Table 1.

Summary of the Sydney Consensus Statement on Investigational Classification Criteria for the APS.13 
 Antiphospholipid antibody syndrome (APS) is present if at least one of the clinical criteria and one of the laboratory criteria that follow are met.

Clinical criteria 
Vascular thromboses:

  1. One or more documented episodes of arterial, venous, or small vessel thrombosis—other than superficial venous thrombosis—in any tissue or organ. Thrombosis must be confirmed by objective validated criteria. For histopathologic confirmation, thrombosis should be present without significant evidence of inflammation in the vessel wall.

  2. Pregnancy morbidity

    • One or more unexplained deaths of a morphologically normal fetus at or beyond the 10th week of gestation, with normal fetal morphology documented by ultrasound or by direct examination of the fetus, or

    • One or more premature births of a morphologically normal neonate before the 34th week of gestation because of: (i) eclampsia or severe pre-eclampsia defined according to standard definitions, or (ii) recognized features of placental insufficiency, or

    • Three or more unexplained consecutive spontaneous abortions before the 10th week of gestation, with maternal anatomic or hormonal abnormalities and paternal and maternal chromosomal causes excluded.

 
In studies of populations of patients who have more than one type of pregnancy morbidity, investigators are strongly encouraged to stratify groups of subjects according to a, b, or c above. 
Laboratory criteria 

  1. Lupus anticoagulant (LAC) 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 Haemostasis (Scientific Subcommittee on LACs/phospholipid- dependent antibodies).41 

  2. Anticardiolipin antibody (aCL) of IgG and/or IgM isotype in serum or plasma, present in medium or high titer (i.e., > 40 GPL or MPL, or > the 99th percentile), on two or more occasions, at least 12 weeks apart, measured by a standardized ELISA.

  3. Anti-β 2 glycoprotein-I antibody of IgG and/or IgM isotype in serum or plasma (in titer >the 99th 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 categories: I, more than one laboratory criteria present (any combination); IIa, LAC present alone; IIb, aCL present alone; IIc, anti-β2GPI antibody present alone. 
Summarized from
Miyakis S, Lockshin MD, Atsumi T, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS).
J Thromb Haemost
.
2006
;
4
:
295
–306.
 
Clinical criteria 
Vascular thromboses:

  1. One or more documented episodes of arterial, venous, or small vessel thrombosis—other than superficial venous thrombosis—in any tissue or organ. Thrombosis must be confirmed by objective validated criteria. For histopathologic confirmation, thrombosis should be present without significant evidence of inflammation in the vessel wall.

  2. Pregnancy morbidity

    • One or more unexplained deaths of a morphologically normal fetus at or beyond the 10th week of gestation, with normal fetal morphology documented by ultrasound or by direct examination of the fetus, or

    • One or more premature births of a morphologically normal neonate before the 34th week of gestation because of: (i) eclampsia or severe pre-eclampsia defined according to standard definitions, or (ii) recognized features of placental insufficiency, or

    • Three or more unexplained consecutive spontaneous abortions before the 10th week of gestation, with maternal anatomic or hormonal abnormalities and paternal and maternal chromosomal causes excluded.

 
In studies of populations of patients who have more than one type of pregnancy morbidity, investigators are strongly encouraged to stratify groups of subjects according to a, b, or c above. 
Laboratory criteria 

  1. Lupus anticoagulant (LAC) 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 Haemostasis (Scientific Subcommittee on LACs/phospholipid- dependent antibodies).41 

  2. Anticardiolipin antibody (aCL) of IgG and/or IgM isotype in serum or plasma, present in medium or high titer (i.e., > 40 GPL or MPL, or > the 99th percentile), on two or more occasions, at least 12 weeks apart, measured by a standardized ELISA.

  3. Anti-β 2 glycoprotein-I antibody of IgG and/or IgM isotype in serum or plasma (in titer >the 99th 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 categories: I, more than one laboratory criteria present (any combination); IIa, LAC present alone; IIb, aCL present alone; IIc, anti-β2GPI antibody present alone. 
Summarized from
Miyakis S, Lockshin MD, Atsumi T, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS).
J Thromb Haemost
.
2006
;
4
:
295
–306.
 
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