Criteria for the diagnosis of the antiphospholipid syndrome:
(1) at least 1 clinical criterion
(2) one of the four laboratory criteria
Clinical criteria:
(1) >= 1 vascular thrombosis in any artery, vein or small vessel confirmed by an objective criterion and in the absence of vasculitis
(2) >= 3 unexplained consecutive abortions before 10th week of gestation with normal maternal and paternal cytogenetics and normal maternal anatomy
(3) >= 1 unexplained fetal death after 10th week of gestation with normal fetal morphology
(4) >= 1 premature birth before 34th week of gestation because of eclampsia or severe pre-eclampsia
(5) >= 1 premature birth before 34th week of gestation with placental insufficiency
Laboratory criteria:
(1) lupus anticoagulant on >= 2 occasions >= 12 weeks apart
(2) IgG and/or IgM anticardiolipin antibody at moderate to high titers (> 40 GPL or MPL units) on >= 2 occasions >= 12 weeks apart
(3) IgG and/or IgM anti-beta-2-glycoprotein antibody on >= 2 occasions >= 12 weeks apart
(4) mixed (more than one of the above)
Additional constraints:
(1) The diagnosis should be avoided if there is a gap of > 5 years between the positive laboratory finding and clinical manifestations.
(2) The presence of risk factors for a thrombotic disorder or atherosclerotic disease should be recorded.
(3) The laboratory testing must be done in strict adherence to guidelines.
