METHODS article

Front. Immunol.

Sec. Autoimmune and Autoinflammatory Disorders : Autoimmune Disorders

Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1576635

This article is part of the Research TopicThe pathogenesis and novel treatment options in AIBDsView all 4 articles

Evaluation of a Novel Chemiluminescent Immunoassay for Autoantibody Detection in Pemphigus and Bullous Pemphigoid

Provisionally accepted
Na  ZhangNa Zhang1Ming  WangMing Wang2Li-Li  HouLi-Li Hou1Yan-Yu  ZhangYan-Yu Zhang1Yan  ZhaoYan Zhao1Lu-Yang  DuLu-Yang Du3Xiao-Qing  LiXiao-Qing Li1Xia  LiuXia Liu1宏伟  Hongwei宏伟 Hongwei1Jia-Xuan  HaoJia-Xuan Hao1Jing  TianJing Tian1Qiu-Ping  YuQiu-Ping Yu1Hai-Zhou  ZhouHai-Zhou Zhou1*
  • 1First Affiliated Hospital of Harbin Medical University, Harbin, China
  • 2Department of Pathology, Faculty of Biology, School of Biological Sciences, University of Cambridge, Cambridge, England, United Kingdom
  • 3Shenzhen YHLO Biotech Co., Ltd, Shenzhen, Guangdong, 518116, China, GUANG ZHOU, China

The final, formatted version of the article will be published soon.

Background: A novel fully automated chemiluminescent immunoassay (CLIA) has been developed to quantify autoantibodies specific for desmogleins (Dsg1, Dsg3), BP180, and BP230, key target antigens in pemphigus and bullous pemphigoid. This study aims to evaluate the diagnostic accuracy of the CLIA in diagnosing pemphigus and BP and its correlation with disease severity and clinical features.Methods: Sera from 106 bullous pemphigoid and 54 pemphigus patients and control sera from 153 patients with other skin disease and 121 healthy volunteers were included. CLIA and BIOCHIP mosaic-based indirect immunofluorescence (IIFT-BIOCHIP) were performed for all bullous pemphigoid and pemphigus patients, with ELISA conducted for most. Disease severity was assessed using the Body Surface Area scoring.Results: This CLIA showed strong agreement with IIFT-BIOCHIP, achieving area under the curve (AUC) values of 0.92 for anti-Dsg1/anti-Dsg3 and 0.84 for anti-BP180/anti-BP230 for differentiating pemphigus and BP. It outperformed ELISA (AUC: 0.73, 0.75) and was comparable to IIFT-BIOCHIP (AUC: 0.93, 0.87). The assay showed superior detection range and sensitivity compared to ELISA. Autoantibody levels correlated with disease severity and clinical symptoms, with elevated levels of anti-Dsg3 associated with mucosal lesions, anti-Dsg1/anti-Dsg3 associated with Nikolsky sign, and elevated anti-BP180/anti-BP230 levels linked to pruritus. Conclusions: The novel CLIA, the first to quantify four major autoimmune blister disease autoantibodies (anti-Dsg1/anti-Dsg3/anti-BP180/anti-BP230) using a single sample tube, offers a simple and time-efficient test for diagnosing and screening pemphigus and BP. Its ability to assess disease severity and clinical relevance makes it a valuable tool for managing these conditions.

Keywords: Pemphigus1, Bullous Pemphigoid2, Desmoglein3, BP1804, BP2305, Chemiluminescent Immunoassay6

Received: 14 Feb 2025; Accepted: 13 Jun 2025.

Copyright: © 2025 Zhang, Wang, Hou, Zhang, Zhao, Du, Li, Liu, Hongwei, Hao, Tian, Yu and Zhou. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Hai-Zhou Zhou, First Affiliated Hospital of Harbin Medical University, Harbin, China

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