Description:

The Diagnostic Automation Scl-70 Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and semi-quantization of antibodies to Scl-70 in human sera. The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of autoimmune disease.

The DAI Scl-70 test is an Enzyme-Linked Immunosorbent Assay to detect IgG, IgA, and IgM antibodies to Scl-70 antigens. Purified Scl-70 antigens are attached to a solid phase microassay well. Diluted test sera are added to each well. If the antibodies are present that recognize the antigen, antigen-antibody complexes are formed. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG, IgA, IgM, is added to each well. If antibody is present the conjugate will bind to the antigen-antibody complexes. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period, the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

Precautions were taken in the manufacture of this product to protect the reagents from contamination and bacteriostatic agents have been added to the liquid reagents. Care should be exercised to protect the reagents in this kit from contamination. Do not use if evidence of microbial contamination or precipitation is present.