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Antibodies to β2‐glycoprotein I—a specific marker for the antiphospholipid syndrome

The antiphospholipid syndrome is a disorder characterized by recurrent thrombosis and the presence of antibodies specific to phospholipids. However, the diagnosis of this syndrome is hampered by the lack of a specific laboratory test. In this study an ELISA for the measurement of antibodies to solid‐phase β2‐glycoprotein I (β2‐GPI) was established and compared with anticardiolipin antibodies for diagnosis of antiphospholipid syndrome. Significantly elevated levels of antibodies to β2‐GPI were found in all patients with definite antiphospholipid syndrome (median  =  91 AU). Marginally elevated levels of antibodies to β2‐GPI were observed in 5% of patients with systemic lupus erythematosus (SLE; median  =  4 AU), 1% with stroke (median  =  3 AU), 13% with infectious mononucleosis (median  =  3 AU), 10% with HIV infection (median  =  3 AU) and 8% with VDRL false‐positive serology for syphilis (median  =  4 AU), but not in patients with rheumatoid factor, syphilis or carotid artery stenosis. In contrast, significantly raised levels of anticardiolipin antibodies were observed in 100% of patients with definite antiphospholipid syndrome, 30% with SLE, 88% with HIV infection, 94% with syphilis, 62% with infectious mononucleosis, 9% with rheumatoid factor‐positive sera, 74% VDRL false‐positive serology for syphilis, 47% with stroke and 0% with carotid artery stenosis. This solid‐phase assay for antibodies to β2‐GPI is highly specific for the antiphospholipid syndrome and represents an advance in the laboratory diagnosis of this disorder.