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Updated: Nov 13, 2025

Electrochemiluminescence Assays for Human Islet Autoantibodies
Published on: March 23, 2018
Autoantibody-Negative Type 1 Diabetes: A Neglected Subtype
Shivani K Patel1, Cindy S Ma2, Spiros Fourlanos3
1Diabetes and Metabolism, Garvan Institute of Medical Research, Sydney, NSW, Australia; Department of Diabetes and Endocrinology, St. Vincent's Hospital, Sydney, NSW, Australia; St. Vincent's Clinical School, Faculty of Medicine, UNSW Sydney, Sydney, NSW, Australia.
Abstract:
Up to 15% of individuals with a clinical phenotype of type 1 diabetes (T1D) do not have evidence of seropositivity for pancreatic islet autoantibodies. On this basis, they are classified as nonimmune or idiopathic, and remain an understudied population, as they are excluded from T1D immunomodulatory trials. Our limited understanding of the disease aetiopathogenesis in autoantibody-negative T1D hinders our ability to improve diagnostic pathways and discover novel therapeutic agents; particularly as we progress towards an era of precision medicine. This review summarises the current understanding and challenges in studying autoantibody-negative T1D. We review the literature regarding T1D classification, and the role of autoimmunity and defects in the immunogenic pathway that may distinguish autoantibody-positive and -negative T1D.
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