4129 – AKLIDES® ICA

The AKLIDES® ICA is an immunofluorescence assay (IFA) for the qualitative determination of IgG antibodies in human serum against islet cell antigens (ICA) on monkey pancreas sections. The AKLIDES® ICA is intended as an aid in the diagnosis of autoimmune diabetes mellitus type 1 in conjunction with other clinical and laboratory findings.

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.

The IFA (indirect immunofluorescence assay) is an immuno-assay for the determination of specific antibodies. Tissue sections or cells containing the antigen of interest are immobilized on slides. If specific antibodies are present in the patient´s sample, they bind to the antigen in the tissue. A secondary antibody conjugated with fluorescein-isothiocyanat (FITC) detects the generated immune complex. The slides are examined using a fluorescence microscope. A specific fluorescent staining pattern demonstrates the presence of specific antibodies in the patient´s sample.

The immunoassay is designed for manual processing and automated imaging using the AKLIDES® or akiron® system.

Worldwide first and fully automated system, AKLIDES® digital fluorescence microscope is used for the standardized imaging and data processing in immunofluorescence tests on glass slides. Controlled by the AKLIDES® Software, the AKLIDES® system has the ability to produce valid standardized analyses and to document immunofluorescence assays electronically to augment daily laboratory routine in the diagnosis of autoimmune diseases.

The immunoassay is designed for professional in vitro diagnostic use.