The assay contributes to the diagnosis of antiphospholipid syndrome (APS). The clinical symptoms of APS alone are not sufficiently specific to make a definitive diagnosis. Laboratory tests thus play an important role in the diagnosis of the disease. In patients with APS, autoantibodies are formed that bind to phospholipids like cardiolipin or to phospholipid-binding proteins like beta-2-glycoprotein.
Detection of these autoantibodies is an integral part of the classification criteria issued by the International Society on Thrombosis and Hemostasis.
Beta-2-glycoprotein I is a 50 KD protein cofactor required by anti-cardiolipin antibodies (ACA) to bind to cardiolipin and other phospholipid molecules.
Anti-cardiolipin antibodies (ACA) have been associated with spontaneous arterial and venous thromboses occurring in patients with systemic lupus erythematosus and the anti-phospholipid antibody syndrome (APS); however not all ACA detected in the laboratory have this association. Some ACA are cross-reactive with anti-bacterial antibodies and others with anti-double-stranded DNA antibodies; therefore they are not highly specific for APS.
Beta-2-GPI antibodies are associated with the occurrence of arterial or venous thrombosis, as well as with recurring miscarriage. Beta-2-GPI antibodies are considered to have a higher specificity than cardiolipin antibodies for the detection of APS; they can be detected even when the cardiolipin test result is negative.
Investigations have shown that anti-B2-GPI antibodies are more (but not 100%) specific in identifying patients with "pathogenic" ACA associated with the antiphospholipid syndrome.
Both anti-B2GPI IgG and IgM testing are recommended for use in conjunction with traditionally used ACA and lupus anticoagulant tests but should not replace these assays because they are more sensitive.
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