Retrospective Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Feb 16, 2024; 16(2): 64-71
Published online Feb 16, 2024. doi: 10.4253/wjge.v16.i2.64
Retrospective analysis of discordant results between histology and other clinical diagnostic tests on helicobacter pylori infection
Xiaohua Qi, Kevin Kuan, Tony El Jabbour, Yungtai Lo, Qiang Liu, Yanan Fang
Xiaohua Qi, Kevin Kuan, Qiang Liu, Department of Pathology, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY 10467, United States
Tony El Jabbour, Department of Pathology, Albert Einstein College of Medicine/Montefiore Medical Center, New York, NY 10467, United States
Yungtai Lo, Department of Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY 10461, United States
Yanan Fang, Department of Pathology, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY 10467, United States
Co-first authors: Xiaohua Qi and Kevin Kuan.
Author contributions: Qi X and Kuan K contributed equally to this work; Fang Y and Liu Q designed the research study; Qi X and Kuan K performed the data extraction; Kuan K, Qi X, Jabbour T, Liu Y, and Fang Y performed the data analysis and interpretation of the results; Fang Y, Kuan K, and Qi X wrote the manuscript, Lo Y is a Biostatistics professor and performed the statistical analysis; Fang Y, Kuan K and Qi X revised the manuscript; and all authors read and approved the final version.
Institutional review board statement: This study was reviewed and approved by the Albert Einstein College of Medicine Institutional Review Board (IRB No: 2016-6957).
Informed consent statement: This is a retrospective study with a focus on quality assurance (QA). The institutional review board (IRB) granted a waiver of consent.
Conflict-of-interest statement: All the authors declare no conflicts of interest for this article.
Data sharing statement: De-identified dataset available from the corresponding author at Participants gave informed consent for data sharing.
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:
Corresponding author: Yanan Fang, MD, PhD, Associate Professor, Department of Pathology, Montefiore Medical Center/Albert Einstein College of Medicine, 111 East 210th St., Bronx, NY 10467, United States.
Received: November 14, 2023
Peer-review started: November 14, 2023
First decision: December 5, 2023
Revised: December 24, 2024
Accepted: January 11, 2024
Article in press: January 11, 2024
Published online: February 16, 2024

A reliable test is essential for diagnosing Helicobacter pylori (H. pylori) infection, and crucial for managing H. pylori-related diseases. Serving as an excellent method for detecting H. pylori infection, histologic examination is a test that clinicians heavily rely on, especially when complemented with immunohistochemistry (IHC). Additionally, other diagnostic tests for H. pylori, such as the rapid urease test (CLO test) and stool antigen test (SA), are also highly sensitive and specific. Typically, the results of histology and other tests align with each other. However, on rare occasions, discrepancy between histopathology and other H. pylori diagnostic tests occurs.


To investigate the discordance between histology and other H. pylori tests, the underlying causes, and the impact on clinical management.


Pathology reports of gastric biopsies were retrieved spanning August 2013 and July 2018. Reports were included in the study only if there were other H. pylori tests within seven days of the biopsy. These additional tests include CLO test, SA, and H. pylori culture. Concordance between histopathology and other tests was determined based on the consistency of results. In instances where histology results were negative while other tests were positive, the slides were retrieved for re-assessment, and the clinical chart was reviewed.


Of 1396 pathology reports were identified, each accompanied by one additional H. pylori test. The concordance rates in detecting H. pylori infection between biopsy and other tests did not exhibit significant differences based on the number of biopsy fragments. 117 discrepant cases were identified. Only 20 cases (9 with CLO test and 11 with SA) had negative biopsy but positive results in other tests. Four cases initially stained with Warthin-Starry turned out to be positive for H. pylori with subsequent IHC staining. Among the remaining 16 true discrepant cases, 10 patients were on proton pump inhibitors before the biopsy and/or other tests. Most patients underwent treatment, except for two who were untreated, and two patients who were lost to follow-up.


There are rare discrepant cases with negative biopsy but positive in SA or CLO test. Various factors may contribute to this inconsistency. Most patients in such cases had undergone treatment.

Keywords: Helicobacter pylori, Discordance, Gastric biopsy, Histology, Rapid urease test, Stool antigen test, Helicobacter pylori culture

Core Tip: The concordance between histopathology and rapid urease test (CLO test) or stool antigen test (SA) for detecting Helicobacter pylori (H. pylori) detection is excellent. The agreement between histology and H. pylori culture is good. Concordance between histopathology and other tests shows no significant differences based on the number of biopsy fragments. Occasionally, there are rare cases where histology is negative for H. pylori, while the CLO test or SA is positive. The causes of such discrepancies may be multifactorial, necessitating a separate analysis for each case with clinical correlation. Most of these cases were subsequently treated for H. pylori infection.