2070, 2071 – CentAK^® anti-GAD₆₅ M

Highlights

• Use of recombinant human glutamic acid decarboxylase (GAD₆₅)
• 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 Purpose

The CentAK^® anti-GAD₆₅ M is a quantitative radioimmunoassay for the determination of antibodies against glutamic acid decarboxylase (GAD₆₅) in human serum. The CentAK^® anti-GAD₆₅ 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

Type 1 diabetes is a chronic autoimmune disease in which the pancreas’s insulin-producing beta cells are gradually destroyed. The consequence of this destruction is a reduced insulin production, which results in high blood sugar levels as diabetes mellitus. Genetic predispositions and viral infections may increase the risk, but researchers have not fully clarified the exact causes.

Role of Islet Cell Antibodies in Disease Development

Type 1 diabetes involves immune-mediated destruction of pancreatic beta cells. Islet cell antibodies (ICA) drive this process and target antigens such as glutamic acid decarboxylase (GAD65), protein tyrosine phosphatase (IA2), zinc transporter 8 (ZnT8), and insulin. Clinicians detect ICAs in 70–80% of patients, often months to years before hyperglycemia develops. Therefore, these antibodies serve as important prognostic markers for identifying individuals at risk. Consequently, the combined detection of GAD65, IA2, ZnT8, and insulin antibodies supports diagnosis at disease onset.

Diagnostic Value of GAD65 Antibodies

Glutamic acid decarboxylase (GAD) catalyzes the synthesis of the neurotransmitter gamma-aminobutyric acid (GABA) in the brain and in pancreatic beta cells. The CentAK® anti-GAD65 M quantitatively detects antibodies against GAD65 in human serum and supports the diagnosis of type 1 diabetes. The assay is CE marked and delivers high diagnostic sensitivity and precision.

Publications

• Verdú et al., (2025) Clinical relevance of the Maglumi for anti-GAD65 in T1DM & neurological disorders
• 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