Laboratory criteria related to pregnancy morbidity

LABORATORY CRITERIA RELATED TO PREGNANCY MORBIDITY

Lupus anticoagulant (LA) present in plasma, on two or more occasions at least 12 weeks apart, detected according to the guidelines of the International Society on Thrombosis and Hemostasis.

  1. Anticardiolipin (aCL) antibody of IgG and/or IgM isotype in serum or plasma, present in medium or high titer, or > the 99th percentile, on two or more occasions, at least 12 weeks apart, measured by a standardized ELISA.
  2. Anti-b2glycoprotein-I antibody of IgG and/or IgM isotype in serum or plasma (in titer > the 99 percentile), present on two or more occasions, at least 12 weeks apart, measured by a standardized ELISA, according to recommended procedures.

Investigators are strongly advised to classify APS patients in studies into one of the following laboratory categories: I, more than one laboratory criteria (any combination); IIa, LA present alone; IIb, aCL antibody present alone; IIc, Anti-b2glycoprotein-I antibody present alone.

lassification of APS should be avoided if < 12 weeks or more than 5 years separate the positive aPL test and the clinical manifestations.

Coexisting inherited or acquired factors for thrombosis are not reason for excluding patients from APS trials. However, two subgroups of APS patients should be recognized according to: (a) the presence or (b) the absence of additional risk factor for thrombosis.

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