T1Dにおけるインスリン自己抗体のリスク識別：新規ブリッジングELISAを用いて

In global type 1 diabetes (T1D) population screening studies, there is an urgent need for a highly sensitive and specific insulin autoantibody (IAA) assay that can be implemented across multiple laboratories. This study aimed to develop and characterize a novel ELISA-based platform for IAA detection. We established a new bridging ELISA for IAA and validated it in cohorts of patients with stage 3 T1D, children positive for with multiple and single islet antibodies, and control children negative for islet autoantibodies. The bridging ELISA-IAA assay demonstrates excellent sensitivity and specificity, preferentially identifies high-risk individuals, and offers a practical, scalable solution for T1D population screening and clinical diagnosis across laboratories.