Unique Accuracy in APS Diagnostics.
Antiphospholipid syndrome (APS) is a systemic autoimmune disease characterized by recurrent thrombosis, pregnancy morbidity, and a variety of other non-thrombotic manifestations. Patients are characterized by persistent antibodies against phospholipids and/or phospholipid-binding plasma proteins, which are responsible for the hypercoagulability of the blood. The classical APS criteria are based on the presence of lupus anticoagulant (LA), anticardiolipin (aCL), and anti-β2 glycoprotein I (anti-β2GPI) antibodies combined with clinical events such as thrombosis or pregnancy complications. Non-criteria APS antibodies, including anti-phosphatidylserine/prothrombin (aPS/PT) and anti-annexin V, are increasingly recognized for identifying patients with APS manifestations not captured by the traditional criteria.
Antiphospholipid syndrome (APS) is a systemic autoimmune disorder occurring worldwide, with an estimated prevalence of 40–60 per 100,000 individuals. Women are affected more frequently than men.
Whereas primary antiphospholipid syndrome (PAPS) occurs independently from other diseases, the more common secondary antiphospholipid syndrome (SAPS) is frequently related to other autoimmune diseases such as Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA). APS is characterized by the presence of antiphospholipid antibodies, which increase the risk of thrombosis and pregnancy complications.
In addition to classical criteria, non-criteria APS manifestations—including thrombocytopenia, heart valve disease, and neurological symptoms—are increasingly recognized. Non-criteria APS can also be associated with antibodies such as anti-phosphatidylserine, anti-prothrombin, anti-annexin V, and other emerging markers that help identify patients at risk.
Antiphospholipid syndrome can lead to serious consequences, including recurrent blood clots, pregnancy loss, organ damage, and long-term disability if not properly managed.
is the estimated prevalence of APS in the general population
is the women-men affected ratio
of recurrent pregnancy losses are related to APS
The diagnosis of APS is based on the clinical symptoms and confirmed by laboratory methods. Laboratory confirmation of APS is generally performed by the determination of antibodies against phospholipids and phospholipid binding proteins. Although a range of different test systems based on various methods has been made available, the use of standardized ELISA-based immunoassays is recommended in the latest ACR / EULAR APS classification criteria 2023.
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Any assay, any sample, any time!
a) Barbhaiya et al. (2023) 2023 ACR/EULAR antiphospholipid syndrome classification criteria. Ann. Rheum. Dis. 82, 1258.
b) Volkov et al. (2020) Profiles of criteria and non-criteria anti-phospholipid autoantibodies are associated with clinical phenotypes of the antiphospholipid syndrome. Auto. Immun. Highlights. 11, 8.
c) Devreese et al. (2014) Testing for antiphospholipid antibodies with solid phase assays: guidance from the SSC of the ISTH. J. Thromb. Haemost. 12, 792.
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