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.

Islet cell antibodies (ICA) attack the insulin-producing beta cells of the pancreas by targeting antigens such as glutamic acid decarboxylase (GAD65), tyrosine phosphatase (insulinoma-associated antigen 2, IA2), zinc transporter 8 (ZnT8), and insulin. Clinicians detect ICA in 70–80% of patients with diabetes mellitus. These antibodies often appear months to years before blood sugar levels rise, making them important prognostic markers for identifying individuals at increased risk of developing type 1 diabetes. By measuring antibodies against GAD65, IA2, ZnT8, and insulin together, clinicians can effectively diagnose type 1 diabetes at disease onset.

Publications

• Bogdanos et al., (2012) Pancreatic-specific autoantibodies to glycoprotein 2 mirror disease location and behaviour in younger patients with Crohn's disease