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Related Experiment Video

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Antiphospholipid IgG Certified Reference Material ERM®-DA477/IFCC: a tool for aPL harmonization?

Claudia Grossi1, Liesbet Deprez2, Caterina Bodio1

  • 1Immunorheumatology Research Laboratory, 9354 IRCCS Istituto Auxologico Italiano , Cusano Milanino, Italy.

Clinical Chemistry and Laboratory Medicine
|March 20, 2025
PubMed
Summary

A new reference material (CRM) ERM®-DA477/IFCC helps standardize laboratory diagnosis of antiphospholipid syndrome (APS). This CRM calibrates anti-beta2-glycoprotein I (anti-β2GPI) IgG methods, improving diagnostic consistency for APS patients.

Keywords:
Certified Reference Material (CRM)aPL-heterogeneityanti-cardiolipinanti-β2GPIantiphospholipid syndromemethod-calibration

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Area of Science:

  • Immunology
  • Clinical Chemistry
  • Reference Materials

Background:

  • Antiphospholipid syndrome (APS) diagnosis relies on detecting specific autoantibodies.
  • Harmonization of laboratory methods for anti-beta2-glycoprotein I (anti-β2GPI) IgG is crucial for accurate APS diagnosis.
  • Existing diagnostic methods show variability, impacting patient care.

Purpose of the Study:

  • To evaluate the Certified Reference Material (CRM) ERM®-DA477/IFCC for its ability to represent anti-β2GPI antibody heterogeneity in APS patients.
  • To assess the CRM's efficacy in calibrating IgG anti-β2GPI laboratory methods.
  • To determine if the CRM can improve the harmonization of anti-β2GPI IgG assays.

Main Methods:

  • Characterization of CRM reactivity against different domains of β2GPI using specific assays (QUANTA Flash®, in-house ELISAs).
  • Evaluation of CRM's anti-Cardiolipin (anti-CL) activity using various immunoassay platforms (QUANTA Lite® ELISA, QUANTA Flash® CLIA, EliA™ FEIA).
  • Assessment of CRM's calibration performance across four anti-β2GPI IgG methods using clinical samples and controls.

Main Results:

  • CRM demonstrated high anti-domain-1 and no anti-domain-4-5 activity, reflecting APS patient antibody profiles.
  • Acceptable dilution linearity was observed for anti-CL assays (R2 0.957–0.997).
  • Calibration with CRM improved comparability between anti-β2GPI IgG assays, achieving 85% concordance compared to 66% with assay-specific calibration.

Conclusions:

  • The CRM ERM®-DA477/IFCC effectively represents the heterogeneity of anti-β2GPI/CL antibodies found in APS patients.
  • The CRM has the potential to significantly improve the harmonization of anti-β2GPI IgG assays.
  • Achievable harmonization levels are influenced by the inherent selectivity differences among various diagnostic assays.