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Updated: Feb 27, 2026

Rapid Detection of Fecal Antigen of Helicobacter pylori Infection Based on Double Antibody Sandwich Detection Technology
Published on: May 23, 2025
A one-step immune-chromatographic Helicobacter pylori stool antigen test for children was quick, consistent, reliable
Nicolas Kalach1,2, Pierre Gosset3, Eric Dehecq4
1Clinique Pédiatrique St Antoine, Hôpital St Vincent de Paul, Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL), Lille, France.
Insights
A quick stool antigen test reliably detects Helicobacter pylori (H. pylori) infections in children. This noninvasive method demonstrated high accuracy, making it a valuable diagnostic tool for pediatric H. pylori detection.
Area of Science:
- Pediatric Gastroenterology
- Infectious Diseases
- Diagnostic Microbiology
Background:
- Helicobacter pylori (H. pylori) infection is a common cause of pediatric digestive issues.
- Accurate and noninvasive diagnostic methods are crucial for managing H. pylori in children.
Purpose of the Study:
- To evaluate the accuracy and reliability of a rapid, noninvasive, immuno-chromatographic H. pylori stool antigen test in children.
- To compare the H. pylori stool antigen test results against established reference diagnostic methods.
Main Methods:
- 158 children with symptoms suggestive of upper gastrointestinal disease were enrolled.
- Upper digestive endoscopy with gastric biopsies was performed for reference testing (histology, rapid urease, culture, qPCR).
- The H. pylori stool antigen test was administered twice to each child and compared to reference results.
Main Results:
- H. pylori infection was confirmed in 14.6% (23/158) of the children by reference methods.
- The H. pylori stool antigen test exhibited 91.3% sensitivity and 97% specificity.
- Overall test accuracy was 96.2%, with excellent inter-observer agreement (Kappa=1).
Conclusions:
- The H. pylori stool antigen test is a consistent, reliable, and specific diagnostic tool for H. pylori infection in pediatric patients.
- Its noninvasive nature and high accuracy support its use in clinical settings for children.
- This test offers a valuable alternative for diagnosing H. pylori in pediatric populations.
Aim:
This French study assessed a quick, noninvasive, immuno-chromatographic, Helicobacter pylori (H. pylori) stool antigen test for detecting infections in children.
Methods:
We enrolled 158 children, with a median age of 8.5 years (range eight months to 17 years), with digestive symptoms suggesting upper gastrointestinal tract disease. Upper digestive endoscopy was performed with gastric biopsy specimens for histology, a rapid urease test, culture test and quantitative real-time polymerase chain reaction. The H. pylori stool antigen test was performed twice for each child and the results were compared to the reference method.
Results:
The reference methods showed that 23 (14.6%) of the 158 children tested were H. pylori positive. The H. pylori stool antigen test showed 91.3% sensitivity, with a 95% confidence interval (95% CI) of 86.9-95.6 and 97% specificity (95% CI 94.3-99.6), 30.84 positive likelihood ratio and 0.09 negative likelihood ratio. The test accuracy was 96.2% (95% CI 93.2-99.1). The two blinded independent observers produced identical H. pylori stool antigen test results and the Kappa coefficient for the H. pylori stool antigen test was one.
Conclusion:
The H. pylori stool antigen test was found to be a consistent, reliable, quick and specific test for detecting the H. pylori infection in children.

