Academic Journal
Double-site rapid urease test versus histopathology for the diagnosis of Helicobacter pylori among patients with dyspepsia on proton pump inhibitors-A diagnostic accuracy study.
| Title: | Double-site rapid urease test versus histopathology for the diagnosis of Helicobacter pylori among patients with dyspepsia on proton pump inhibitors-A diagnostic accuracy study. |
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| Authors: | Yadav AI; Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160 012, India., Jearth V; Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160 012, India. vaneet.jearth@gmail.com., Sharma AK; Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160 012, India., Singh AK; Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160 012, India., Chauhan P; Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160 012, India., Patial P; Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160 012, India., Sekar A; Department of Pathology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160 012, India., Shah J; Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160 012, India., Mandavdhare H; Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160 012, India., Rana SS; Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160 012, India., Dutta U; Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160 012, India. |
| Source: | Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology [Indian J Gastroenterol] 2026 Aug; Vol. 45 (4), pp. 706-714. Date of Electronic Publication: 2025 Jun 12. |
| Publication Type: | Journal Article; Comparative Study |
| Language: | English |
| Journal Info: | Publisher: Springer India Country of Publication: India NLM ID: 8409436 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 0975-0711 (Electronic) Linking ISSN: 02548860 NLM ISO Abbreviation: Indian J Gastroenterol Subsets: MEDLINE |
| Imprint Name(s): | Publication: India : Springer India Original Publication: Bombay : Indian Society of Gastroenterology |
| MeSH Terms: | Helicobacter Infections*/diagnosis , Helicobacter Infections*/pathology , Helicobacter Infections*/complications , Helicobacter pylori*/isolation & purification , Helicobacter pylori*/genetics , Proton Pump Inhibitors*/adverse effects , Proton Pump Inhibitors*/administration & dosage , Dyspepsia*/etiology , Dyspepsia*/microbiology , Dyspepsia*/drug therapy , Urease*/analysis, Humans ; Prospective Studies ; Female ; Biopsy ; Sensitivity and Specificity ; Polymerase Chain Reaction ; Male ; Predictive Value of Tests ; Middle Aged ; Rapid Diagnostic Tests ; Adult |
| Abstract: | Background and Aims: In real-world settings, many patients cannot or do not stop proton pump inhibitors (PPIs) due to symptoms, but guidelines do not address H. pylori testing in PPI users. We compared the rapid urease test (RUT) and histopathology (HPE) when H. pylori testing and endoscopy are indicated for patients with a recent history of PPI use. Methods: A prospective study of 164 patients who used PPIs within two weeks of endoscopy was conducted. Gastric antrum and body biopsies were used for double-site RUT and polymerase chain reaction (PCR) analyses. The updated Sydney protocol was followed for HPE. Patients with at least two out of three positive tests were considered infected with H. pylori. Fifty patients, who underwent only PCR for H. pylori diagnosis after stopping PPIs for two weeks, were enrolled as controls to assess the effect on detection rates. Additionally, an analysis utilizing PCR as the gold standard was conducted. Results: In patients on PPIs, there was no significant difference in detection rates (positivity rate) between HPE and RUT (31.7% vs. 27.4%, p = 0.3771 [McNemar]). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and diagnostic accuracy of double-site RUT were 89.13%, 96.61%, 91.11%, 95.80% and 94.51%, respectively, whereas HPE was 82.61%, 88.14%, 73.08%, 92.86% and 86.59%. PCR had a much greater detection rate and there was no significant difference in detection rate by the PCR method in patients on and off PPI for at least two weeks prior to testing for H. pylori (48% vs. 44%, p = 0.58). The sensitivity of double-site RUT and HPE was still comparable, albeit low, when only PCR was considered the gold standard (43.75% vs. 40%, respectively). Atrophic gastritis and intestinal metaplasia are found in approximately 9% and 5% of gastric body biopsies and 9% and 2.5% of gastric antrum biopsies, respectively. Conclusion: PPI use does not affect PCR-based testing for H. pylori. If PCR-based testing is unavailable, double-site RUT offers a cost-effective alternative for H. pylori testing in PPI users at the point of care, particularly in resource-limited settings, in comparison to HPE. The choice between biopsy using validated protocols or double RUT is also contingent upon the underlying risk factors for gastric cancer. (© 2025. Indian Society of Gastroenterology.) |
| Competing Interests: | Declarations. Conflict of interest: AIY, VJ, AKS, AnKS, PC, PP, AS, JS, HM, SSR and UD declare no competing interests. Ethics statement: The study was performed conforming to the Helsinki Declaration of 1975, as revised in 2000 and 2008 concerning human and animal rights, and the authors followed the policy concerning informed consent as shown on Springer.com. Ethical approval: Study was carried out after approval from Institutional Ethical Committee (IEC-INT/2022/DM- 242). Consent to participate: All patients submitted written informed consent prior to their enrolment in the trial. Disclaimer: The authors are solely responsible for the data and the contents of the paper. In no way, the Honorary Editor-in-Chief, Editorial Board Members, the Indian Society of Gastroenterology or the printer/publishers are responsible for the results/findings and content of this article. |
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| Contributed Indexing: | Keywords: H. pylori; Double-site RUT; HPE; Real-world conditions; Sydney protocol |
| Substance Nomenclature: | 0 (Proton Pump Inhibitors) EC 3.5.1.5 (Urease) |
| Entry Date(s): | Date Created: 20250612 Date Completed: 20260616 Latest Revision: 20260616 |
| Update Code: | 20260616 |
| DOI: | 10.1007/s12664-025-01789-1 |
| PMID: | 40504417 |
| Database: | MEDLINE |
| ISSN: | 0975-0711 |
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| DOI: | 10.1007/s12664-025-01789-1 |