Description

The Diagnostic Automation Cardiolipin IgA ELISA kit is intended for the detection and semi-quantitative determination of IgA antibodies to Cardiolipin in human sera or plasma. The assay is to be used to detect IgA antibodies in a single 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.

Anti-Cardiolipin auto antibodies (ACA) are frequently found in patients with systemic lupus erythematosus (SLE). They are also found in patients with other autoimmune diseases, as well as in some individuals with no apparent previous underlying diseases. Elevated levels of ACA have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. Anti-phospholipid syndrome has been used to describe patients who present these clinical manifestations, in association with ACA or lupus anticoagulant. ACA are found in the immunoglobulin classes IgG, IgM and IgA. The determination of IgM antibodies is a valuable indicator in the diagnosis of beginning autoimmune disease, whereas IgG antibodies will be found in progressive stages of manifested autoimmune disorders. ACA IgG shows a good correlation to the clinical status of the patient in thrombosis, thrombocytopenia, fetal loss, and some neurological disorders. ACA IgA is often associated with IgG antibodies. ACA IgA seems to have a greater validity in thrombosis and fetal loss. ELISA testing for ACA of various isotypes aids in diagnosis of Anti-phospholipid syndrome in patients with SLE and lupus-like disorders.

Purified Cardiolipin antigens are coated on the surface of microwells. Diluted patient serum or plasma, and calibrators, are added to the wells. The Anticardiolipin specific antibodies, if present, bind to the antigens. All unbound materials are washed away. After adding enzyme conjugate, it binds to the antibody-antigen complex. Excess enzyme conjugate is washed off, and TMB Chromogenic substrate is added. The enzyme conjugate catalytic reaction is stopped at a specific time. The intensity of the color generated is proportional to the amount of IgA specific antibodies in the sample. The results are read by a microwell reader, and compared in a parallel manner with calibrators.