Clinical performance of three anti-dsDNA antibody immunoassays in systemic lupus erythematosus

To evaluate the clinical performance of three commercially available anti-double-stranded DNA (dsDNA) antibody immunoassays in Japan.

We compared the reactivity and diagnostic accuracy of three commercially available anti-dsDNA antibody immunoassays (radioimmunoassay, chemiluminescence enzyme immunoassay, and fluorescence enzyme immunoassay). We evaluated how well the three anti-dsDNA antibody immunoassays reflected disease activity and individual organ involvement in systemic lupus erythematosus.

Three anti-dsDNA antibody immunoassays demonstrated moderate to substantial correlation and concordance, while some patients exhibited different reactivity because of assay principles and detection systems. The diagnostic accuracies of the three immunoassays were comparable based on the receiver operating characteristic analyses and optimal cutoff values. Among the three anti-dsDNA antibody immunoassays, a fully automated chemiluminescence enzyme immunoassay-specific detection system demonstrated high sensitivity that reflects disease activity. The combined results of the titers and positivity rates of the three anti-dsDNA antibody immunoassays showed that nephritis was significantly associated with the chemiluminescence enzyme immunoassay and arthritis with the radioimmunoassay, and weak or no associations with other organ involvement were observed.

We confirmed that the clinical performances of the three dsDNA immunoassays are comparable. Our findings suggest that selecting an optimal anti-dsDNA immunoassay will be useful for clinical decision-making in systemic lupus erythematosus.