Evaluation of a novel chemiluminescent immunoassay for autoantibody detection in pemphigus and bullous pemphigoid

BackgroundA 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 dia...

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Main Authors: Na Zhang, Ming Wang, Lili Hou, Yanyu Zhang, Yan Zhao, Luyang Du, Xiaoqing Li, Xia Liu, Hongwei Zhou, Jiaxuan Hao, Jing Tian, Qiuping Yu, Lixia Li, Fangming Cheng, Hai-Zhou Zhou
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Language:English
Published: Frontiers Media S.A. 2025-06-01
Series:Frontiers in Immunology
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Online Access:https://www.frontiersin.org/articles/10.3389/fimmu.2025.1576635/full
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author Na Zhang
Ming Wang
Lili Hou
Yanyu Zhang
Yan Zhao
Luyang Du
Xiaoqing Li
Xia Liu
Hongwei Zhou
Jiaxuan Hao
Jing Tian
Qiuping Yu
Lixia Li
Fangming Cheng
Hai-Zhou Zhou
author_facet Na Zhang
Ming Wang
Lili Hou
Yanyu Zhang
Yan Zhao
Luyang Du
Xiaoqing Li
Xia Liu
Hongwei Zhou
Jiaxuan Hao
Jing Tian
Qiuping Yu
Lixia Li
Fangming Cheng
Hai-Zhou Zhou
author_sort Na Zhang
collection DOAJ
description BackgroundA 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.MethodsSera 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.ResultsThis 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.ConclusionsThe 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.
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spelling doaj-art-3dbcc2591c8244eaa5c46519c3fc4a702025-08-20T02:40:35ZengFrontiers Media S.A.Frontiers in Immunology1664-32242025-06-011610.3389/fimmu.2025.15766351576635Evaluation of a novel chemiluminescent immunoassay for autoantibody detection in pemphigus and bullous pemphigoidNa Zhang0Ming Wang1Lili Hou2Yanyu Zhang3Yan Zhao4Luyang Du5Xiaoqing Li6Xia Liu7Hongwei Zhou8Jiaxuan Hao9Jing Tian10Qiuping Yu11Lixia Li12Fangming Cheng13Hai-Zhou Zhou14Department of Laboratory Diagnostics, The First Affiliated Hospital of Harbin Medical University, Harbin, ChinaGlobal Academic Department, Shenzhen YHLO Biotech Co., Ltd, Shenzhen, Guangdong, ChinaDepartment of Laboratory Diagnostics, The First Affiliated Hospital of Harbin Medical University, Harbin, ChinaDepartment of Laboratory Diagnostics, The First Affiliated Hospital of Harbin Medical University, Harbin, ChinaDepartment of Laboratory Diagnostics, The First Affiliated Hospital of Harbin Medical University, Harbin, ChinaGlobal Academic Department, Shenzhen YHLO Biotech Co., Ltd, Shenzhen, Guangdong, ChinaDepartment of Laboratory Diagnostics, The First Affiliated Hospital of Harbin Medical University, Harbin, ChinaDepartment of Laboratory Diagnostics, The First Affiliated Hospital of Harbin Medical University, Harbin, ChinaDepartment of Laboratory Diagnostics, The First Affiliated Hospital of Harbin Medical University, Harbin, ChinaDepartment of Laboratory Diagnostics, The First Affiliated Hospital of Harbin Medical University, Harbin, ChinaDermatology, The First Affiliated Hospital of Harbin Medical University, Harbin, ChinaGlobal Academic Department, Shenzhen YHLO Biotech Co., Ltd, Shenzhen, Guangdong, ChinaGlobal Academic Department, Shenzhen YHLO Biotech Co., Ltd, Shenzhen, Guangdong, ChinaReagent R&D Center, Shenzhen YHLO Biotech Co., Ltd, Shenzhen, Guangdong, ChinaDepartment of Laboratory Diagnostics, The First Affiliated Hospital of Harbin Medical University, Harbin, ChinaBackgroundA 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.MethodsSera 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.ResultsThis 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.ConclusionsThe 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.https://www.frontiersin.org/articles/10.3389/fimmu.2025.1576635/fullpemphigusbullous pemphigoiddesmogleinBP180BP230chemiluminescent immunoassay
spellingShingle Na Zhang
Ming Wang
Lili Hou
Yanyu Zhang
Yan Zhao
Luyang Du
Xiaoqing Li
Xia Liu
Hongwei Zhou
Jiaxuan Hao
Jing Tian
Qiuping Yu
Lixia Li
Fangming Cheng
Hai-Zhou Zhou
Evaluation of a novel chemiluminescent immunoassay for autoantibody detection in pemphigus and bullous pemphigoid
Frontiers in Immunology
pemphigus
bullous pemphigoid
desmoglein
BP180
BP230
chemiluminescent immunoassay
title Evaluation of a novel chemiluminescent immunoassay for autoantibody detection in pemphigus and bullous pemphigoid
title_full Evaluation of a novel chemiluminescent immunoassay for autoantibody detection in pemphigus and bullous pemphigoid
title_fullStr Evaluation of a novel chemiluminescent immunoassay for autoantibody detection in pemphigus and bullous pemphigoid
title_full_unstemmed Evaluation of a novel chemiluminescent immunoassay for autoantibody detection in pemphigus and bullous pemphigoid
title_short Evaluation of a novel chemiluminescent immunoassay for autoantibody detection in pemphigus and bullous pemphigoid
title_sort evaluation of a novel chemiluminescent immunoassay for autoantibody detection in pemphigus and bullous pemphigoid
topic pemphigus
bullous pemphigoid
desmoglein
BP180
BP230
chemiluminescent immunoassay
url https://www.frontiersin.org/articles/10.3389/fimmu.2025.1576635/full
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