3506 – Medizym® anti-IA2 M
The Medizym® anti-IA2 M is a quantitative immunoassay for the determination of antibodies against Protein Tyrosine Phosphatase (IA2) in human serum. The Medizym® anti-IA2 M is intended as an aid in the diagnosis of diabetes mellitus Type I in conjunction with other clinical and laboratory findings.
Type 1 diabetes mellitus, also called insulin-dependent diabetes mellitus, is a chronic autoimmune disease caused by the selective destruction of the insulin-producing pancreatic beta cells. In this process, autoantibodies are formed against the substances and structures localised inside the beta cell, which indicate the cell damage. These autoantibodies are the most important markers for detecting individuals at increased risk of diabetes at a time when all available metabolic tests still show normal results. Islet cell antigen IA2, a member of the protein tyrosine phosphatase family, is localised in the dense granules of pancreatic beta cells and is the second defined recombinant islet cell antigen. IA2 autoantibodies are present in the majority of individuals with new-onset type 1 diabetes and in individuals in the prediabetic phase of the disease. The occurrence of autoantibodies to IA2 appears to be correlated with the rapid progression of type 1 diabetes. Autoantibodies against IA2 occur in 50-70% of cases in newly manifested type 1 diabetes. Together with the determination of other autoantibodies, the diagnostic sensitivity and specificity for the prediction of type 1 diabetes is significantly increased.
The ELISA (Enzyme Linked Immunosorbent Assay) is an immunoassay for the determination of specific antibodies. The strips of the microtiter plate are coated with test-specific antigens. If antibodies are present in the patient’s sample, they bind to the antigens. A second biotinylated antigen binds the immobilized fixed antibody. The assay utilizes the ability of antibodies to act bivalently with immobilized and soluble antigens. Streptavidin conjugated with the enzyme peroxidase detects the generated immune complex. A colorless substrate is converted into the colored product by the peroxidase. The signal intensity of the reaction product is proportional to the antibody activity in the sample. After stopping the signal intensity of the reaction product is measured photometrically.
The immunoassay is designed for manual professional in vitro diagnostic use.
|Title||Medizym® anti-IA2 M|
|Indication||Diabetes mellitus Type I|
|Description||Enzyme immunoassay for the quantitative determination of antibodies against Protein Tyrosine Phosphatase (IA2) in human serum|
|Format||Microtiter plate coated with human recombinant Protein Tyrosine Phosphatase (IA2)|
|Total incubation time||160 min.|
|Sample volume||50 µL serum|
|No. of determinations||96 (90 x 1) + 5 x Calibrators and 1 x Control|