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Wyatt, R.C.* ; Brigatti, C.* ; Grace, S.L.* ; Williams, C.L.* ; Marzinotto, I.* ; Gillard, B.T.* ; Bazzigaluppi, E.* ; Shoemark, D.* ; Chandler, M.A.* ; Achenbach, P. ; Piemonti, L.* ; Gillespie, K.M.* ; Lampasona, V.* ; Williams, A.J.K.* ; Long, A.E.*

Improved prediction of symptomatic type 1 diabetes using a luciferase-based assay to measure (pro)insulin autoantibodies.

Diabetic Med.:e70277 (2026)
Verlagsversion DOI PMC
Open Access Hybrid
Creative Commons Lizenzvertrag
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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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Schlagwörter 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
Zeitschrift Diabetic Medicine
Quellenangaben Band: , Heft: , Seiten: , Artikelnummer: e70277 Supplement: ,
Verlag Wiley
Verlagsort 111 River St, Hoboken 07030-5774, Nj Usa
Begutachtungsstatus Peer reviewed
Institut(e) Institute of Diabetes Research (IDF)
Förderungen University of Bristol
Leona M. and Harry B. Helmsley Charitable Trust
Diabetes UK
JDRF