4010 – ANAscreen
The ANAscreen is a semi-quantitative immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens in human serum. The ANAscreen is intended as an aid in the diagnosis of systemic autoimmune disorders in conjunction with other clinical and laboratory findings.
The appearance of autoantibodies directed against components of the cell nucleus is a characteristic feature of systemic autoimmune diseases, especially; systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA) and dermatomyositis. The detection of autoantibodies in patient sample is well established and plays an essential role in the diagnosis of systemic autoimmune diseases.
The use of antigenic combination of complete HeLa nuclei with recombinant proteins and purified native antigens offers a very sensitive screening approach to detect antinuclear antibodies (ANA) directed against nuclear and cytoplasmic antigens. ANAscreen allows the detection of total autoantibodies in one sample as a summary or profile parameter in the diagnosis of systemic autoimmune disorders.
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 secondary antibody conjugated with the enzyme peroxidase detects the generated immune complex. A colorless substrate is converted into the colored product. 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.
|Indication||Systemic autoimmune diseases|
|Description||Enzyme immunoassay for the semi-quantitative determination of IgG antibodies against nuclear and cytoplasmic antigens in human serum|
|Format||Microtiter plate coated with HeLa nuclei and enriched with recombinant and native antigens|
|Total incubation time||105 min.|
|Sample volume||10 µL serum|
|No. of determinations||96 (93 x 1) + 1 x Calibrators + 2 x Controls|