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 immunoassay 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 predispositions and viral infections are considered risk factors, but the exact causes have not yet been fully clarified.

The destruction of the insulin-producing beta cells of the pancreas is based on the presence of islet cell antibodies (ICA), which are directed against different antigens of the pancreatic islet cells, such as glutamic acid decarboxylase (GAD65), tyrosine phosphatase (insulinoma-associated antigen 2, IA2), the zinc transporter 8 (ZnT8) and against insulin. Islet cell antibodies (ICA) can be detected in 70 – 80 % of patients with diabetes mellitus. The different antibodies usually appear months to years before the occurrence of elevated blood sugar levels and are therefore also considered important prognostic markers to identify patients with an increased risk of developing diabetes mellitus type 1. The combined detection of antibodies against GAD65, IA2, ZnT8 and insulin is considered an important method for diagnosing diabetes mellitus type 1 at the onset of the disease.

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.