Retrospective Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Oct 6, 2023; 11(28): 6688-6697
Published online Oct 6, 2023. doi: 10.12998/wjcc.v11.i28.6688
Clinical value of chemiluminescence method for detection of antinuclear antibody profiles
Hui-Yao Xiang, Xi-Ying Xiang, Ting-Bo Ten, Xie Ding, Yu-Wen Liu, Chun-Hua Luo
Hui-Yao Xiang, Xi-Ying Xiang, Ting-Bo Ten, Xie Ding, Yu-Wen Liu, Chun-Hua Luo, Medical Laboratory Science, The First College of Clinical Medical Science, China Three Gorges University, Yichang Central People's Hospital, Yichang 443003, Hubei Province, China
Author contributions: Xiang HY and Xiang XY proposed the concept of this study; Ten TB and Ding X contributed to data collection; Liu YW and Luo CH contributed to formal analysis; Luo CH and Xiang HY participated in the investigation; Xiang XY and Ten TB have contributed to these methods; Xiang HY, Xiang XY, Luo CH guide the research; Ding X validated this study; Xiang HY and Luo CH contributed to the visualization of this study; Xiang HY and Xiang XY have prepared the first draft; Xiang HY, Xiang XY, Ten TB, Ding X, Liu YW, and Luo CH reviewed and edited the manuscript.
Institutional review board statement: This research has been approved ethically by Yichang Central People's Hospital (The First Clinical School of China Three Gorges University, China).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors declare that there are no conflicts of interest.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Chun-Hua Luo, MD, Attending Doctor, Medical Laboratory Science, The First College of Clinical Medical Science, China Three Gorges University, Yichang Central People's Hospital, No. 183 Yiling Avenue, Yichang 443003, Hubei Province, China. douxia833@126.com
Received: July 6, 2023
Peer-review started: July 6, 2023
First decision: July 27, 2023
Revised: July 28, 2023
Accepted: August 31, 2023
Article in press: August 31, 2023
Published online: October 6, 2023
Processing time: 81 Days and 2.3 Hours
ARTICLE HIGHLIGHTS
Research background

Antinuclear antibodies (ANAs) are essential for diagnosing autoimmune diseases, mainly systemic lupus erythematosus (SLE). This study aimed to compare the performance of two detection methods, chemiluminescence assay (CLIA) and line immunoassay (LIA), in identifying ANAs in patients with autoimmune diseases. The objective was to assess their diagnostic accuracy for SLE and develop a new model using CLIA-detected antibodies specific to SLE.

Research motivation

The motivation behind this research was to improve the diagnosis of SLE, an autoimmune disease, by comparing two detection methods for ANAs. The CLIA and LIA were evaluated for their performance and diagnostic accuracy in detecting ANAs. By developing a novel diagnostic model using CLIA-detected antibodies, the researchers aimed to provide innovative approaches for SLE diagnosis. The study sought to contribute valuable insights into ANA detection and advance strategies for improving the diagnosis of SLE, thus benefiting patients with autoimmune diseases.

Research objectives

The research objectives were to compare the performance of CLIA and LIA in detecting ANAs in patients with autoimmune diseases. The study aimed to assess the diagnostic accuracy of CLIA and LIA for SLE and develop a novel diagnostic model using CLIA-detected antibodies specifically for SLE. Specimens from patients with autoimmune diseases and physical examination specimens were collected to parallel detect specific antibodies. The research focused on evaluating the diagnostic performance of individual antibodies and constructing a diagnostic model combining multiple antibodies. The findings aimed to provide valuable insights into improving SLE diagnosis through innovative approaches and contribute to the development of novel strategies for diagnosing SLE.

Research methods

In this study, specimens from 270 patients with autoimmune diseases and 130 physical examination specimens were collected. The detection of specific antibodies, including anti-double-stranded DNA (dsDNA) antibody, anti-histone antibody, anti-nucleosome antibody, anti-Smith antibody, anti-ribosomal P protein antibody, anti-sicca syndrome A (Ro60) antibody, anti-sicca syndrome A (Ro52) antibody, anti-sicca syndrome (SSB) antibody, anti-centromere protein B (Cenp-B) antibody, anti-DNA topoisomerase 1 (Scl-70) antibody, anti-histidyl tRNA synthetase (Jo-1) antibody, and anti-mitochondrial M2 (AMA-M2) antibody, was performed using CLIA and LIA. The study compared the detection rates, compliance rates, and diagnostic performance for SLE between CLIA and LIA. Furthermore, a novel diagnostic model for SLE was developed based on the results. The agreement between CLIA and LIA in detecting the ANA profiles was assessed, and the diagnostic performance of individual antibodies and the diagnostic model combining multiple antibodies were evaluated using receiver operating characteristics (ROC) analysis.

Research results

The results showed that CLIA and LIA had similar detection rates in detecting ANAs. For a variety of antibodies, including anti-dsDNA antibodies, anti-histone antibodies, anti-Nucleosome antibodies, anti-Smith antibodies, anti-Ribosome P protein antibody, anti-Sjogren's syndrome A (Ro60) antibody, anti-Sjogren's syndrome A (Ro52) antibody, anti-Sjogren's syndrome (SSB) antibody, anti centromeric protein B (Cenp-B) antibody, anti-DNA Topoisomerase 1 (Scl-70) antibody The detection results of anti-Histidine tRNA synthetase (Jo-1) antibody and AMA-M2 antibody are entirely consistent (Kappa > 0.7, P < 0.05). Still, there is moderate consistency in the detection of anti-Ribosome P protein antibody and anti-Histidine tRNA synthetase (Jo-1) antibody (Kappa = 0.671 and 0.665; P < 0.05). In addition, the diagnostic performance of the two methods for SLE is similar. The diagnostic model constructed by chemiluminescence detection of anti-dsDNA antibodies and anti-Ro60 antibodies showed superior diagnostic performance compared to a single antibody after receiving a working ROC analysis, with a curve under area of 0.997, sensitivity of 0.962, and specificity of 0.978. These results indicate that CLIA and the developed diagnostic model can effectively improve the diagnostic level of SLE and provide innovative strategies for improving detection.

Research conclusions

CLIA and LIA perform similarly in detecting ANAs in patients with autoimmune diseases. The two methods were consistent for most tested antibodies, indicating their reliability in diagnosing SLE. In addition, diagnostic models constructed using antibodies detected by CLIA, particularly anti-dsDNA antibodies and anti-Ro60 antibodies, showed superior diagnostic performance compared to single antibodies. These results indicate that CLIA and the developed diagnostic models can promote the improvement of the diagnostic level of SLE and provide innovative strategies for improving detection.

Research perspectives

This study compared ANAs detection methods for autoimmune diseases and evaluated their accuracy in diagnosing SLE. The results showed that CLIA and LIA had similar effects on detecting most antibodies, especially for anti-dsDNA and anti-Ro60 antibodies. In addition, the diagnostic model constructed using antibodies detected by CLIA outperforms the detection of a single antibody in diagnosing SLE. These findings provide valuable insights for improving the diagnosis of SLE through innovative methods. Overall, this study indicates that CLIA and the developed diagnostic models have the potential to diagnose SLE, providing new ideas for improving SLE detection strategies.