The performance of different anti-dsDNA autoantibodies assays in Chinese systemic lupus erythematosus patients.

To compare the performance of different commercial anti-dsDNA autoantibody assays, including multiplex-based immunoassay (Bio-Plex), Farr radioimmunoassay (Farr), ELISA, chemiluminescent immunoassay (CLIA), and Crithidia Luciliae indirect immunofluorescence test (CLIFT) in Chinese patients with systemic lupus erythematosus (SLE). SLE patients (n = 119) as well as healthy controls (n = 200) and disease controls (n = 100) were recruited, and serum anti-dsDNA autoantibodies were detected by Bio-Plex, Farr, two ELISA assays (Medical & Biological Laboratories-ELISA, EUROIMMU-ELISA), CLIA, and a standard CLIFT. The correlation of anti-dsDNA autoantibody levels to SLE disease activity was calculated, and the specificity and sensitivity of these methods were measured by receiver-operator characteristic (ROC) curve analysis. In ROC curve analysis, Bio-Plex showed the largest area under the curve (AUC) over other assays. Cutoff adjustment according to ROC enhanced the performance of all quantitative assays. Overall, Bio-Plex and CLIFT have higher specificity (>90.00%). ELISA and CLIA results are correlated with disease activity, and Bio-Plex results have the strongest correlation with SLEDAI score and active renal involvement. Bio-Plex assay has better overall performance in anti-dsDNA detection over Farr, ELISA, and CLIA methods in Chinese SLE patients.