2050, 2150 – CentAK^® anti-IA₂ M

Highlights

• Use of recombinant human protein tyrosine phosphatase (IA2)
• Quantitative determination of the antibody activity
• Results expressed in U/mL
• High diagnostic sensitivity and specificity
• High precision within the measurement range
• CE marked

Intended Use

The CentAK^® anti-IA₂ M is a quantitative immunoassay for the determination of antibodies against protein tyrosine phosphatase (IA₂) in human serum. The CentAK^® anti-IA₂ M is intended as an aid in the diagnosis of autoimmune diabetes mellitus type 1 in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Diabetes mellitus type 1 is a chronic autoimmune disease in which the immune system destroys the insulin-producing beta cells of the islets of Langerhans in the pancreas. As a result, insulin production decreases, leading to persistently elevated blood glucose levels. Genetic predisposition and viral infections contribute to disease development; however, the exact pathogenic mechanisms remain incompletely understood.

Autoantibody Profiles in Type 1 Diabetes

Islet cell antibodies (ICA) drive the immune-mediated destruction of pancreatic beta cells. These antibodies target several key islet antigens, including glutamic acid decarboxylase (GAD65), protein tyrosine phosphatase (insulinoma-associated antigen 2, IA2), zinc transporter 8 (ZnT8), and insulin. Clinicians detect islet cell antibodies in 70–80% of patients with diabetes mellitus. Importantly, these antibodies often appear months to years before blood glucose levels rise. Therefore, they serve as valuable prognostic markers for identifying individuals at increased risk of developing type 1 diabetes. Consequently, clinicians regard the combined detection of antibodies against GAD65, IA2, ZnT8, and insulin as a key approach for diagnosing type 1 diabetes at disease onset.

Clinical Significance of IA2 Antibodies

Protein tyrosine phosphatase (insulinoma-associated antigen 2, IA2) localizes to the granules of pancreatic beta cells. Clinicians detect antibodies against IA2 in most patients with type 1 diabetes mellitus and in many individuals during the prediabetic phase. Moreover, the presence of IA2 antibodies correlates with a more rapid progression of the disease.

Publications

• Dinoi et al., (2025) Efficacy and safety of once-weekly semaglutide monotherapy in a young subject with Prader-Willi syndrome, obesity, and type 2 diabetes: a case report