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Rapid Detection of Fecal Antigen of Helicobacter pylori Infection Based on Double Antibody Sandwich Detection Technology
Published on: May 23, 2025
Stool antigen tests for the detection of Helicobacter pylori in children
Abolfazl Iranikhah1, Mohammad-Reza Ghadir, Saeed Sarkeshikian
1Department of Pediatric Gastroenterology, Qom University of Medical Sciences, Qom, Iran.
Insights
The stool antigen test is a reliable, non-invasive method for detecting Helicobacter pylori (H. pylori) infection in children with abdominal pain. This rapid diagnostic technique shows high sensitivity and specificity, potentially replacing invasive endoscopy.
Area of Science:
- Pediatric Gastroenterology
- Infectious Diseases
- Diagnostic Accuracy Studies
Background:
- Reliable non-invasive methods are needed for childhood Helicobacter pylori (H. pylori) detection.
- Stool antigen tests offer a non-invasive alternative, but their accuracy in developing countries requires evaluation.
- This study focuses on H. pylori diagnosis in Iranian children with recurrent abdominal pain.
Purpose of the Study:
- To evaluate the performance of the H. pylori stool antigen (HpSA) test in Iranian children.
- To determine the accuracy of HpSA compared to endoscopy and biopsy.
- To assess the utility of HpSA as a diagnostic tool for H. pylori infection in pediatric patients.
Main Methods:
- 103 children with recurrent abdominal pain underwent endoscopy and biopsy.
- H. pylori stool antigen (HpSA) tests were performed using enzyme-linked immunosorbent assay.
- Sensitivity, specificity, and likelihood ratios of HpSA were calculated against gastric biopsy cultures.
Main Results:
- H. pylori infection was detected in 39.8% by biopsy and 37.8% by HpSA.
- The HpSA test demonstrated a sensitivity of 85% and specificity of 93%.
- Positive and negative likelihood ratios for HpSA were 89.7% and 90%, respectively.
Conclusions:
- The H. pylori stool antigen test is a sensitive and specific, low-cost diagnostic method for children.
- HpSA can effectively replace endoscopy and biopsy for H. pylori detection in this pediatric population.
- Results are comparable to international findings, supporting HpSA's use in clinical settings.
Objective:
Reliable non-invasive methods for detection of Helicobacter pylori (H. pylori) infection are required to investigate the incidence, transmission, and clearance of infection in childhood. Detecting bacterial antigens in stool offer an alternative noninvasive diagnostic test. However its accuracy in developing countries is not well established. The aim of this study was to evaluate the performance of stool antigen test for H pylori in Iranian children with recurrent abdominal pain necessitating endoscopy.
Methods:
One hundred three children enrolled in this study. Endoscopy and biopsy was done on all patients providing a criterion standard for validation of the H. pylori stool antigen (HpSA) tests. The presence of H. pylori organisms in stool was determined by an enzyme-linked immunosorbent assay using a commercially available polyclonal antibody. HpSA sensitivity, specificity, and positive and negative likelihood ratios were determined with reference to the results of cultures of gastric biopsy.
Findings:
Of the 103 children tested 41 (39.8%) and 39 (37.8%) were positive for H. pylori according to the results of cultures of gastric biopsy and HpSA, respectively. The sensitivity, specificity, and positive and negative likelihood ratios of HpSA were found to be 85%, 93%, 89.7%, and 90%, respectively.
Conclusion:
In this pilot study, a low-cost and rapid diagnostic technique, stool antigen test proved to be highly sensitive and specific for detecting H pylori infection in children with recurrent abdominal pain. Our results are comparable to those reported elsewhere in children and demonstrate that the HpSA test can replace endoscopy and biopsy for detecting H. pylori infection.
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