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

Area of Science:

• Gastroenterology
• Oncology
• Infectious Diseases

Background:

• Helicobacter pylori infection is a primary cause of gastric cancer.
• Gastric cancer develops progressively through chronic superficial gastritis, atrophic gastritis, and intestinal metaplasia.
• Accurate H. pylori diagnosis is vital for gastric cancer prevention, but existing methods may be less sensitive in the presence of precursor lesions.

Purpose of the Study:

• To evaluate the diagnostic performance of various H. pylori detection methods across different stages of gastric precursor lesions.
• To identify optimal diagnostic strategies for H. pylori infection in the context of gastric cancer prevention.

Main Methods:

• A multicenter prospective study involving 462 patients undergoing upper endoscopy.
• Patients were tested using rapid urease test (RUT), C14 urea breath test (UBT), biopsy qPCR, stool antigen test (SAT), serology, hematoxylin & Eosin (H&E) staining, and immunohistochemistry (IHC).
• A composite reference standard defined H. pylori infection positivity based on multiple test results or histological detection.

Main Results:

• The diagnostic accuracy of H. pylori tests varied significantly depending on the stage of gastric preneoplastic lesions.
• The urea breath test (UBT) demonstrated low sensitivity.
• Quantitative polymerase chain reaction (qPCR) and stool antigen test (SAT) showed superior overall performance.
• Combining SAT with H&E staining yielded the highest sensitivity (0.848).
• A non-invasive combination of UBT + SAT offered robust sensitivity (0.790).

Conclusions:

• The accuracy of H. pylori diagnostic tests is influenced by the stage of gastric disease.
• Multimodal diagnostic approaches are essential for enhancing H. pylori detection rates.
• Accurate risk stratification for gastric cancer prevention requires improved diagnostic strategies.