Analytical and clinical performance of different platforms simultaneously detecting 15 antinuclear antibodies.

Abstract

BackgroundAntinuclear antibodies (ANAs) are invaluable biomarkers for the diagnosis of autoimmune diseases (AIDs). This study aims to compare the performances of line immunoassay (LIA), multiplex bead‐based flow fluorescent immunoassay (MBFFI), and magnetic bar code immunofluorescence assay (MBC‐IF) to detect ANA‐Profile‐15S.MethodsIn total, 184 samples from AID patients and 50 healthy controls (HCs) were collected. Fifteen ANAs (anti‐dsDNA, nucleosome, histone, Sm, PCNA, ribosomal‐P, SS‐A/Ro52, SS‐A/Ro60, SS‐B/La, centromere B [CENP‐B], Scl‐70, U1‐snRNP, AMA‐M2, Jo‐1, and Pm/Scl) were subjected to parallel detection by the LIA, MBFFI, and MBC‐IF. The consistency between assays was analyzed. The discrepant results were further examined by chemiluminescent immunoassay (CLIA).ResultsAnti‐SS‐A/Ro52 and SS‐A/Ro60 autoantibodies were the most common autoantibodies in ANA positive‐profiles, and were detected with equal efficiency by the LIA, MBFFI, and MBC‐IF (p = 0.101 and p = 0.732, respectively). The three assays showed excellent agreement (consistency range: 66.5%–97.5%), and total consistency was 85.8%. The MBFFI and MBC‐IF assays were in good agreement in terms of ANA‐Profile‐15S determination; the kappa coefficient ranged from 0.59 to 0.95, except for the PCNA and PM‐Scl. Of the 262 re‐assessed divergent results, 124 (47.33%) were positive on CLIA; the various autoantibodies exhibited variable patterns. More importantly, the ANA‐Profile‐15S results of the MBFFI and MBC‐IF accurately identified patients with AID; the area under the curves ranged from 0.642 to 0.919.ConclusionsThe novel MBFFI and MBC‐IF assay performed well in detecting ANA‐Profile‐15S. The application of MBFFI and MBC‐IF play important roles in laboratory diagnosis of AIDs.