Multicenter Analytical Comparison of Automated Quantitative Assays Versus Line Immunoassay for Anti‐Ro/La Antibody Detection in Primary Sjögren’s Syndrome
Source: PubMed Central Open Access, NCBI / U.S. National Library of Medicine
Objective This multicenter study aimed to analytically compare the performance of automated quantitative assays—chemiluminescence immunoassay (CLIA) and multiplexed bead immunoassay (MBI)—for detecting anti‐Ro/La antibodies in Chinese patients with primary Sjögren’s syndrome (pSS), compared to line immunoassay (LIA) that is most commonly used in China. sec-0001 Methods Based on the Chinese Sjögren’s Syndrome Collaborative Research Group, serum samples from 434 patients with pSS and 100 healthy controls were analyzed using LIA, CLIA, and MBI. Sensitivity, specificity, and qualitative agreement were assessed. Receiver operating characteristic (ROC) analysis was carried out to compare the analytical accuracy among assays in detecting anti‐Ro/La antibodies, and the DeLong test was used to compare areas under curves (AUCs). sec-0002 Results High specificity (95% to 100%) was observed in these assays, and LIA demonstrated the highest sensitivity for anti‐Ro60 (92.6%) and anti‐Ro52 (89.2%). CLIA and MBI exhibited comparable sensitivity to LIA for anti‐La (50.9% vs. 50.2% vs. 48.2%). Qualitative agreement among assays was good for anti‐Ro60 (: 0.84–0.93) and moderate for anti‐La (: 0.74–0.86). MBI achieved the highest AUC values for anti‐Ro60 (0.980), anti‐Ro52 (0.970), and anti‐La (0.935), outperforming CLIA and LIA (< 0.05). sec-0003 Conclusion Automated assays (CLIA and MBI) demonstrate high specificity and analytical accuracy for anti‐Ro/La antibody detection in pSS. MBI achieved
Abstract
Objective This multicenter study aimed to analytically compare the performance of automated quantitative assays—chemiluminescence immunoassay (CLIA) and multiplexed bead immunoassay (MBI)—for detecting anti‐Ro/La antibodies in Chinese patients with primary Sjögren’s syndrome (pSS), compared to line immunoassay (LIA) that is most commonly used in China. sec-0001 Methods Based on the Chinese Sjögren’s Syndrome Collaborative Research Group, serum samples from 434 patients with pSS and 100 healthy controls were analyzed using LIA, CLIA, and MBI. Sensitivity, specificity, and qualitative agreement were assessed. Receiver operating characteristic (ROC) analysis was carried out to compare the analytical accuracy among assays in detecting anti‐Ro/La antibodies, and the DeLong test was used to compare areas under curves (AUCs). sec-0002 Results High specificity (95% to 100%) was observed in these assays, and LIA demonstrated the highest sensitivity for anti‐Ro60 (92.6%) and anti‐Ro52 (89.2%). CLIA and MBI exhibited comparable sensitivity to LIA for anti‐La (50.9% vs. 50.2% vs. 48.2%). Qualitative agreement among assays was good for anti‐Ro60 (: 0.84–0.93) and moderate for anti‐La (: 0.74–0.86). MBI achieved the highest AUC values for anti‐Ro60 (0.980), anti‐Ro52 (0.970), and anti‐La (0.935), outperforming CLIA and LIA (< 0.05). sec-0003 Conclusion Automated assays (CLIA and MBI) demonstrate high specificity and analytical accuracy for anti‐Ro/La antibody detection in pSS. MBI achieved the highest accuracy, whereas LIA showed superior sensitivity for anti‐Ro60/52 detection. CLIA provided reliable specificity but failed to detect anti‐Ro52 in this study. Collectively, these findings indicate that CLIA and MBI may represent reliable alternatives to LIA, although validation in disease‐controlled cohorts is required before clinical implementation. sec-0004