85848 – ICA IFA

Highlights

• Slides coated with tissue sections of monkey pancreas
• Sensitive detection of IgG antibodies against islet cells (ICA)
• Support for the diagnosis of autoimmune diabetes mellitus type 1
• Qualitative and semi-quantitative determination of IgG antibodies
• Ready-to-use reagents (exception: PBS buffer)
• Quality assured handling in routine laboratories
• Short incubation times (30 min / 30 min) at room temperature
• Consistent processing for the parallel use of multiple IF assays
• High diagnostic sensitivity and specificity
• CE marked

Intended Purpose

The ICA IFA is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum against islet cell antigens (ICA) on tissue sections of monkey pancreas. The ICA IFA is intended as an aid in the diagnosis of autoimmune diabetes mellitus type I 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) as well as 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.