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Technical and clinical evaluation of anti‐ribosomal P protein immunoassays

Autoantibodies to the three ribosomal phospho (‐P) proteins P0, P1, P2, referred to as Rib‐P, are specifically found in 10–40% of patients with systemic lupus erythematosus. The variations in the observed frequency of these autoantibodies is related to a number of factors such as the test system used to detect the antibodies. Several immunoassays that were designed for research and diagnostic laboratory use have been developed. The autoantigens employed in these tests include native proteins, recombinant polypeptides, and synthetic peptides. In this study, we compared the technical and clinical accuracy of anti‐Rib‐P antibody assays from different commercial suppliers including ELISA systems and a novel addressable laser bead assay (from Euroimmun, MBL, Pharmacia Diagnostics, INOVA). Although the assays from all suppliers used in this study performed well in the technical part of the study, relatively poor correlations and significant differences in the clinical accuracy were found. Based on the results, we conclude that the detection of anti‐Rib‐P antibodies strongly depends on both the nature of the antigen and the detection system. We recommend that anti‐Rib‐P assays should be standardized on an international level. The Varelisa® Rib‐P profile and the addressable laser bead Rib‐P assays represent promising tools and platforms for the detection of anti‐Rib‐P antibodies in the future. J. Clin. Lab. Anal. 18:215‐223, 2004. © 2004 Wiley‐Liss, Inc.