Efficacy of a new enzyme-linked immunosorbent assay system for three islet cell autoantibodies in Japanese patients with acute-onset type 1 diabetes

• Published in: Endocrine Journal p. EJ22-0146
• Main Authors: Fukui, Tomoyasu, Takehana, Nobuaki, Mori, Yusaku, Hiromura, Munenori, Terasaki, Michishige, Kushima, Hideki, Takada, Michiya, Tomoyasu, Masako, Sato, Nobuko, Hayashi, Toshiyuki, Ohara, Makoto, Kikuchi, Tsuyoshi, Ito, Yoshihisa, Kobayashi, Tetsuro, Yamagishi, Sho-ichi
• Format: Journal Article
• Language: English
• Published: The Japan Endocrine Society 2022
• Subjects: Biomarker; Islet autoantibodies; Type 1 diabetes
• ISSN: 0918-8959; 1348-4540
• DOI: 10.1507/endocrj.EJ22-0146

To evaluate the clinical efficacy of a new enzyme-linked immunosorbent assay (ELISA) system for simultaneously detecting three islet cell autoantibodies against glutamic acid decarboxylase (GADA), insulinoma-associated antigen-2 (IA-2A), and zinc transporter 8 (ZnT8A) (3 Screen ICA ELISA) in Japanese patients with acute-onset type 1 diabetes (T1D). In addition, clinical factors affecting the 3 Screen ICA ELISA index were investigated. We compared the positivity values of 3 Screen ICA ELISA with that of each autoantibody alone in 97 patients with acute-onset T1D (mean age 48.7 years, 49% male) and 100 non-diabetic subjects (mean age 47.0 years, 50% male). Serum thyroid stimulating hormone receptor antibody, thyroid peroxidase antibody (TPOAb) and thyroglobulin autoantibody levels were also evaluated. The cut-off value of the 3 Screen ICA ELISA was determined based on the 97th percentile of 100 non-diabetic controls (threshold for positivity, ≥14 index). The mean age of disease onset and duration of diabetes were 34.2 years and 14.5 years, respectively. Among all T1D patients, the positivity of 3 Screen ICA ELISA was 71.1%, while that of GADA, IA-2A, and ZnT8A were 59.8%, 25.8%, and 25.8%, respectively. The median 3 Screen ICA index was 121.9 (8.7–468.2) and was associated with titers of each autoantibody, most so with GADA, and was significantly higher in TPOAb-positive patients than in TPOAb-negative patients. Our findings suggests that the 3 Screen ICA ELISA may be a time-saving diagnostic tool for evaluating islet autoantibodies in acute-onset T1D patients.