Re-evaluation of Helicobacter pylori diagnostic methods: A multicenter clinical diagnostic accuracy study.

[OBJECTIVES] Helicobacter pylori (H. pylori) infection is the main driver of gastric cancer, with a step-wise progression via chronic superficial gastritis (CSG), atrophic gastritis (CAG), and intestinal metaplasia (IM). While accurate diagnosis of H. pylori infection is central to gastric cancer prevention strategies, current diagnostic methods may vary in sensitivity depending on the presence of gastric precursor lesions.

[METHODS] In this multicenter prospective study, 462 patients undergoing upper endoscopy at three Chinese hospitals were tested using (rapid urease test [RUT], C urea breath test [UBT], biopsy qPCR, stool antigen test [SAT], serology, hematoxilin & Eosin [H&E] staining, and immunohistochemistry [IHC]). A composite reference defined H. pylori infection as positivity in ≥2 of UBT, SAT, or qPCR, or histological detection via H&E/IHC.

[RESULTS] Diagnostic performance of H. pylori tests varied per gastric preneoplastic precursor lesion, with the commonly used UBT showing a low sensitivity. qPCR and SAT demonstrated superior overall performance across all stages. Combining SAT with H&E achieved the highest sensitivity (0.848 [0.765; 0.930]), while UBT + SAT offered a robust non-invasive alternative (sensitivity (0.790 [0.713; 0.866]).

[CONCLUSION] The accuracy of H. pylori tests varies across gastric disease stage. Multimodal diagnostic strategies are needed to improve detection and ensure accurate risk stratification in gastric cancer prevention.