Romyasamit Chonticha, Kaewdech Apichat, Sripongpun Pimsiri, Chamroonkul Naichaya, Samaeng Maseetoh, Wongprot Dechawat, Saengsuwan Phanvasri, Saki Morteza, Sornsenee Phoomjai
Department of Medical Technology, School of Allied Health Sciences, Walailak University, Nakhon Si Thammarat, 80160, Thailand.
Center of Excellence in Innovation of Essential Oil and Bioactive Compounds, Walailak University, Nakhon Si Thammarat, 80160, Thailand.
Eur J Clin Microbiol Infect Dis. 2025 May 14. doi: 10.1007/s10096-025-05153-1.
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.
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).
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).
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.
幽门螺杆菌是导致包括消化性溃疡和胃癌在内的多种胃肠道疾病的重要病原体。快速准确地检测幽门螺杆菌感染对其早期诊断和治疗至关重要。本研究旨在开发并评估一种用于检测组织活检样本中幽门螺杆菌的比色环介导等温扩增（C-LAMP）检测方法的效能。
共收集302份胃活检样本，并将C-LAMP检测方法的性能与包括培养、聚合酶链反应（PCR）和快速尿素酶试验（CLO试验）在内的传统诊断方法进行比较。
C-LAMP检测方法的检测限为1 CFU/mL，在61℃下反应时间快速，仅需15分钟，突出了其快速诊断的效率。与培养法相比，该检测方法的灵敏度为80%，特异性为98%；而与PCR相比，灵敏度为60%，特异性为100%。受试者工作特征（ROC）分析显示，相对于CLO试验（与PCR相比AUC = 0.63；与培养法相比AUC = 0.65）、培养法（与PCR相比AUC = 0.60）和PCR（与培养法相比AUC = 0.78），C-LAMP检测方法具有更高的诊断准确性（以PCR为参照时AUC = 0.80；以培养法为参照时AUC = 0.89）。
这些结果表明，C-LAMP检测方法是一种用于快速检测幽门螺杆菌的高灵敏度、特异性且具有成本效益的工具，与传统诊断方法相比具有显著优势，特别是在资源有限的环境中，并且C-LAMP检测方法是临床和现场环境中早期可靠检测幽门螺杆菌的一种有前景的替代方法。
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