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Assessment of 2023 ACR/EULAR antiphospholipid syndrome classification criteria in a Spanish cohort

  • Rodrigo Cantera Estefanía ORCID logo EMAIL logo , Rafael Gálvez Sánchez , María Abando Casuso , José Antonio Flores García , Raquel García Ruiz , Irene Gorostidi Álvarez , Héctor Cruz Barquín , María Oviedo Madrid , Marina Herrero López , Ligia Gabriela Gabrie Rodríguez , Juan José Domínguez García , Ariadna García Ascacíbar , José Luis Hernández Hernández , Lucrecia Yáñez San Segundo ORCID logo , Belén González-Mesones Galán , María Luisa González Ponte , Marcos López Hoyos ORCID logo , Gala Aglaia Méndez Navarro , Sara del Barrio Longarela und Víctor Manuel Martínez Taboada ORCID logo
Veröffentlicht/Copyright: 14. Juli 2025
Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 63 Heft 11

Abstract

Objectives

The 2023 ACR/EULAR criteria aim to improve the classification of antiphospholipid syndrome (APS). This study aims to validate these criteria and compare clinical and laboratory domains between classified and non-classified patients.

Methods

A retrospective cohort study was conducted at the Hospital Universitario Marqués de Valdecilla, a tertiary referral center in Cantabria, Spain. Data were retrieved from the laboratory information system, identifying patients with at least one positive determination of lupus anticoagulant (LA), anticardiolipin (aCL), or anti-β2 glycoprotein I (anti-β2GPI) between January 2018 and March 2024. Patients were classified according to the 2006 Sydney and 2023 ACR/EULAR criteria.

Results

Among 375 patients meeting the Sydney criteria, 152 (40.6 %) fulfilled the 2023 ACR/EULAR criteria. The sensitivity and specificity of the 2023 ACR/EULAR criteria were 30.2 and 97.7 % respectively, with a positive predictive value of 0.84, and a negative predictive value of 0.77. Area under the ROC curve was 0.639 (95 % CI: 0.605–0.673). The exclusion of thrombosis with high-risk thrombotic profiles and recurrent pregnancy loss or fetal death as individual events on obstetric APS accounted for most declassified patients. Additionally, patients meeting the 2023 ACR/EULAR criteria had a higher prevalence of arterial thrombosis without cardiovascular risk factors. In laboratory domains, isolated IgM aPL positivity was a major exclusion factor due to its lower weight in the new criteria.

Conclusions

The 2023 ACR/EULAR criteria enhance specificity but significantly reduce sensitivity, excluding many APS patients, particularly those with obstetric APS or IgM aPL. This raises concerns about clinical trial eligibility and applicability in diverse populations.

Keywords: antiphospholipid syndrome; classification criteria; aPL carrier; antiphospholipid antibody
Corresponding author: Rodrigo Cantera Estefanía, Hematology Department, University Hospital of Navarra, C. Irunlarrea 3, 31008, Pamplona, Navarra, Spain, E-mail:

  1. Research ethics: This study was approved by Cantabria Ethics Committee for Research with Medicines and Healthcare Products (CEIm2024.111).

  2. Informed consent: No informed consent was obtained. Exemption for use of informed consent was obtained from Cantabria Ethics Committee for Research with Medicines and Healthcare Products.

  3. Author contributions: RCE and VMMT contributed to the design of the study, lead the statistical analysis, writing, and critical revision of the final manuscript. RCE lead the data collection. RGS, MAC, JAFG, RGR, IGA, HCB, MOM, MHL, LGGR, AGA and SDBL contributed to data collection. JLHH, LYSS and JJDG contributed to statistical analysis. All authors contributed to a literature review on the topic and a critical revision of the manuscript. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: Data is electronically stored and available for sharing upon reasonable request.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2025-0508).

Received: 2025-03-11
Accepted: 2025-06-19
Published Online: 2025-07-14
Published in Print: 2025-10-27

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2025-0508
Schlagwörter für diesen Artikel
antiphospholipid syndrome; classification criteria; aPL carrier; antiphospholipid antibody

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Advancing diagnostic stewardship through claims-based utilization analysis: toward a system-wide vision of diagnostic excellence
  4. Review
  5. Biomarkers in body fluids and their detection techniques for human intestinal permeability assessment
  6. Mini Review
  7. Challenges of using natriuretic peptides to screen for the risk of developing heart failure in patients with diabetes: a report from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Committee on Clinical Applications of Cardiac Bio-Markers (C-CB)
  8. Opinion Papers
  9. Reference intervals in value-based laboratory medicine: a shift from single-point measurements to metabolic variation-based models
  10. Overview of laboratory diagnostics for immediate management of patients presenting to the emergency department with acute bleeding
  11. What Matters Most: an Age-Friendly approach to pathology and laboratory medicine
  12. No fault or negligence after an adverse analytical finding due to a contaminated supplement: mission impossible. Two examples involving trimetazidine
  13. General Clinical Chemistry and Laboratory Medicine
  14. Utilization analysis of laboratory tests using health insurance claims data: advancing nationwide diagnostic stewardship monitoring systems
  15. Evaluating large language models as clinical laboratory test recommenders in primary and emergency care: a crucial step in clinical decision making
  16. A novel corrective model based on red blood cells indices and haemolysis index enables accurate unhaemolysed potassium determination in haemolysed samples – Hemokalc project
  17. Validation of (self-collected) capillary blood using a topper collection system as alternative for venous sampling for 15 common clinical chemistry analytes
  18. Acoustophoresis-based blood sampling and plasma separation for potentially minimizing sampling-related blood loss
  19. Clinical validation of a liquid chromatography single quadrupole mass spectrometry (LC-MS) method using Waters Kairos™ Amino Acid Kit reagents
  20. Robustness of steroidomics-based machine learning for diagnosis of primary aldosteronism: a laboratory medicine perspective
  21. Investigation of the possible cause of over-estimation of human aldosterone in plasma, using a unique, non-synthetic human aldosterone-free matrix
  22. Performance of afternoon (16:00 h) serum cortisol for the diagnosis of Cushing’s syndrome
  23. MAGLUMI® Tacrolimus (CLIA) assay: analytical performances and comparison with LC-MS/MS and ARCHITECT Tacrolimus (CMIA) assay
  24. Assessment of 2023 ACR/EULAR antiphospholipid syndrome classification criteria in a Spanish cohort
  25. Comprehensive evaluation of antiphospholipid antibody testing methodologies in APS diagnosis: performance comparisons across assay systems and clinical subtypes
  26. Candidate Reference Measurement Procedures and Materials
  27. Exploring commutable materials for serum folate measurement: challenges in cross-method harmonization
  28. Reference Values and Biological Variations
  29. Reference ranges for ionized calcium in plasma in Danish children aged 0 days to 3 years using laboratory registry data
  30. A step forward in pediatric hemophagocytic lymphohistiocytosis and autoimmune disease: pediatric reference interval for serum soluble IL-2 receptor and soluble CD163
  31. Cancer Diagnostics
  32. Cellular expression of PD-1, PD-L1 and CTLA-4 in patients with JAK2V617F mutated myeloproliferative disorders
  33. Diabetes
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  35. Infectious Diseases
  36. An assessment of molecular diagnosis of tuberculosis and multi-drug resistant tuberculosis testing and quality assessment: findings of an international survey
  37. Letters to the Editor
  38. Targeting low-value laboratory care
  39. Is time a significant factor in the release of potassium from lithium heparin plasma and serum?
  40. External quality assessment in resource-constrained laboratories: a survey of practices and perceptions in Nepal
  41. Is successfulness of platelet clump disaggregation by vortexing influenced by platelet measurement methods?
  42. Oligoclonal banding analysis: assessing plasma use and time interval requirements for paired CSF and blood
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