Table 1.

Clinical and diagnostic laboratory criteria for the diagnosis of antiphospholipid antibody syndrome (the “Sapporo criteria”).1,2 

* Anti-β2-glycoprotein I antibodies (IgG and IgM) are currently not included in the laboratory criteria for diagnosis of antiphospholipid syndrome, although a recent consensus meeting at the 11th International Conference on Antiphospholipid Antibodies, held in Sydney, Australia, in 1994, has proposed that these antibodies be included in the list of diagnostic laboratory studies. 
† ISTH criteria for lupus anticoagulants includes: [1] prolongation of a phospholipid-dependent screening assay; [2] evidence of inhibitory activity with mixing studies; [3] evidence that the inhibitory activity is phospholipid-dependent; and [4] distinction of other coagulopathies.5  
Clinical criteria (one or more of the following clinical events must be present)

  • Vascular thrombosis.

    • One or more episodes of arterial, venous, or small vessel thrombosis, affecting any tissue or organ.

  • Pregnancy morbidity

    • Unexplained death of a morphologically normal fetus at or after the 10th week of gestation.

    • Premature birth of morphologically normal neonates at or before the 34th week of gestation, because of severe preeclampsia or eclampsia, or severe placental insufficiency.

    • Three of more unexplained consecutive spontaneous abortions before the 10th week of gestation.

 
Laboratory criteria (one or more of the following laboratory findings must be present)*

  • Anticardiolipin IgG or IgM antibodies present at moderate to high levels on 2 or more occasions separated by at least 6 weeks (minimally greater than 20 IgG or IgM units).6 

  • Lupus anticoagulant, diagnosed by the ISTH criteria,† detected in the blood on 2 or more occasions separated by at least 6 weeks.

 
* Anti-β2-glycoprotein I antibodies (IgG and IgM) are currently not included in the laboratory criteria for diagnosis of antiphospholipid syndrome, although a recent consensus meeting at the 11th International Conference on Antiphospholipid Antibodies, held in Sydney, Australia, in 1994, has proposed that these antibodies be included in the list of diagnostic laboratory studies. 
† ISTH criteria for lupus anticoagulants includes: [1] prolongation of a phospholipid-dependent screening assay; [2] evidence of inhibitory activity with mixing studies; [3] evidence that the inhibitory activity is phospholipid-dependent; and [4] distinction of other coagulopathies.5  
Clinical criteria (one or more of the following clinical events must be present)

  • Vascular thrombosis.

    • One or more episodes of arterial, venous, or small vessel thrombosis, affecting any tissue or organ.

  • Pregnancy morbidity

    • Unexplained death of a morphologically normal fetus at or after the 10th week of gestation.

    • Premature birth of morphologically normal neonates at or before the 34th week of gestation, because of severe preeclampsia or eclampsia, or severe placental insufficiency.

    • Three of more unexplained consecutive spontaneous abortions before the 10th week of gestation.

 
Laboratory criteria (one or more of the following laboratory findings must be present)*

  • Anticardiolipin IgG or IgM antibodies present at moderate to high levels on 2 or more occasions separated by at least 6 weeks (minimally greater than 20 IgG or IgM units).6 

  • Lupus anticoagulant, diagnosed by the ISTH criteria,† detected in the blood on 2 or more occasions separated by at least 6 weeks.

 
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