Anticardiolipin and Anti-Beta-2 Glycoprotein 1 AntibodiesĪ strong correlation has been observed between aCL and anti-β 2GP1 antibody concentrations, but testing for both antibody types in conjunction with LA is still recommended. Positivity for LA alone, apart from the other aPLs, has a strong association with thrombotic events and adverse outcomes in pregnancy. Lupus AnticoagulantĪt least two phospholipid-dependent clotting assays with appropriate reflexive steps to satisfy detection guidelines, based on different principles (such as activated partial thromboplastin time and dilute Russell viper venom testing ), should be performed to identify LA.
If positive, laboratory tests should be repeated at least 12 weeks later to confirm persistent positivity. Triple positivity also indicates a high risk of thrombotic recurrence in patients with APS. Positivity for all three (LA as well as aCL and β 2GP1 antibodies) is strongly associated with thromboembolism and pregnancy-related morbidity. The combination of the three tests reduces the risk of false-negative findings and is important for estimating disease risk. Laboratory Testing Diagnosis First-Line or Criteria TestsĬurrent recommendations for first-line testing in APS include lupus anticoagulant (LA) clot-based assays and tests for aCL IgG and IgM antibodies and anti-β 2GP1 IgG and IgM antibodies (available together in an APS panel test in some labs). Sources: Miyakis, 2006 Bertolaccini, 2014 Devreese, 2018 LA: detected in plasma according to ISTH guidelinesĪCL antibodies: IgG and/or IgM isotype present in a medium or high titer (>40 GPL or MPL units or >99th percentile), as measured by standardized ELISAĪnti-β 2GP1 antibodies: IgG and/or IgM isotype in high titer (>99th percentile), measured by standardized ELISAĪAt least 1 clinical and 1 laboratory criterion must be met.ĪCL, anticardiolipin anti-β 2GP1, anti-beta-2 glycoprotein 1 ELISA, enzyme-linked immunosorbent assay GPL, immunoglobulin G (IgG) phospholipid antibody ISTH, International Society on Thrombosis and Haemostasis MPL, IgM phospholipid antibody Positive for LA or aCL or anti-β 2GP1 antibodies (according to specified criteria) on ≥2 occasions at least 12 weeks apart ≥3 unexplained, consecutive, spontaneous abortions before the 10th week of gestation, with maternal anatomic or hormonal abnormalities and paternal and maternal chromosomal causes excluded ≥1 premature births of a morphologically normal neonate before the 34th week of gestation due to preeclampsia, eclampsia, or placental insufficiency ≥1 unexplained deaths of a morphologically normal fetus after the 10th week of gestation ≥1 clinical episodes of arterial, venous, or small-vessel thrombosis in any tissue or organ, validated by imaging studies or histopathology Criteria for Diagnosis Current Classification Criteria for APS a Clinical Criteria Testing for APS is appropriate for individuals with indications of APS, such as venous or arterial thromboses or pregnancy-related morbidity (see Quick Answers for Clinicians for complete list of indications).
Testing should be repeated before surgery, transplantation, pregnancy, and use of treatments containing estrogen, or if the patient presents with a new vascular, neurologic, or obstetric event. Patients with systemic lupus erythematosus (SLE) should have a baseline test performed for antiphospholipid syndrome (APS). Testing should also be considered for patients with certain obstetric manifestations, such as one or more unexplained fetal losses after week 10 of gestation, unexplained severe intrauterine growth restriction, severe or early preeclampsia, or three or more spontaneous miscarriages before week 10 of gestation (after exclusion of maternal anatomic or hormonal abnormalities or paternal/maternal chromosomal causes). Individuals with arterial thrombosis or unprovoked venous thrombosis before 50 years of age, recurrent thrombosis or thrombosis at an unusual site, or thrombotic microangiopathy of unknown etiology should be screened for antibodies associated with antiphospholipid syndrome.
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