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A WHO Reference Reagent for lupus (anti-dsDNA) antibodies: international collaborative study to evaluate a candidate preparation
Natl Inst Biol Stand & Controls, Div Biotherapeut, Potters Bar EN6 3QG, Herts, England.ORCID iD: 0000-0001-6362-5196
Natl Inst Biol Stand & Controls, Div Analyt & Biol Sci, Potters Bar, Herts, England.
Natl Inst Biol Stand & Controls, Div Analyt & Biol Sci, Potters Bar, Herts, England.
Natl Inst Biol Stand & Controls, Div Biotherapeut, Potters Bar EN6 3QG, Herts, England.
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2019 (English)In: Annals of the Rheumatic Diseases, ISSN 0003-4967, E-ISSN 1468-2060, Vol. 78, no 12, p. 1677-1680Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2019. Vol. 78, no 12, p. 1677-1680
National Category
Rheumatology and Autoimmunity
Identifiers
URN: urn:nbn:se:uu:diva-400760DOI: 10.1136/annrheumdis-2019-215845ISI: 000500726200023PubMedID: 31488407OAI: oai:DiVA.org:uu-400760DiVA, id: diva2:1382490
Available from: 2020-01-03 Created: 2020-01-03 Last updated: 2020-01-03Bibliographically approved

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