Luochengling Xiang, Ying Zhou, Xiaopei Guo, Michiel C. Mommersteeg, Stella A. V. Nieuwenburg, Maikel P. Peppelenbosch, Manon C. W. Spaander, Gwenny M. Fuhler
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Patients with gastric premalignant lesions underwent endoscopy, and fasting serum samples were collected for biomarker analysis using both LFA and ELISA.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>A total of 204 patients were included in this study. LFA demonstrated diagnostic specificity for AG comparable to ELISA, with specificity rates of 95.74% (95% CI [85.75%–99.24%]) for LFA and 100.00% (95% CI [92.44%–100.00%]) for ELISA (<i>p</i> = 0.49). Both methods showed similar performance in detecting <i>H. pylori</i> infection, with an AUC of 0.754 (95% CI [0.616–0.891]) for LFA and 0.778 (95% CI [0.633–0.922]) for ELISA (<i>p</i> = 0.70). For identifying autoimmune gastritis in corpus AG, a reduced PGI/PGII ratio combined with elevated G-17 levels provided excellent discrimination, achieving an AUC of 0.926 (95% CI [0.870–0.926]) for LFA and 0.924 (95% CI [0.861–0.924]) for ELISA.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>The LFA assay is a feasible, rapid, and non-invasive tool for assessing gastric functional mucosa. Its diagnostic performance for detecting AG is comparable to ELISA, making it a supplementary tool in point-of-care settings to improve the early detection of AG.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>This study was not registered as a clinical trial, as it is based on an observational study, Progression and Regression of precancerous Gastric Lesions (PROREGAL) study.</p>\n </section>\n </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 4","pages":""},"PeriodicalIF":4.3000,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.70066","citationCount":"0","resultStr":"{\"title\":\"Evaluation of Pepsinogen I, II, Gastrin 17 and Helicobacter pylori IgG in Atrophic Gastritis: A Head-To-Head Comparison of Lateral Flow and Enzyme-Linked Immunosorbent Assays\",\"authors\":\"Luochengling Xiang, Ying Zhou, Xiaopei Guo, Michiel C. 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引用次数: 0
摘要
横向流动试验（LFA）包含了多种生物标志物，包括胃蛋白酶原I （PGI）、胃蛋白酶原II （PGII）、胃泌素-17 （G-17）和幽门螺杆菌IgG，能够快速无创检测萎缩性胃炎（AG）。然而，与传统的酶联免疫吸附试验（ELISA）相比，其诊断性能尚未确定。方法本研究纳入了前瞻性多中心队列。胃癌前病变患者行胃镜检查，并收集空腹血清样本，采用LFA和ELISA进行生物标志物分析。结果本研究共纳入204例患者。LFA对AG的诊断特异性与ELISA相当，LFA的特异性为95.74% (95% CI [85.75% ~ 99.24%])， ELISA的特异性为100.00% (95% CI [92.44% ~ 100.00%]) （p = 0.49）。两种方法检测幽门螺杆菌感染的效果相似，LFA的AUC为0.754 (95% CI [0.616-0.891])， ELISA的AUC为0.778 (95% CI [0.633-0.922]) （p = 0.70）。对于鉴别自身免疫性胃炎，PGI/PGII比值降低结合G-17水平升高提供了很好的鉴别，LFA的AUC为0.926 (95% CI [0.870-0.926])， ELISA的AUC为0.924 （95% CI[0.861-0.924]）。结论LFA法是一种可行、快速、无创的胃粘膜功能评价方法。其检测AG的诊断性能与ELISA相当，使其成为护理点环境中提高AG早期检测的补充工具。这项研究没有注册为临床试验，因为它是基于一项观察性研究，癌前胃病变的进展和消退（PROREGAL）研究。
Evaluation of Pepsinogen I, II, Gastrin 17 and Helicobacter pylori IgG in Atrophic Gastritis: A Head-To-Head Comparison of Lateral Flow and Enzyme-Linked Immunosorbent Assays
Background
A lateral flow assay (LFA) incorporating several biomarkers, including pepsinogen I (PGI), pepsinogen II (PGII), Gastrin-17 (G-17), and Helicobacter pylori IgG, enables the rapid non-invasive detection of atrophic gastritis (AG). However, its diagnostic performance compared to conventional enzyme-linked immunosorbent assay (ELISA) has not been established.
Methods
This head-to-head comparison study included participants from a prospective and multicenter cohort. Patients with gastric premalignant lesions underwent endoscopy, and fasting serum samples were collected for biomarker analysis using both LFA and ELISA.
Results
A total of 204 patients were included in this study. LFA demonstrated diagnostic specificity for AG comparable to ELISA, with specificity rates of 95.74% (95% CI [85.75%–99.24%]) for LFA and 100.00% (95% CI [92.44%–100.00%]) for ELISA (p = 0.49). Both methods showed similar performance in detecting H. pylori infection, with an AUC of 0.754 (95% CI [0.616–0.891]) for LFA and 0.778 (95% CI [0.633–0.922]) for ELISA (p = 0.70). For identifying autoimmune gastritis in corpus AG, a reduced PGI/PGII ratio combined with elevated G-17 levels provided excellent discrimination, achieving an AUC of 0.926 (95% CI [0.870–0.926]) for LFA and 0.924 (95% CI [0.861–0.924]) for ELISA.
Conclusion
The LFA assay is a feasible, rapid, and non-invasive tool for assessing gastric functional mucosa. Its diagnostic performance for detecting AG is comparable to ELISA, making it a supplementary tool in point-of-care settings to improve the early detection of AG.
Trial Registration
This study was not registered as a clinical trial, as it is based on an observational study, Progression and Regression of precancerous Gastric Lesions (PROREGAL) study.
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.
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