Anti-Cardiolipin IgG / IgM ELISA is a test system for the quantitative measurement of IgG and IgM class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only. Highly purified cardiolipin is coated on microwells saturated with beta-2-glycoprotein I. 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 measuredphotometrically at 450 nm. Anti-phospholipid syndrome (APS, Hughes Syndrome) is a systemic autoimmune disease that causes thromboses, recurrent miscarriage, and intrauterine foetal death. Clinical symptoms are accompanied by the occurrence of specific autoantibodies that are detectable in the blood of patients with APS. These antibodies bind to phospholipids like cardiolipin, or phospholipid-binding proteins like beta-2-glycoprotein I.