Comparative analysis of multiplex AtheNA Multi-Lyte ANA test system and conventional laboratory methods to detect autoantibodies

Abstract

Introduction: New technologies that employ multiplexed bead based immunoassays have contributed to the improvement in the diagnosis and monitoring of autoimmune diseases. The aim of this study was to determine the performance of multiplexed bead based immunoassay (AtheNA Multi-Lyte ANA test system) relative to established indirect immunofluorescent analysis (IIF ANA) and enzyme-linked immunosorbent assay (ELISA) currently used in our laboratory. Mateirials and methods: 897 serum specimens were tested with AtheNA Multi-Lyte ANA test system for nine analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, dsDNA, Centromere B and Histone), and With IIF ANA. Only positive specimens were tested with single-antigen ELISA and compared with AtheNA Multi-Lyte ANA. Results: There was a complete concordance between multiplexed bead based immunoassay and IIF ANA in 92.3% cases (70% of total cases were negative and 22.3% positive). For specific autoantibodies, sensitivity ranged from 80.0% (Scl-70) to 100% (SSA), and specificity from 92.3% (ds DNA) to 98.3% (Sm) for AtheNA Multi-Lyte ANA and ELISA. All positive sera (200) were tested by single antigen ELISA test and compared with results obtained With AtheNA Multi-Lyte ANA test system. The correlation established for all autoantibodies was significant (P < 0.001), as well as the kappa value (P < 0.001). Conclusion: Our results showed that the AtheNA Multi-Lyte test system could replace single antigen ELISA test for the measurement of specific autoantibodies, but not completely the IIF ANA method in an immunology laboratory.