Utility of stool sample-based tests for the diagnosis of Helicobacter pylori infection in children
Related Experiment Video
Updated: Jun 2, 2026

Rapid Detection of Fecal Antigen of Helicobacter pylori Infection Based on Double Antibody Sandwich Detection Technology
Published on: May 23, 2025
Yelda A Leal1, Roberto Cedillo-Rivera, J Abraham Simón
1Unidad de Investigación Médica Yucatán (UIMY), Unidad Médica de Alta Especialidad de Mérida, Instituto Mexicano del Seguro Social, Mérida, Yucatan, México. yelda_leal03@yahoo.com.mx
Insights
Enzyme-linked immunosorbent assay (ELISA) monoclonal antibody stool tests are effective for diagnosing Helicobacter pylori infection in children. Other stool tests, including one-step and molecular assays, show lower accuracy and require further development.
Area of Science:
- Pediatric Gastroenterology
- Infectious Diseases
- Diagnostic Accuracy Studies
Background:
- Helicobacter pylori infection is common globally, but diagnosis in children can be challenging due to variable fecal antigen/DNA shedding.
- Accurate, noninvasive diagnostic methods are crucial for effective pediatric H. pylori management.
Purpose of the Study:
- To systematically review and meta-analyze the performance of stool-based H. pylori antigen and DNA tests in children.
- To identify the most accurate noninvasive diagnostic methods for H. pylori infection in pediatric populations.
Main Methods:
- A systematic review and meta-analysis of studies published in PubMed, EMBASE, and LILACS databases.
- Inclusion criteria required at least 30 pediatric participants and a gold standard H. pylori diagnostic method.
- 48 studies were identified and included in the comprehensive analysis.
Main Results:
- ELISA monoclonal antibody tests demonstrated high accuracy (97% sensitivity, 97% specificity, LR+ 29.9).
- ELISA polyclonal antibody and one-step monoclonal antibody tests showed moderate accuracy with significant heterogeneity.
- Polymerase chain reaction (PCR)-based DNA tests offered high specificity (98%) but lower sensitivity (80.8%).
Conclusions:
- Stool ELISA testing using monoclonal antibodies is a highly accurate and efficient noninvasive method for diagnosing H. pylori infection in children.
- One-step stool tests and current molecular diagnostic tests exhibit limitations in accuracy and require further research for clinical utility.
Objective:
Helicobacter pylori antigen or DNA in stool are meant to detect the bacteria; however, in children the colonization of the gastric mucosa by H pylori is usually weak and fecal excretion of antigen or DNA varies considerably, challenging the utility of these tests in this age group. The aim of the present study was to carry out a systematic review and meta-analysis to evaluate the performance of stool H pylori DNA and antigen tests for the diagnosis of infection in children.
Methods:
We conducted a systematic review and meta-analysis to assess the accuracy of stool tests for diagnosis of H pylori infection in children. We searched PubMed, EMBASE, and LILACS databases. Selection criteria included participation of at least 30 children and the use of a criterion standard for H pylori diagnosis. In a comprehensive search, we identified 48 studies.
Results:
Regarding antigen-detection tests, enzyme-linked immunosorbent assay (ELISA) monoclonal antibodies showed the best performance, with sensitivity and specificity of 97%, positive likelihood ratio (LR+) of 29.9, and negative likelihood ratio (LR-) of 0.03. ELISA polyclonal antibodies had sensitivity of 92%, specificity of 93%, LR+ of 16.2, LR- of 0.09, and high heterogeneity (P < 0.0001). One-step monoclonal antibody tests demonstrated sensitivity of 88%, specificity of 93%, LR+ of 10.6, and LR- of 0.11. For DNA detection, polymerase chain reaction-based test showed sensitivity of 80.8%, specificity of 98%, LR+ of 17.1, and LR- of 0.18.
Conclusions:
Detection of H pylori antigen in stools with ELISA monoclonal antibodies is a noninvasive efficient test for diagnosis of infection in children. One-step tests showed low accuracy and more studies are needed to obtain a useful office-based screening test. The available molecular tests are still unreliable.
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