Diagnostic performance of the rapid urease test versus histopathology for diagnosing Helicobacter pylori: A prospective study in Saudi Arabia

Background: Helicobacter pylori (H. pylori) can be quickly identified using a rapid urease test (RUT)/campylobacter-like organism (CLO) test, although its accuracy is often not comparable to histopathology. Therefore, this study aimed to examine the utility of the CLO test in routine endoscopy procedures. Methods: This prospective study enrolled 100 patients undergoing upper gastrointestinal endoscopy. Gastric biopsies were used for CLO and histopathological examination of tissue. The CLO test’s sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated, with histopathology as the reference standard. Results: The CLO test demonstrated a sensitivity of 32.5%, a specificity of 70.0%, a PPV of 81.25%, and an NPV of 20.59%. The overall accuracy was 40%. In patients with recent proton pump inhibitor or antibiotic use, the sensitivity and specificity of the CLO test were 85.71% and 100%, respectively. Conclusion: The CLO test’s moderate capability in diagnosing H. pylori was observed, primarily due to its high PPV; however, its sensitivity is limited. When the CLO test result is negative, it may not detect all infections. Therefore, histopathology or additional tests should be considered. Further research is needed to understand the impact of medication use on test accuracy.