4289 – ANA 12 LINE

The ANA 12 LINE is a qualitative line immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (dsDNA, nucleosome, Sm, ribosomes, histone, RNP, SS-A 60, SS-A 52, SS-B, Scl-70, CENP-B and Jo-1) in human serum. The ANA 12 LINE is intended as an aid in the diagnosis of systemic inflammatory rheumatic diseases in conjunction with other clinical and laboratory findings.

The appearance of autoantibodies directed against components of the cell nucleus are characteristic features 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, e.g. plasma and serum, is well established and plays an essential role in the diagnosis of systemic autoimmune diseases.

Line immunoassays are frequently used for the determination of specific antibodies directed against multiple antigens. The test strips are coated with various antigens in consistent intervals. If antibodies are present in the patient´s sample, they bind to the respective antigens. A secondary antibody conjugated with the enzyme peroxidase detects the generated immune complexes. A colorless substrate is converted into a colored, insoluble product. The signal intensity of the precipitated reaction product is proportional to the antibody activity in the sample..

The ANA 12 LINE is designed for manual professional in vitro diagnostic use.