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Updated: Feb 28, 2026
Author Spotlight: Detection and Treatment of Helicobacter pylori Infection
Published on: July 28, 2023
Validation of a Gastric-Juice-Analysis-Based Approach to H. pylori Diagnosis
Flavia Pigò1, Gian Carmine Fernicola1, Marinella Lupo1
1Gastroenterology and Digestive Endoscopy Unit, Azienda Ospedaliero-Universitaria of Modena, Viale Giardini 1355, 41126 Modena, Italy.
Abstract:
Background: Although the incidence of H. pylori infection is decreasing globally, it is not completely negligible. Because H. pylori infection is associated with various pathologies, ranging from peptic ulcer disease to neoplastic lesions, research into and treatment of H. pylori infections remain important. Objectives: We aimed to assess the diagnostic performance of gastric juice analysis (Endofaster®) for the detection of H. pylori in patients undergoing esophagogastroduodenoscopy (EGDS), using conventional histology as the reference standard. Our secondary objectives were to identify the optimal ammonium concentration thresholds for defining positive and negative results and to propose a clinical flowchart to support patient management. Methods: The diagnostic accuracy of Endofaster was first analyzed using an unmatched training cohort comprising an equal number of H. pylori-positive patients (n = 30) and negative controls (n = 30) who underwent EGDS. The derived thresholds were subsequently evaluated in an independent validation cohort of patients who underwent EGDS with Endofaster. Histological examination is the gold standard for H. pylori diagnosis. Results: In the training cohort, an ammonium concentration cut-off of 62 ppm/mL yielded a sensitivity of 90% (95% CI: 74-97%) for ruling out H. pylori infection. For confirming infection, the optimal cut-off was 100 ppm/mL, corresponding to a specificity of 95% (95% CI: 83-99%). Ammonium values > 62 and <100 ppm/mL were considered indeterminate, suggesting gastric biopsy was required for confirmation. The validation cohort included 196 patients (mean age: 59.9 ± 12.7 years), with a histology-based H. pylori prevalence of 19%. In this cohort, Endofaster® demonstrated a sensitivity of 70% (95% CI: 51-85%) and a specificity of 93% (95% CI: 88-97%). Indeterminate results were observed for 29 patients (15%). Conclusions: Endofaster® provides a largely reliable diagnosis of H. pylori infection during EGDS when a decision-making approach is applied, allowing gastric biopsies to be reserved for indeterminate cases only.
Insights
Gastric juice analysis using Endofaster® offers a reliable method for diagnosing Helicobacter pylori (H. pylori) infection during esophagogastroduodenoscopy (EGDS). This approach helps reserve invasive gastric biopsies for indeterminate cases, improving patient management.
Area of Science:
- Gastroenterology
- Infectious Diseases
- Diagnostic Medicine
Background:
- Helicobacter pylori (H. pylori) infection, though declining, remains a significant concern due to its association with peptic ulcer disease and neoplastic lesions.
- Effective diagnosis and treatment of H. pylori are crucial for preventing associated gastrointestinal pathologies.
- Research into H. pylori remains important despite decreasing global incidence.
Purpose of the Study:
- To evaluate the diagnostic performance of gastric juice analysis via Endofaster® for H. pylori detection during esophagogastroduodenoscopy (EGDS).
- To establish optimal ammonium concentration thresholds for positive and negative H. pylori results using Endofaster®.
- To propose a clinical flowchart for patient management based on Endofaster® results.
Main Methods:
- Diagnostic accuracy of Endofaster® was assessed in a training cohort (n=60) and validated in an independent cohort (n=196) undergoing EGDS.
- Conventional histology served as the gold standard for H. pylori diagnosis in both cohorts.
- Ammonium concentration thresholds were determined to classify results as positive, negative, or indeterminate.
Main Results:
- In the training cohort, cut-offs of 62 ppm/mL (sensitivity 90%) and 100 ppm/mL (specificity 95%) were identified for ruling out and confirming H. pylori infection, respectively.
- The validation cohort showed Endofaster® sensitivity of 70% and specificity of 93% for H. pylori detection.
- Indeterminate results, requiring further confirmation, were observed in 15% of the validation cohort.
Conclusions:
- Endofaster® provides a largely reliable diagnosis of H. pylori infection during EGDS when a decision-making approach is applied.
- This method allows for the selective use of gastric biopsies, reserving them for indeterminate cases.
- The proposed clinical flowchart can support effective patient management for H. pylori infections.
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