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Diagnostic performance of immunohistochemistry and rapid urease test in detecting <i>Helicobacter pylori</i>, emphasizing bacterial localization and mucosal changes: a retrospective cross-sectional study

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Background: Accurate detection of <i>Helicobacter pylori</i> is essential for diagnosing and managing gastritis and related gastrointestinal disorders. This study evaluated the diagnostic performance of the rapid urease test (RUT) and immunohistochemistry (IHC) using four antibodies (BioGenex, MBL, Cell Marque, and Dako), focusing on bacterial localization (surface vs. subepithelial) and associated mucosal changes.Methods: Gastric biopsy specimens from patients undergoing upper endoscopy at Vajira Hospital (June–December 2022) were retrospectively analyzed. Histological evaluations included hematoxylin and eosin staining, RUT, and IHC. Sensitivity of each antibody for detecting <i>H. pylori</i> was compared, emphasizing subepithelial colonization and histopathological patterns.Results: The BioGenex antibody exhibited the highest sensitivity, followed by MBL, Cell Marque, and Dako antibodies. RUT demonstrated the lowest sensitivity, particularly in cases of chronic nonactive gastritis or minimal mucosal changes. BioGenex detected the greatest number of subepithelial <i>H. pylori</i> cases, many of which were missed by the other antibodies and RUT. Subepithelial colonization appeared as dot-like signals indicative of coccoid forms or bacterial remnants. The BioGenex antibody identified all subepithelial cases detected by the TMDU antibody, highlighting the former’s superior sensitivity. Statistical analysis confirmed the significantly higher diagnostic accuracy of the BioGenex antibody across multiple histological subgroups (<i>p</i><0.05).Conclusion: Subepithelial <i>H. pylori</i> colonization is clinically important but often missed by RUT and less sensitive IHC antibodies. The BioGenex antibody showed superior detection of both surface and subepithelial bacteria. Patients suspected of subepithelial infection without surface bacteria should undergo urea breath or stool antigen testing per guidelines.

Abstract

Background: Accurate detection of <i>Helicobacter pylori</i> is essential for diagnosing and managing gastritis and related gastrointestinal disorders. This study evaluated the diagnostic performance of the rapid urease test (RUT) and immunohistochemistry (IHC) using four antibodies (BioGenex, MBL, Cell Marque, and Dako), focusing on bacterial localization (surface vs. subepithelial) and associated mucosal changes.Methods: Gastric biopsy specimens from patients undergoing upper endoscopy at Vajira Hospital (June–December 2022) were retrospectively analyzed. Histological evaluations included hematoxylin and eosin staining, RUT, and IHC. Sensitivity of each antibody for detecting <i>H. pylori</i> was compared, emphasizing subepithelial colonization and histopathological patterns.Results: The BioGenex antibody exhibited the highest sensitivity, followed by MBL, Cell Marque, and Dako antibodies. RUT demonstrated the lowest sensitivity, particularly in cases of chronic nonactive gastritis or minimal mucosal changes. BioGenex detected the greatest number of subepithelial <i>H. pylori</i> cases, many of which were missed by the other antibodies and RUT. Subepithelial colonization appeared as dot-like signals indicative of coccoid forms or bacterial remnants. The BioGenex antibody identified all subepithelial cases detected by the TMDU antibody, highlighting the former’s superior sensitivity. Statistical analysis confirmed the significantly higher diagnostic accuracy of the BioGenex antibody across multiple histological subgroups (<i>p</i><0.05).Conclusion: Subepithelial <i>H. pylori</i> colonization is clinically important but often missed by RUT and less sensitive IHC antibodies. The BioGenex antibody showed superior detection of both surface and subepithelial bacteria. Patients suspected of subepithelial infection without surface bacteria should undergo urea breath or stool antigen testing per guidelines.

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