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©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
Intraprocedural gastric juice analysis as compared to rapid urease test for real-time detection of Helicobacter pylori
Riccardo Vasapolli, Florent Ailloud, Sebastian Suerbaum, Jens Neumann, Nadine Koch, Lukas Macke, Jörg Schirra, Julia Mayerle, Peter Malfertheiner, Christian Schulz
Riccardo Vasapolli, Nadine Koch, Lukas Macke, Jörg Schirra, Julia Mayerle, Peter Malfertheiner, Christian Schulz, Medical Department ІІ, University Hospital LMU Munich, Munich 81377, Germany
Riccardo Vasapolli, Sebastian Suerbaum, Lukas Macke, Christian Schulz, Deutsches Zentrum für Infektionsforschung, Partner Site Munich, Munich 81377, Germany
Florent Ailloud, Sebastian Suerbaum, Max von Pettenkofer Institute, Faculty of Medicine, Ludwig-Maximilians University of Munich, Munich 80336, Germany
Florent Ailloud, Sebastian Suerbaum, National Reference Center for Helicobacter pylori, Munich 81377, Germany
Jens Neumann, Institute of Pathology, Faculty of Medicine, Ludwig-Maximilians-University of Munich, Munich 81377, Germany
Author contributions: Vasapolli R, Schulz C, and Malfertheiner P designed the study, interpreted the data and drafted the manuscript; Vasapolli R, Suerbaum S, Schirra J, Mayerle J, Schulz C, and Malfertheiner P obtained funding and supervised the study procedures; Vasapolli R recruited suitable subjects, performed endoscopy, and collected samples; Vasapolli R, Macke L, Ailloud F, and Koch N registered data and performed statistical analyses; Neumann J performed the histological analysis; All authors read and approved the final version of the manuscript.
Supported by the Deutsches Zentrum für Infektionsforschung, Partner Site Munich, Germany, No. TTU 06.715_00; and the Bavarian Ministry of Science and the Arts within the framework of the Bavarian Research Network “New Strategies Against Multi-Resistant Pathogens by Means of Digital Networking – bayresq.net”.
Institutional review board statement: This study was approved by the local ethics committee and government authorities and was conducted in accordance with current Good Clinical Practice guidelines and the Declaration of Helsinki. All recruited subjects provided written informed consent for participation.
Informed consent statement: Written informed consent was obtained from the participants.
Conflict-of-interest statement: The authors have nothing to disclose.
Data sharing statement: Data and analytic methods can be made available to other researchers upon request.
STROBE statement: The authors have read the STROBE statement, and the manuscript was prepared and revised according to the STROBE statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Christian Schulz, MD, Deputy Director, Medical Department ІІ, University Hospital LMU Munich, Marchionini Strasse 15, Munich 81377, Germany.
chr.schulz@med.uni-muenchen.de
Received: November 19, 2022
Peer-review started: November 19, 2022
First decision: December 10, 2022
Revised: January 15, 2023
Accepted: February 22, 2023
Article in press: February 22, 2023
Published online: March 14, 2023
Processing time: 110 Days and 21.4 Hours
ARTICLE HIGHLIGHTS
Research background
Diagnosis of Helicobacter pylori (H. pylori) infection can be rapidly achieved within the framework of gastroscopy by rapid urease test (RUT) or by gastric juice analysis with Endofaster.
Research motivation
The diagnostic performance of the Endofaster has not been compared with that of the RUT, which shares a similar characteristic in terms of providing results in a short-term temporal context through endoscopic examination.
Research objectives
The objective of this prospective study was to validate the diagnostic performance of the Endofaster for H. pylori detection in patients who underwent gastroscopy compared to the diagnostic accuracy of a standard RUT.
Research methods
Patients undergoing routine upper gastrointestinal endoscopy were prospectively recruited. Biopsies were taken to assess gastric histology according to the updated Sydney system and for RUT. Gastric juice sampling and analysis was performed using the Endofaster, and the diagnosis of H. pylori was based on real-time ammonium measurements. Histological detection of H. pylori served as the diagnostic gold standard for comparing Endofaster-based H. pylori diagnosis with RUT-based H. pylori detection.
Research results
Gastric juice analysis with Endofaster could reliably detect H. pylori with an overall sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of 91.5%, 93.0%, 92.6%, 84.3%, and 96.4%, respectively. Gastric juice analysis with Endofaster and RUT were comparable in diagnostic performance and highly concordant in H. pylori detection (κ-value = 0.85).
Research conclusions
Endofaster’s gastric juice analysis is a highly accurate method for the diagnosis of H. pylori infection, comparable to RUT. EGJA-based H. pylori diagnosis has an advantage in terms of on-site immediacy of diagnosis.
Research perspectives
Intraprocedural diagnosis of H. pylori-infection by Endofaster may guide additional sampling for antibiotic susceptibility testing in positive patients or avoid unnecessary biopsies in negative patients.
