Overall and Stratified Accuracies of H. pylori Serology Testing: A Multicenter Study of 8497 Screening-Naïve Adults

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-09-21 DOI:10.1111/hel.70074

Mei-Jyh Chen, Yu-Jen Fang, Chien-Chuan Chen, Chieh-Chang Chen, Jiing-Chyuan Luo, Ming-Jong Bair, Po-Yueh Chen, Chu-Kuang Chou, Ji-Yuh Lee, Tsung-Hua Yang, Jian-Jyun Yu, Chia-Chi Kuo, Min-Chin Chiu, Chi-Yi Chen, Chia-Tung Shun, Wen-Hao Hu, Min-Horn Tsai, Yao-Chun Hsu, Cheng-Hao Tseng, Chi-Yang Chang, Jaw-Town Lin, Emad M. El-Omar, Yi-Chia Lee, Ming-Shiang Wu, Jyh-Ming Liou, the Taiwan Gastrointestinal Disease and Helicobacter Consortium

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引用次数: 0

Abstract

Background

Population-based Helicobacter pylori screening is a promising strategy for gastric cancer prevention in high-prevalence regions. Although serology is recommended for treatment-naïve individuals, its accuracy in large-scale screening remains uncertain. This multicenter study evaluated serology against biopsy-based tests and assessed the influence of age and atrophic status to inform stratified screening policies.

Materials and Methods

In this multicenter diagnostic study, 8497 treatment-naïve adults undergoing upper endoscopy across nine hospitals in Taiwan were tested for H. pylori using serology, rapid urease test (RUT), histology, and culture. Serum pepsinogen I and II levels were measured to define serological atrophic gastritis (AG). Diagnostic performance was assessed against a composite reference standard (≥ 2 positive results among RUT, histology, and culture), with subgroup analyses by age and AG status.

Results

Serology showed a sensitivity of 94.5% (95% CI: 93.7–95.4) and specificity of 86.0% (95% CI: 85.0–87.0), with a diagnostic odds ratio (DOR) of 106.4. RUT, histology, and culture had higher specificities (97.1%, 94.3%, and 98.2%, respectively) but lower sensitivities (88.6%, 92.3%, and 90.2%, respectively). In individuals aged ≤ 45 years, serology demonstrated 95.2% sensitivity, 93.1% specificity, and a DOR of 268.9 (95% CI: 183.4–394.3). Among participants with AG, serologic specificity declined to 62.4% (95% CI: 53.3–71.5) versus 87.2% (95% CI: 86.0–88.5) in those without AG. The overall negative likelihood ratio was 0.06, and 0.05 among younger adults.

Conclusions

Serology is an accurate, non-invasive tool for H. pylori detection in younger, treatment-naïve adults without gastric atrophy in high-prevalence regions. In older individuals or those with atrophic gastritis, confirmatory testing is warranted, supporting age-atrophy–based algorithms to optimize screening strategies.

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幽门螺杆菌血清学检测的整体和分层准确性：一项8497 Screening-Naïve成人的多中心研究

背景：以人群为基础的幽门螺杆菌筛查是高流行地区预防胃癌的一种很有前景的策略。虽然建议对treatment-naïve个体进行血清学检查，但其在大规模筛查中的准确性仍不确定。这项多中心研究评估了血清学和基于活检的检查，并评估了年龄和萎缩状态的影响，为分层筛查政策提供信息。材料与方法本研究以台湾9家医院的8497名成人（treatment-naïve）为研究对象，采用血清学、快速脲酶试验（RUT）、组织学及培养检测幽门螺杆菌。测定血清胃蛋白酶原I和II水平以确定血清学萎缩性胃炎（AG）。根据综合参考标准（RUT、组织学和培养≥2例阳性结果）评估诊断效果，并根据年龄和AG状态进行亚组分析。结果血清学敏感性为94.5% (95% CI: 93.7 ~ 95.4)，特异性为86.0% (95% CI: 85.0 ~ 87.0)，诊断优势比（DOR）为106.4。RUT、组织学和培养具有较高的特异性（分别为97.1%、94.3%和98.2%），但敏感性较低（分别为88.6%、92.3%和90.2%）。在年龄≤45岁的个体中，血清学显示95.2%的敏感性，93.1%的特异性，DOR为268.9 （95% CI: 183.4-394.3）。在患有AG的参与者中，血清学特异性下降到62.4% (95% CI: 53.3-71.5)，而在没有AG的参与者中，血清学特异性下降到87.2% （95% CI: 86.0-88.5）。总体负似然比为0.06，在年轻人中为0.05。结论血清学是一种准确、无创的幽门螺杆菌检测工具，适用于高流行地区年轻、treatment-naïve无胃萎缩的成年人。在老年人或萎缩性胃炎患者中，验证性测试是必要的，支持基于年龄萎缩的算法来优化筛查策略。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Helicobacter 医学-微生物学

CiteScore

8.40

自引率

9.10%

发文量

审稿时长

2 months

期刊介绍： Helicobacter is edited by Professor David Y Graham. The editorial and peer review process is an independent process. Whenever there is a conflict of interest, the editor and editorial board will declare their interests and affiliations. Helicobacter recognises the critical role that has been established for Helicobacter pylori in peptic ulcer, gastric adenocarcinoma, and primary gastric lymphoma. As new helicobacter species are now regularly being discovered, Helicobacter covers the entire range of helicobacter research, increasing communication among the fields of gastroenterology; microbiology; vaccine development; laboratory animal science.