014-0.026) in the 2018 and 2020 workshops, respectively. Assays largely differed in AUC (IASP 2018 range 0.232-0.874; IASP 2020 range 0.379-0.924) and pAUC95 (IASP 2018 and IASP 2020 range 0-0.032). CONCLUSIONS/
interpretationAssay formats submitted to this study showed heterogeneous performance. Despite the high variability across laboratories, the in-house radiobinding assay (RBA) remains the gold standard for IAA measurement. However, novel non-radioactive IAA immunoassays showed a good performance and, if further improved, might be considered valid alternatives to RBAs.
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