The DIASTAT™ Total anti-Cardiolipin test is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the combined detection of IgG, IgM and IgA autoantibodies specific for the phospholipid Cardiolipin in human serum or plasma (EDTA, citrate, heparin). It is intended to assess total anti-Cardiolipin autoantibody levels in patients where this information is useful in diagnosis, particularly as an aid in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders. A test result is not definitive in isolation. Autoantibody levels represent one parameter in a multicriterion diagnostic process.
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Reference report developed for the determination of IgG/IgM anti-cardiolipin antibodies by ELISA.
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