2035 – CentAK^® IAA M

Highlights

• Use of recombinant human insulin
• 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^® IAA M is a quantitative radioimmunoassay for the determination of antibodies against insulin (IAA) in human serum. The CentAK^® IAA 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 occurs when the immune system destroys insulin-producing beta cells in the pancreas.. 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 are considered risk factors, but the exact causes have not yet been fully clarified.

Islet cell antibodies (ICA) drive the destruction of insulin-producing beta cells in the pancreas. These antibodies target antigens such as GAD65, IA2, ZnT8, and insulin. Clinicians detect ICA in 70–80% of patients with type 1 diabetes. The antibodies often appear months or years before high blood sugar develops, making them key prognostic markers. Combined detection of GAD65, IA2, ZnT8, and insulin antibodies helps diagnose type 1 diabetes at disease onset.

The appearance of antibodies against insulin (IAA) is another indication of progressive destruction of the pancreas in patients with diabetes mellitus type 1. Their prevalence is particularly increased in children and adolescents who have not yet been treated with insulin.