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.
Genetic susceptibility and exposure to environmental factors are probable causes of type 1 diabetes, alternatively referred to as insulin-dependent diabetes mellitus (IDDM), a chronic autoimmune destruction of the insulin-secreting pancreatic beta cells. Autoantibodies against different antigens of the islet cells can be detected in the serum even before the onset of type 1 diabetes. This condition is believed to be completely asymptomatic until about 80 – 90% of the cells are destroyed, a process that may take years to complete, occurring regardless of age. Identification of these autoantibodies represent the most important markers to identify persons with increased risk to develop diabetes at a time when all metabolic tests available still show normal results.
ICA antibodies, which belong to the IgG subtype and are directed against a variety of islet cell antigens, are the first serological markers described for type 1 diabetes mellitus. AKLIDES® ICA is used in the detection of these autoantibodies via immunofluorescence using slides from the monkey pancreas.
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.
|Indication||Autoimmune diabetes mellitus type 1|
|Description||Indirect immunofluorescence assay for the determination of IgG antibodies in human serum against islet cell antigens|
|Format||Slides coated with cryostat tissue sections of monkey pancreas|
|Incubation time||60 min.|
|Sample volume||50 µL serum|
|No. of determinations||48 (12 x 4)|