Enhancing diagnostic accuracy for antiphospholipid syndrome (APS)
Improve the confidence of APS detection with EliA™ antiphospholipid syndrome assays in your lab.
What is antiphospholipid syndrome?
Antiphospholipid syndrome is an autoimmune disorder characterized by the presence of antiphospholipid antibodies (aPL), which increases the risk of blood clots in veins and arteries. This condition can lead to severe health complications including miscarriages, stroke, and deep vein thrombosis.
APS is defined by:1
Clinical features of recurrent thrombosis or miscarriage
Thrombotic events often involving multiple organs
Persistent positive tests for aPL
What assays are part of the EliA APS portfolio?
Accurate and timely testing for APS is critical for improving patient outcomes. An APS diagnosis requires clinical and laboratory criteria, including the detection of specific aPL antibodies like anticardiolipin (aCL) and anti-β2 glycoprotein I (aβ2GPI).2
Our EliA™ APS portfolio includes:
First line testing
Recommended in the 2023/ACREULAR classification criteria for APS3
EliA™ Cardiolipin IgG
EliA™ Cardiolipin IgM
EliA™ ß2GPI* IgG
EliA™ ß2GPI* IgM
Second line testing
Recommended when results of all other tests are negative and APS is still suspected4
EliA™ Cardiolipin IgA
EliA™ ß2GPI* IgA
*Full product names are EliATM β2-Glycoprotein I IgG, EliATM β2-Glycoprotein I IgM, and EliATM β2-Glycoprotein I IgA
EliA tests offer relevant identifying autoantibody tests for APS classification criteria. And when combined with other clinical findings, they can aid in an accurate diagnosis.5-12
Triple-positivity for all three antibodies (LAC+,aCL+, β2GPI+, same isotype) results has demonstrated a high specificity for APS - a 90% risk, to be specific.13
Why you should add EliA assays for APS to your lab
The EliA APS tests are clinically relevant, and assays are designed to provide reliable and precise results.4 These assays utilize fluoroenzyme immunoassay (FEIA) technology, ensuring high sensitivity and specificity.5-11 The 2023 ACR/EULAR APS classification criteria includes solid-phase enzyme-linked immunosorbent assays for IgG/IgM anticardiolipin and/or IgG/IgM anti–ß2-glycoprotein I antibodies.3
Become a trusted source for APS diagnostics today.
Talk with us to learn more.
Gain the benefits of Phadia Laboratory Systems
EliA APS assays are run on Phadia™ Laboratory Systems.
Let our Phadia Laboratory Systems be the backbone in maximizing your lab's workflow – increasing lab productivity, reducing hands-on time, and lowering operational costs.
We offer:
Fully automated testing consolidated on one platform
Scalable solutions customizable to lab workflow
28-day isotype master calibration curve stability
Remote diagnostic capabilities
Instrument reliability to reduce unnecessary downtime
Educational support to maximize proper utilization of testing
Understanding test results
Once results are in, it's important to keep in mind that aPL antibodies are present in 5% of the healthy population.14 If the result of least one marker in the profile is moderate to high, testing again at 12 weeks is standard for confirmation.2
Interpretation tips: positive aPL ≠ APS
Not every positive aPL test is clinically significant (cannot judge on a positive/negative result only).15
aPL are present in 1-5% of the general population (increasing with age).14
Transient aPL positivity is common during infections. Serial blood draws are therefore important.15
Clinical judgement is required when interpreting significance of results.15
Consistent testing and follow-up are essential to confirm the diagnosis and guide treatment decisions.
Missed or delayed identification of APS introduces avoidable patient risk. When APS is appropriately tested, diagnosed, and treatedmore than 70% of pregnant women will deliver live newborns.16
Clinicians trust you. Patients depend on you. Let us help support you.
Your partner in autoimmune diagnostics
Unlock your lab’s potential with EliA™ autoimmune assays and Phadia Laboratory Systems today.
- Garcia D, et al. Diagnosis and Management of the Antiphospholipid Syndrome. N Engl J Med. 2018;378(21):2010-2021.
- Miyakis S, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006;4(2):295-306.
- Barbhaiya M, et al. 2023 ACR/EULAR Antiphospholipid Syndrome Classification Criteria. Arthritis Rheumatol. 2023.
- Zohoury N, et al. Closing the Serological Gap in the Antiphospholipid Syndrome: The Value of "Non-criteria" Antiphospholipid Antibodies. J Rheumatol. 2017;44(11):1597-1602.
- EliA β2-Glycoprotein I IgM Directions for Use. Phadia 250 Laboratory System. 2020.
- EliA β2-Glycoprotein I IgG Directions for Use. Phadia 250 Laboratory System. 2020.
- EliA β2-Glycoprotein I IgA Directions for Use. Phadia 250 Laboratory System. 2020.
- EliA Cardiolipin IgM Directions for Use. Phadia 250 Laboratory System. 2020.
- EliA Cardiolipin IgG Directions for Use. Phadia 250 Laboratory System. 2020.
- EliA Cardiolipin IgA Directions for Use. Phadia 250 Laboratory System. 2020.
- Villalta D, et al. Accuracy of the First Fully Automated Method for Anti-Cardiolipin and anti-beta2 Glycoprotein I Antibody Detection for the Diagnosis of Antiphospholipid Syndrome. Ann N Y Acad Sci. 2009;1173:21-27.
- Pérez D, et al. Evaluation of Three Fully Automated Immunoassay Systems for Detection of IgA Anti-Beta 2-glycoprotein I Antibodies. Int Jnl Lab Hem. 2016;38(5):560-568.
- Pengo V, et al. Confirmation of initial antiphospholipid antibody positivity depends on the antiphospholipid antibody profile. J Thromb Haemost. 2013;11(8):1527-1531.
- Misita CP, Moll S. Antiphospholipid antibodies. Circulation. 2005;112(3):e39-44.
- Cush J. Across the Table on Antiphospholipid Syndrome [Internet]. Medical News and Free CME Online. MedpageToday. 2017 [cited 2020 Dec 28]. Available from: https://www.medpagetoday.com/rheumatology/generalrheumatology/70213.
- Di Prima FA, et al. Antiphospholipid Syndrome during pregnancy: the state of the art. J Prenat Med. 2011;5(2):41-53.
