Abstract
Objective. We aimed to compare a chemiluminescent immunoassay (CIA, QUANTA Flash) on BIO-FLASH with a multiplex flow immunoassay (MFI) on BioPlex 2200 for the detection of antibodies to Ro60, Ro52, and SS-B. Methods. The study included 241 samples, from patients suffering from systemic autoimmune diseases (n = 108) as well as disease controls (n = 133). All samples were tested for anti-Ro52, anti-Ro60, and anti-SS-B (La) antibodies on QUANTA Flash (INOVA Diagnostics, San Diego, USA) and BioPlex 2200 (Bio-Rad Laboratories Inc., Hercules, USA). Discrepant samples were tested by two independent methods: BlueDot/ANA and QUANTRIX Microarray (both D-tek, Belgium). Results. The overall qualitative agreements were 95.4% (95% confidence interval, CI 92.0–97.7%) for anti-Ro52, 98.8% (95% CI 96.4–99.7%) for anti-Ro60, and 91.7% (95% CI 87.5–94.9%) for anti-SS-B antibodies. There were 34 discrepant samples among all assays (20 anti-SS-B, 11 anti-Ro52, 3 anti-Ro60). 30/33 of retested samples (by D-tek dot blot) agreed with the QUANTA Flash results. Similar findings were obtained with QUANTRIX Microarray kit. Conclusion. QUANTA Flash and BioPlex 2200 show good qualitative agreement. The clinical performances were similar for anti-Ro52 and anti-Ro60 autoantibodies while differences were observed for anti-SS-B (La) antibodies.
Highlights
Autoantibodies targeting extractable nuclear antigens (ENA) are hallmarks in the diagnosis of systemic autoimmune rheumatic disease (SARD) such as systemic lupus erythematosus (SLE), Sjogren’s syndrome (SjS), systemic sclerosis (SSc), polymyositis/dermatomyositis (PM/DM), and mixed connective tissue disease (MCTD)
The overall qualitative agreements between QUANTA Flash and BioPlex 2200 were 95.4% (95% confidence interval, CI 92.0–97.7%) for anti-Ro52, 98.8% for anti-Ro60, and 91.7% for anti-SS-B antibodies (Table 2)
Using Receiver operating characteristics (ROC) analyses with the BioPlex 2200 results as the comparator, excellent agreement was found for anti-Ro60, good for anti-Ro52, and moderate for anti-SS-B antibodies
Summary
Autoantibodies targeting extractable nuclear antigens (ENA) are hallmarks in the diagnosis of systemic autoimmune rheumatic disease (SARD) such as systemic lupus erythematosus (SLE), Sjogren’s syndrome (SjS), systemic sclerosis (SSc), polymyositis/dermatomyositis (PM/DM), and mixed connective tissue disease (MCTD). Anti-ENA antibodies can be detected in undifferentiated connective tissue disease (UCTD) [1]. The primary antigenic targets of anti-ENA antibodies are U1-ribonucleoproteins (RNP), Sm (Smith antigen) [2], Scl-70 (topoisomerase I) [3], Jo-1, Ro60 (SS-A) [4], Ro52 (TRIM21) [4], and SS-B (La) [1]. Not all of those antibodies are specific for a particular disease but are useful to help ruling in or out SARD [1]. The chemiluminescence technology, which has been used
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