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Antiphospholipid Antibody Testing in a Maximum Care Hospital: Method-Dependent Differences.

Marija Kocijancic1, Thomas Goj1, Andreas Peter1,2,3

  • 1Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, University Hospital Tübingen, 72076 Tübingen, Germany.

Journal of Clinical Medicine
|August 10, 2024
PubMed
Summary

Comparing enzyme-linked immunosorbent assays (ELISAs) and chemiluminescence immunoassays (CLIAs) for antiphospholipid antibody (aPL) testing revealed significant method-dependent discrepancies. Careful interpretation of aPL results is crucial for accurate antiphospholipid syndrome classification.

Keywords:
anti-beta2 glycoprotein I antibodiesantibody assayanticardiolipin antibodiesantiphospholipid syndrome

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Area of Science:

  • Clinical immunology and diagnostics
  • Autoantibody detection methods
  • Rheumatology and autoimmune diseases

Background:

  • Antiphospholipid antibody (aPL) testing is essential for diagnosing antiphospholipid syndrome (APS).
  • The 2023 ACR/EULAR classification criteria emphasize enzyme-linked immunosorbent assays (ELISAs) and specific positivity thresholds.
  • Increasing use of non-ELISA methods necessitates comparison with traditional ELISAs in clinical practice.

Purpose of the Study:

  • To compare and evaluate the performance of ELISA and non-ELISA (chemiluminescence immunoassay - CLIA) antiphospholipid antibody assays.
  • To assess the agreement and clinical relevance of these methods in a real-world hospital setting.
  • To determine the impact of assay methodology on the classification of antiphospholipid syndrome.

Main Methods:

  • Anticardiolipin (aCL) and anti-beta2 glycoprotein I (aß2GPI) antibodies (IgG and IgM) were measured using ELISA and CLIA.
  • Parallel testing was conducted on 946 samples between January 2021 and June 2024.
  • Results were compared for agreement and association with clinical and laboratory characteristics, including APS diagnosis.

Main Results:

  • Overall agreement between ELISA and CLIA was acceptable only for aß2GPI IgG; poor agreement was observed for aCL IgG/IgM and aß2GPI IgM.
  • In APS patients, agreement was acceptable for aß2GPI IgG and IgM but poor for aCL IgG and IgM.
  • CLIA showed significantly higher antibody levels in APS patients compared to ELISA, impacting positivity rates and classification.

Conclusions:

  • Substantial method-dependent discrepancies exist between ELISA and CLIA for aPL testing, affecting both quantitative and qualitative results.
  • While both methods can be used for APS classification, the choice of assay can influence diagnostic outcomes.
  • Clinical interpretation of aPL results requires careful consideration of the specific assay method employed.