Diagnostic potential of non-invasive tests for Helicobacter pylori-associated gastroduodenal disease in a resource-limited laboratory setting

IF 1.8 4区医学 Q3 INFECTIOUS DISEASES

Diagnostic microbiology and infectious disease Pub Date : 2026-02-01 Epub Date: 2025-10-27 DOI:10.1016/j.diagmicrobio.2025.117167

Maryam Gasimova , Akif Gurbanov , Agigat Kadyrova , Ravil Huseynov , Vidadi Narimanov

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引用次数: 0

Abstract

Background

In resource-limited laboratory settings non-invasive diagnostics are essential for Helicobacter pylori detection, yet their accuracy varies with disease severity. This study aimed to evaluate diagnostic potential of two widely available non-invasive diagnostic methods - serological antibody (Ab) detection and lateral flow stool-antigen testing (HpSAT) - for their ability both to detect and to differentiate H. pylori-associated gastroduodenal disorders.

Methods

A total of 128 symptomatic patients (98 with gastritis and 30 with stomach/duodenal ulcer) were enrolled. All underwent ELISA-IgG, rapid Ab test and HpSAT; 17 ulcer patients additionally had a biopsy rapid-urease test (RUT). Per-index composite reference standard (CRS) was established to define infection status. As a no-gold-standard sensitivity analysis, we implemented a Bayesian latent class model (LCM) with local dependence between ELISA and Rapid Ab test.

Results

Under the CRS, ELISA had sensitivity 98.2 % and specificity 62.5 %; Rapid Ab test had 91.2 % and 53.6 %; HpSAT had 63.5 % and 75.0 %. For ulcer vs. gastritis discrimination in the full cohort, HpSAT had the highest overall accuracy (65.6 %) via balanced sensitivity (76.7 %) and higher specificity (62.2 %). Bayesian LCM estimated Se/Sp as: ELISA Se/Sp 64.6 %/80.9 %; Rapid Ab 91.7 %/63.8 %; HpSAT 94.8 % /74.2 %).

Conclusions

HpSAT showed the most balanced non-invasive performance for detecting active H. pylori and the strongest discrimination of ulcer versus gastritis. Where urease breath testing (UBT) is unavailable, a tiered approach—HpSAT first-line for suspected active infection/ulceration, with serology as adjunct appears pragmatic. Prospective studies using a uniform reference standard are needed.

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在资源有限的实验室环境中，幽门螺杆菌相关胃十二指肠疾病的无创检测诊断潜力

背景：在资源有限的实验室环境中，非侵入性诊断对幽门螺杆菌检测至关重要，但其准确性因疾病严重程度而异。本研究旨在评估两种广泛使用的非侵入性诊断方法——血清学抗体（Ab）检测和侧流粪便抗原检测（HpSAT）——的诊断潜力，因为它们能够检测和区分幽门螺杆菌相关的胃十二指肠疾病。方法：共纳入128例有症状的患者，其中胃炎98例，胃/十二指肠溃疡30例。所有患者均行ELISA-IgG、快速Ab和HpSAT检测；17例溃疡患者另外进行了活检快速脲酶试验（RUT）。建立按指标综合参考标准（CRS）来定义感染状态。作为无金标准敏感性分析，我们在ELISA和快速抗体检测之间建立了局部依赖的贝叶斯潜类模型（LCM）。结果：在CRS条件下，ELISA的敏感性为98.2%，特异性为62.5%；快速Ab试验分别为91.2%和53.6%；HpSAT分别为63.5%和75.0%。在整个队列中，对于溃疡和胃炎的区分，HpSAT通过平衡敏感性（76.7%）和更高的特异性（62.2%）具有最高的总体准确性（65.6%）。贝叶斯LCM估计Se/Sp为：ELISA Se/Sp 64.6% / 80.9%；Rapid Ab 91.7% / 63.8%；HpSAT 94.8% / 74.2%)。结论：HpSAT在检测活性幽门螺杆菌方面表现出最平衡的无创性能，对溃疡和胃炎的鉴别能力最强。当脲酶呼吸测试（UBT）不可用时，分层方法- hpsat一线用于疑似活动性感染/溃疡，血清学作为辅助似乎是实用的。需要使用统一参考标准的前瞻性研究。

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

Diagnostic microbiology and infectious disease 医学-传染病学

CiteScore

5.30

自引率

3.40%

发文量

149

审稿时长

56 days

期刊介绍： Diagnostic Microbiology and Infectious Disease keeps you informed of the latest developments in clinical microbiology and the diagnosis and treatment of infectious diseases. Packed with rigorously peer-reviewed articles and studies in bacteriology, immunology, immunoserology, infectious diseases, mycology, parasitology, and virology, the journal examines new procedures, unusual cases, controversial issues, and important new literature. Diagnostic Microbiology and Infectious Disease distinguished independent editorial board, consisting of experts from many medical specialties, ensures you extensive and authoritative coverage.