A WHO Reference Reagent for lupus (anti-dsDNA) antibodies: International collaborative study to evaluate a candidate preparation

Bernard J. Fox, Jason Hockley, Peter Rigsby, Carl Dolman, Pier Luigi Meroni, Johan Rönnelid

Research output: Contribution to journalArticlepeer-review


Introduction Antibodies against double-stranded DNA (anti-dsDNA) are a specific biomarker for systemic lupus erythematosus (SLE). The first WHO International Standard (IS) for anti-dsDNA (established in 1985), which was used to assign units to diagnostic tests, was exhausted over a decade ago. Methods Plasma from a patient with SLE was first evaluated in 42 European laboratories. The plasma was thereafter used by the National Institute for Biological Standards and Control to prepare a candidate WHO reference preparation for lupus (anti-dsDNA) antibodies. That preparation, coded 15/174, was subjected to an international collaborative study, including 36 laboratories from 17 countries. Results The plasma mainly contained anti-dsDNA, other anti-chromatin antibodies and anti-Ku. The international collaborative study showed that the field would benefit from 15/174 as a common reference reagent improving differences in performance between different assays. However, no statistically meaningful overall potency or assay parallelism and commutability could be shown. Conclusion 15/174 cannot be considered equivalent to the first IS for anti-dsDNA (Wo/80) and was established as a WHO Reference Reagent for lupus (oligo-specific) anti-dsDNA antibodies with a nominal value of 100 units/ampoule. This preparation is intended to be used to align test methods quantifying levels of anti-dsDNA antibodies.

Original languageEnglish
Pages (from-to)1677-1680
Number of pages4
JournalAnnals of the Rheumatic Diseases
Issue number12
Publication statusPublished - Dec 1 2019


  • autoantibodies
  • autoimmune diseases
  • systemic lupus erythematosus

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)


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