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Improved prediction of symptomatic type 1 diabetes using a luciferase-based assay to measure (pro)insulin autoantibodies.
Diabetic Med.:e70277 (2026)
INTRODUCTION: Insulin autoantibodies (IAA) are key predictors of type 1 diabetes, particularly in young children. Micro-radiobinding assays (RBA) are the gold standard for IAA measurement but have limitations. We assessed whether a luciferase immunoprecipitation system (LIPS) assay improved diabetes risk assessment. METHODS: To validate LIPS compared with RBA, samples from people with new-onset type 1 diabetes (n = 150) and first-degree relatives (FDRs) (n = 619), of whom 91 had developed diabetes during follow-up, were used. This cross-sectional observational data was analysed using the area under the receiver operator characteristic curve and cox-proportional hazard models. RESULTS: In new-onset diabetes, RBA and LIPS showed 88% agreement in IAA status. Positive IAA LIPS was more common in 89 FDRs with high-moderate affinity IAA (61%) compared with 22 FDRs with low-affinity IAA (18%) (p < 0.001). In FDRs positive for multiple other islet autoantibodies, 20-year diabetes risk was 80% for those positive compared with 30% for those negative for IAA by LIPS (p = 0.013). IAA LIPS added to diabetes risk independently of status/level of IAA by RBA, other autoantibodies and sampling age (p < 0.001). CONCLUSION: The IAA LIPS low-blood-volume, high-throughput technique identifies more individuals with the highest risk of diabetes. The ability to identify high-affinity IAA makes LIPS an ideal method for future clinical trials and population screening strategies to predict the risk of diabetes.
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Publication type
Article: Journal article
Document type
Scientific Article
Keywords
Antibody Affinity ; Autoimmunity ; Diabetes Mellitus ; Insulin Antibodies ; Luciferase ; Predictive Value Of Tests ; Type 1; Children; Risk; Relatives
ISSN (print) / ISBN
0742-3071
e-ISSN
1464-5491
Journal
Diabetic Medicine
Quellenangaben
Article Number: e70277
Publisher
Wiley
Publishing Place
111 River St, Hoboken 07030-5774, Nj Usa
Reviewing status
Peer reviewed
Institute(s)
Institute of Diabetes Research (IDF)
Grants
University of Bristol
Leona M. and Harry B. Helmsley Charitable Trust
Diabetes UK
JDRF
Leona M. and Harry B. Helmsley Charitable Trust
Diabetes UK
JDRF