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  • Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sample (e.g., serum) to determine antibodies against cardiolipin (i.e., anti-CL antibodies), an anionic phospholipid present in mitochondrial and bacterial membranes. Increased levels of anti-CL antibodies are found in some patients in a large spectrum of autoimmune diseases, including connective tissue diseases, rheumatoid arthritis, and systemic lupus erythematosus. These antibodies (particularly, some specific monoclonal antibodies) are also present in the serum of patients with the antiphospholipid syndrome; they are associated with increased risks of thrombosis and coronary and cerebral ischemic disorders.
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