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同时使用IgA组织转谷氨酰胺酶和IgG-脱酰胺麦醇溶蛋白肽抗体可在不进行十二指肠活检的情况下准确诊断乳糜泻。

Utilizing both IgA tissue transglutaminase and IgG-deamidated gliadin peptide antibodies offers accurate celiac disease diagnosis without duodenal biopsy.

作者信息

Zingone Fabiana, Norman Gary L, Smecuol Edgardo, Maniero Daria, Carroccio Antonio, Biagi Federico, Stefanolo Juan P, Niveloni Sonia, Holmes Geoffrey, Villanacci Vincenzo, Santonicola Antonella, Bai Julio C, Ciacci Carolina

机构信息

Department of Surgery, Oncology, Gastroenterology, University of Padua, Padua, Italy; Gastroenterology Unit, Azienda Ospedale Università di Padova, Padua, Italy.

Research and Development, Headquarters & Technology Center Autoimmunity, Werfen, San Diego, CA, USA.

出版信息

Dig Liver Dis. 2025 Feb;57(2):609-615. doi: 10.1016/j.dld.2024.10.010. Epub 2024 Oct 29.

Abstract

BACKGROUND

Gastroenterologists still raise concerns about adopting a non-biopsy strategy for diagnosing celiac disease (CeD) in adults.

AIM

To assess the performance of the concurrent detection of two autoantibodies targeting two independent antigens, tissue transglutaminase (tTG) and deamidated gliadin peptides (DGP).

METHODS

This prospective, multicenter, binational study collected consecutive patients with a high pre-test probability for CeD. Between 2018 and 2020, adults were enrolled at four Italian and one Argentinian center. Serology was also blindly analyzed by a central laboratory (Werfen, San Diego, USA) for tTG IgA and DGP IgG by Aptiva Particle-based multi-analyte technology (PMAT) assays. CeD diagnosis required histological confirmation of Marsh 3 damage.

RESULTS

181 adult patients with suspected CeD were enrolled (134 with histological diagnosis of CeD and 47 not histologically confirmed as CeD). Patients positive for both tTG IgA and DGP IgG (double positive) were predictive of CeD in 92.5 % of patients at >1x upper limit of normal (ULN). Double positivity for tTG IgA and DGP IgG, both at >10x ULN, had a 100 % positive predictive value for the presence of Marsh 3 histology.

CONCLUSIONS

Incorporating DGP IgG alongside tTG IgA in a single-step approach can be considered a valid confirmatory strategy for definitive non-biopsy diagnosis of CeD.

摘要

背景

胃肠病学家对于在成人乳糜泻(CeD)诊断中采用非活检策略仍存在担忧。

目的

评估同时检测针对两种独立抗原的两种自身抗体,即组织转谷氨酰胺酶(tTG)和去酰胺化麦醇溶蛋白肽(DGP)的性能。

方法

这项前瞻性、多中心、双边研究收集了CeD预测试概率高的连续患者。2018年至2020年期间,在四个意大利中心和一个阿根廷中心招募了成年人。血清学检测也由一个中央实验室(美国圣地亚哥的Werfen公司)采用基于Aptiva颗粒的多分析物技术(PMAT)检测tTG IgA和DGP IgG,检测过程为盲法。CeD诊断需要Marsh 3损伤的组织学确认。

结果

共纳入181例疑似CeD的成年患者(134例经组织学诊断为CeD,47例未得到组织学确诊)。tTG IgA和DGP IgG均呈阳性(双阳性)的患者在超过正常上限(ULN)1倍以上时,对CeD的预测准确率为92.5%。tTG IgA和DGP IgG均超过10倍ULN时的双阳性对存在Marsh 3组织学表现的阳性预测值为100%。

结论

在单一检测步骤中将DGP IgG与tTG IgA结合使用,可被视为CeD最终非活检诊断的有效确认策略。

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