Standards and reference materials for the anticardiolipin and anti-β 2glycoprotein I assays: A report of recommendations from the APL Task Force at the 13th International Congress on Antiphospholipid Antibodies

Silvia S. Pierangeli, Emmanuel J. Favaloro, Gabriella Lakos, Pier Luigi Meroni, Angela Tincani, Richard C W Wong, E. Nigel Harris

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The confirmation of diagnosis of the Antiphospholipid Syndrome (APS) relies on laboratory tests. Current classification criteria for definite APS mandate the use of three "standardized" laboratory assays to detect antiphospholipid antibodies (aPL) [viz: anticardiolipin (aCL) IgG and IgM, anti-β 2glycoprotein I (anti-β 2GPI) antibodies IgG and IgM and/or a lupus anticoagulant (LAC)], when at least one of the two major clinical manifestations (thrombosis or pregnancy losses) are present. Several attempts have been made to standardize the aCL and anti-β 2GPI tests, though, a considerable degree of inconsistencies still exist, limiting the clinical and diagnostic value of aPL tests. Among the areas of concern are the type and source of calibrant material, the lack of proper validated reference material and of universal units of measurement, particularly for anti-β 2GPI antibodies. Content: A Task Force of scientists and leaders in the field from different countries - discussed and analyzed those critical questions in an evidence-based manner and further discussed and made recommendations at a workshop that was conducted during 13th International Congress on Antiphospholipid Antibodies (APLA 2010, April 13-16, 2010, Galveston, TX). Summary: This concise report summarizes the findings, conclusions and recommendations of the task force and preconference workshop. The group recommended to ensure the availability of properly prepared and validated polyclonal and monoclonal antibody reference materials for both assays, to continue reporting the aCL assay in GPL/MPL units and to establish consensus international units of measurement for anti-β 2GPI antibodies.

Original languageEnglish
Pages (from-to)358-360
Number of pages3
JournalClinica Chimica Acta
Volume413
Issue number1-2
DOIs
Publication statusPublished - Jan 18 2012

Keywords

  • Anti-β glycoprotein I antibodies
  • Anticardiolipin antibodies
  • Antiphospholipid antibodies
  • Calibrators
  • Units of measurement

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical

Fingerprint Dive into the research topics of 'Standards and reference materials for the anticardiolipin and anti-β 2glycoprotein I assays: A report of recommendations from the APL Task Force at the 13th International Congress on Antiphospholipid Antibodies'. Together they form a unique fingerprint.

Cite this