WHO/BS/2017.2306 Collaborative study for Proposed 1 st WHO International Standard for Lupus (anti-dsDNA) antibodies (15/174)

Overview

Systemic Lupus Erythematosus (SLE) is a severe auto-immune connective tissue disease, in which antibodies are generated to a range of autoantigens. Among these autoantigens, antibodies to double stranded DNA (anti-dsDNA), are highly specific for SLE, occurring in 70% of cases of SLE (against a non-SLE background of <5%). The levels of anti-ds DNA antibodies can also reflect the disease activity. As a result, measurement of anti-dsDNA is widely used as a diagnostic test for SLE, and there are a range of kits and diagnostic tests available.

In the present study, oligo-specific SLE plasma was prepared as a lyophilised candidate standard for anti-dsDNA antibodies. The candidate standard was examined in an international collaborative study (36 laboratories in 17 countries), and compared with - Local standards some of which were previously calibrated and traced to the first WHO IS for anti-dsDNA antibodies - Three individual plasma donations from patients with SLE, to support evaluation of commutability of the candidate IS.