Cited by 92Systemic Lupus Erythematosus ResearchVasculitis and related conditionsBlood Coagulation and Thrombosis Mechanisms

An update on laboratory detection and interpretation of antiphospholipid antibodies for diagnosis of antiphospholipid syndrome: guidance from the ISTH-SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies

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Devreese, Katrien M.J., Bertolaccini, Maria Laura, Branch, D. Ware, de Laat, Bas, Erkan, Doruk, Favaloro, Emmanuel J., Pengo, Vittorio, Ortel, Thomas L. +2 more·2025·Journal of Thrombosis and Haemostasis

Abstract

Antiphospholipid syndrome (APS) diagnosis is dependent on the accurate detection and interpretation of antiphospholipid antibodies (aPL). Lupus anticoagulant (LA), anticardiolipin antibodies (aCL), and anti-beta2 glycoprotein I antibodies (aβ2GPI) remain the cornerstone of the laboratory part of APS diagnosis. In the 2023 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) APS classification criteria, the type of laboratory parameters remain essentially unchanged compared with the updated Sapporo classification criteria, and aCL and aβ2GPI measurement are still restricted to enzyme-linked immunosorbent assays (ELISAs) with moderate and high titer aPL thresholds defined as 40 and 80 Units, respectively, and a cutoff calculated by the 99th percentile has been abandoned. We must differentiate between classification criteria and assessment of aPL in clinical care. Classification criteria are strict and meant for participant inclusion in studies and trials to study homogeneous populations of patients. In contrast, laboratory detection for APS diagnosis in daily practice is broader, meant to diagnose each APS patient to optimize their management. Nowadays, there is increasing use of measurement of aPL by methods other than ELISAs , the semiquantitative reporting of titers is a matter of debate, as well as the role of the isotypes immunoglobulin (Ig)M and IgA, and the role of other aPL, such as antiphosphatidylserine (aPS)/prothrombin (PT) antibodies. Patients diagnosed with the disease may or may not fulfill the classification criteria, and inappropriate use of classification criteria may lead to mis(under)diagnosis. The aim of this guidance, based on literature and expert opinion, is to provide guidance recommendations for laboratory workers and clinicians on routine diagnostic assessment of patients with suspected APS.

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Crossref · 10.1016/j.jtha.2024.10.022

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  1. Devreese, 2014, J Thromb Haemost, 12, 55, 10.1111/jth.12537 · DOI · Paper page

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Authors
Devreese, K. M. J., Bertolaccini, M. L., Branch, D. W., de Laat, B., Erkan, D., Favaloro, E. J., Pengo, V., Ortel, T. L., Wahl, D., & Cohen, H.
Affiliations
  • Ghent University Hospital (BE)
  • University of Utah (US)
  • Hospital for Special Surgery (US)
  • Westmead Hospital (AU)
  • University of Padua (IT)
  • Duke University (US)
  • Inserm (FR)
  • University College London Hospitals NHS Foundation Trust (GB)
Corresponding author
Devreese, Katrien M.J.
Venue
Journal of Thrombosis and Haemostasis
Publisher
Elsevier BV
Published
2025-02
Volume
23
Issue
2
Pages
731-744
ISSN
1538-7836 (ISSN-L)
OpenAlex
W4404056451
Cited by
92
References
118
Citations by year
2026: 54 · 2025: 38
FWCI
25.04
Type
journal article
Language
en
Open access
Locations
  • Journal of Thrombosis and Haemostasis (publishedVersion)
  • PubMed (publishedVersion)
  • Ghent University Academic Bibliography (Ghent University) (submittedVersion)
Topics
  • Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Vasculitis and related conditions
  • Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
Keywords
antiphospholipid syndrome, antiphospholipid antibodies, lupus anticoagulant, anticardiolipin antibodies, anti-beta2-glycoprotein I antibodies, anti-phosphatidylserine/prothrombin antibodies, ACR/EULAR classification criteria, antibody titer thresholds, ELISA, isotype-specific antibodies, laboratory diagnosis
MeSH terms
Enzyme-Linked Immunosorbent Assay, Humans, Predictive Value of Tests, Reproducibility of Results, Biomarkers, Lupus Coagulation Inhibitor, Antiphospholipid Syndrome, Antibodies, Antiphospholipid, Antibodies, Anticardiolipin, Consensus, beta 2-Glycoprotein I

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