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

ABSTRACT:

Objectives

The Certified Reference Material (CRM) ERM^®-DA477/IFCC is a new polyclonal IgG anti-beta2-glycoprotein I (anti-β2GPI) material for the harmonization of the laboratory diagnosis of antiphospholipid syndrome (APS). We evaluated CRM's ability to represent the heterogeneity of APS patient anti-β2GPI antibodies and to calibrate IgG anti-β2GPI methods.

Methods

We characterized CRM for its reactivity against domain-1, using the QUANTA Flash^® β2GPI-domain-1 assay, and against domains-4-5 of β2GPI, and single-domain-deleted β2GPI molecules using in-house ELISAs. We used QUANTA Lite^® ELISA, QUANTA Flash^® CLIA, and EliA™ FEIA methods to evaluate the CRM's anti-Cardiolipin (anti-CL) activity. Four anti-β2GPI IgG methods (in-house an

SUBMITTER: Grossi C 

PROVIDER: S-EPMC12118607 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature