ANA-8-Screen ELISA is a test system for the qualitative measurement of antinuclear antibodies (ANAs) SS-A (52 and 60 kDa), SS-B, RNP-70, Sm, RNP/Sm, Scl-70, Centromere B and Jo-1 in human serum or plasma. This product is intended for professional in vitro diagnostic use only. The test is used for screening of patients with suspected autoimmune connective tissue diseases, e.g. systemic lupus erythematosus, mixed connective tissue disease, Sjoegren’s syndrome, scleroderma, and polymyositis/dermatomyositis. Evaluation of a test result should always take into account all clinical and laboratory diagnostic findings. A mixture of purified antigens SS-A 60, SS-A 52, SS-B, RNP-70, Sm, RNP/Sm, Scl-70, Centromere B and Jo-1 is coated on to microwells.
The determination is based on an indirect enzyme linked immune reaction with the following steps: Specific antibodies in the patient sample bind to the antigen coated on the surface of the reaction wells. After incubation, a washing step removes unbound and unspecifically bound serum or plasma components. Subsequently added enzyme conjugate binds to the immobilized antibody-antigen-complexes. After incubation, a second washing step removes unbound enzyme conjugate. After addition of substrate solution the bound enzyme conjugate hydrolyses the substrate forming a blue coloured product. Addition of an acid stops the reaction generating a yellow end-product. The intensity of the yellow colour correlates with the concentration of the antibody-antigen-complex and can be measured photometrically at 450 nm.