Comparison of positive rates between glutamic acid decarboxylase antibodies and ElisaRSR™ 3 Screen ICA™ in recently obtained sera from patients who had been previously diagnosed with slowly progressive type 1 diabetes

• Published in: Journal of diabetes investigation 2023-07, Vol.14 (7), p.856-863
• Main Authors: Takehana, Nobuaki, Fukui, Tomoyasu, Mori, Yusaku, Hiromura, Munenori, Terasaki, Michishige, Ohara, Makoto, Takada, Michiya, Tomoyasu, Masako, Ito, Yoshihisa, Kobayashi, Tetsuro, Yamagishi, Sho‐ichi
• Format: Article
• Language: English
• Subjects: 3 Screen ICA, Islet autoantibodies, Slowly progressive insulin‐dependent diabetes mellitus; Age; Antibodies; Autoantibodies; Body mass index; Diabetes; Diabetes mellitus (insulin dependent); Diabetes Mellitus, Type 1; Fasting; Females; Glucose; Glutamate Decarboxylase; Glutamic acid; Hemoglobin; Hormone replacement therapy; Humans; Insulin; Insulinoma; Islets of Langerhans; Laboratories; Latent Autoimmune Diabetes in Adults; Original; Patients; Peptides; Thyroid gland; Thyroiditis; Zinc transporter
• ISSN: 2040-1116; 2040-1124
• DOI: 10.1111/jdi.14016

Aims/Introduction This study aimed to compare the positivity rates of glutamic acid decarboxylase autoantibodies (GADA) and ElisaRSR™ 3 Screen ICA™ (3 Screen ICA), a newly developed assay for the simultaneous measurement of GADA, insulinoma‐associated antigen‐2 autoantibodies (IA‐2A), and zinc transporter 8 autoantibodies (ZnT8A), in recently obtained sera from patients who had been previously diagnosed with slowly progressive type 1 diabetes (SPIDDM). Materials and Methods We enrolled 53 patients with SPIDDM who were positive for GADA at the diagnosis and 98 non‐diabetic individuals, and investigated the diagnostic accuracy of the 3 Screen ICA (cutoff index ≥30 units) compared with that of GADA. In addition, we compared the clinical characteristics of patients with SPIDDM who were negative or positive on 3 Screen ICA. Results The positivity rates of 3 Screen ICA, GADA, IA‐2A, and ZnT8A were 88.7, 86.8, 24.5, and 13.2%, respectively. The respective sensitivity, specificity, and positive and negative predictive values for SPIDDM were 88.7, 100, 100, and 94.2% by 3 Screen ICA and 86.8, 100, 100.0, and 93.3% by GADA. There were no significant differences in age at onset, duration of diabetes, body mass index, glycated hemoglobin and C‐peptide levels, and the prevalence of autoimmune thyroiditis between patients with SPIDDM who were positive or negative on 3 Screen ICA. However, the prevalence of insulin users was significantly higher in those who were positive than in those who were negative on 3 Screen ICA. Conclusions Similar to GADA, 3 Screen ICA may be a useful diagnostic tool for detecting patients with SPIDDM. Incidence of GADA, IA‐2A, ZnT8A, and 3 Screen ICA positivity in SPIDDM patients.