3806 – Medizym^® IAA

Highlights

• Use of recombinant human insulin
• Ready-to-use (exception: wash buffer), color- and barcoded reagents
• Quality assured handling in routine laboratories
• Incubation at room temperature
• Quantitative determination of IgG antibodies
• Calibrated with an internal reference sample
• Results expressed in U/mL
• Excellent diagnostic sensitivity and specificity
• High precision within the measurement range
• CE marked
• Automatable

Intended Purpose

The Medizym^® IAA is a quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of IgG antibodies against insulin (IAA) in human serum. The Medizym^® IAA is intended as an aid in the diagnosis of 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 insulin-producing beta cells of the islets of Langerhans in the pancreas are destroyed. The consequence of this destruction is a reduced insulin production, which results in high blood sugar levels as diabetes mellitus. Genetic predisposition and viral infections may increase the risk of the disease, but researchers have not yet fully clarified its exact causes.

Islet cell antibodies (ICA) drive the destruction of insulin-producing pancreatic beta cells. These antibodies target several antigens of the islet cells, including glutamic acid decarboxylase (GAD65), tyrosine phosphatase (IA2), zinc transporter 8 (ZnT8), and insulin. Clinicians detect ICAs in 70–80% of patients with diabetes mellitus. These autoantibodies often appear months to years before blood glucose levels rise and therefore serve as important prognostic markers for identifying individuals at increased risk of developing type 1 diabetes. Combined testing for antibodies against GAD65, IA2, ZnT8, and insulin plays a crucial role in diagnosing 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. These antibodies occur particularly frequently in children and adolescents who have not yet received insulin therapy.