Development of a colorimetric loop-mediated isothermal amplification assay for Helicobacter pylori detection.

[PURPOSE] Helicobacter pylori is an important pathogen responsible for various gastrointestinal disorders, including peptic ulcers and gastric cancer. Rapid and accurate detection of H. pylori infection is crucial for its early diagnosis and treatment. This study aimed to develop and evaluate the efficacy of a colorimetric loop-mediated isothermal amplification (C-LAMP) assay for the detection of H. pylori in tissue biopsy samples.

[METHODS] In total, 302 gastric biopsy samples were collected, and the performance of the C-LAMP assay was compared with that of conventional diagnostic methods, including culture, PCR, and rapid urease test (CLO test).

[RESULTS] The detection limit of the C-LAMP assay was 1 CFU/mL with a rapid reaction time of 15 min at 61 °C, highlighting its efficiency for rapid diagnosis. Compared to culture, the assay demonstrated a sensitivity of 80% and specificity of 98%, whereas compared to PCR, sensitivity was 60% and specificity was 100%. ROC analysis revealed superior diagnostic accuracy of the C-LAMP assay (AUC = 0.80 using PCR as reference; AUC = 0.89 using culture as reference) relative to the CLO test (AUC = 0.63 vs. PCR; AUC = 0.65 vs. culture), culture (AUC = 0.60 vs. PCR), and PCR (AUC = 0.78 vs. culture).

[CONCLUSION] These results suggest that the C-LAMP assay is a highly sensitive, specific, and cost-effective tool for rapid detection of H. pylori, offering significant advantages over conventional diagnostic methods, particularly in resource-limited settings, and the C-LAMP assay is a promising alternative for early and reliable H. pylori detection in both clinical and field settings.