Evaluation of two commercially available rapid stool antigen tests for the diagnosis of Helicobacter pylori infection

Mohamed Abd ElAziz Metwally; Hala Mohamed Alfeky; Hatem Samir Alegaily; Azza Hasan Abbas; El Shahat Ahmed El Shahat; Angham Mohamed Abd Elmonem; Hoda Mohamed Rabie Gabal

doi:10.3855/jidc.17525

Evaluation of two commercially available rapid stool antigen tests for the diagnosis of Helicobacter pylori infection

Authors

Mohamed Abd ElAziz Metwally Department of Hepatology, Gastroenterology and Infectious Diseases, Faculty of Medicine, Benha University, Benha, Qalyubiyah, Egypt
Hala Mohamed Alfeky Department of Hepatology, Gastroenterology and Infectious Diseases, Faculty of Medicine, Benha University, Benha, Qalyubiyah, Egypt
Hatem Samir Alegaily Department of Hepatology, Gastroenterology and Infectious Diseases, Faculty of Medicine, Benha University, Benha, Qalyubiyah, Egypt https://orcid.org/0000-0002-5480-5117
Azza Hasan Abbas Parasitology, Microbiology and Molecular Biology Department, National Hepatology and Tropical Medicine Research Institute (NHTMRI), General Organization of Teaching Hospitals and Institutes (GOTHI), Cairo, Egypt https://orcid.org/0000-0003-3218-6922
El Shahat Ahmed El Shahat Parasitology, Microbiology and Molecular Biology Department, National Hepatology and Tropical Medicine Research Institute (NHTMRI), General Organization of Teaching Hospitals and Institutes (GOTHI), Cairo, Egypt
Angham Mohamed Abd Elmonem Department of Hepatology, Gastroenterology and Infectious Diseases, Shebin El-Kom Teaching Hospital, Shebin El-Kom, Menoufia, Egypt
Hoda Mohamed Rabie Gabal Department of Hepatology, Gastroenterology and Infectious Diseases, Faculty of Medicine, Benha University, Benha, Qalyubiyah, Egypt https://orcid.org/0000-0002-0108-1741

DOI:

https://doi.org/10.3855/jidc.17525

Keywords:

Helicobacter pylori, diagnosis, stool antigen, immunochromatography

Abstract

Introduction: Helicobacter pylori (H. pylori) is one of the most prevalent infections, which can cause chronic gastritis, peptic ulcers and even gastric cancer. Prompt diagnosis and subsequent eradication are essential. Many commercially available H. pylori stool antigen diagnostic kits are used. However, the diagnostic performance of these tests has not yet been evaluated. This study aimed to evaluate two commercial rapid H. pylori Stool Antigen-Lateral Flow Immunochromatography Assay kits (HpSA-LFIA).

Methodology: A total of 88 adult patients with dyspeptic symptoms were included in the study. Full case history was obtained, and fresh stool samples were tested for HpSA by two different kits: RightSign® (BiotesT, Hangzhou, China) and OnSite® (CTK biotech, Poway, USA) and HpSA-enzyme-linked immunosorbent assay (ELISA) as a reference standard.

Results: Of the 88 patients, H. pylori infection was positive in 32 (36.4%), negative in 53 (60.2%), and indeterminate in 3 (3.4%) by ELISA. The sensitivity, specificity, positive predictive value, and negative predictive value were as follows: 96.6%, 66.1%, 62%, and 97.4%, respectively for RightSign® test and 96.9%, 50%, 52.5%, and 96.6%, respectively for OnSite® test.

Conclusions: HpSA-LFIA, RightSign® and OnSite®, are good negative tests, however they cannot be used as a sole test for diagnosis and needs other confirmatory tests in case of positive results.

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Published

2023-05-31

How to Cite

Metwally MAE, Alfeky HM, Alegaily HS, Abbas AH, El Shahat ESA, Abd Elmonem AM, Gabal HMR (2023) Evaluation of two commercially available rapid stool antigen tests for the diagnosis of Helicobacter pylori infection. J Infect Dev Ctries 17:631–634. doi: 10.3855/jidc.17525

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Issue

Vol. 17 No. 05: May 2023

Section

Original Articles

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