Description:

The Diagnostic Automation Cardiolipin IgG, A, M, Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and qualitative determination of IgG, IgA, and IgM antibodies to cardiolipin in human sera. The assay is to be used to detect IgG, A, M antibodies in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of the anti-phospholipid syndrome in patients with autoimmune disease. This kit is for in vitro diagnostic use, a high complexity test.

In patients with Systemic Lupus Erythematosis (SLE), antibodies to cardiolipin (a negatively charged phospholipid) have been associated with both arterial and venous thrombosis, thrombocytopenia, and recurrent fetal loss. Patients with the anti-cardiolipin syndrome have one of the above clinical features and have antibodies to cardiolipin and/or a positive lupus anticoagulant test. The antibodies present to cardiolipin may be of the IgG, IgM and IgA isotypes. Cardiolipin testing for the various antibody isotypes aids in diagnosis of the anti- phospholipid syndrome in patients with SLE or lupus-like disorders. Several Enzyme-Linked Immunosorbent Assays have been developed and validated for detecting antibodies to cardiolipin.

The DAI Cardiolipin IgG, A, M test is an Enzyme-Linked Immunosorbent Assay for the detection and qualitative determination of IgA, IgM, IgG antibodies to cardiolipin antigens. Purified cardiolipin antigen is 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 antihuman IgG, A, M is added to each well. If antibody is present, it 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.