Comparison of Sensitivity and Specificity of Helicobacter pylori Detection Kit with Urease Enzyme Using Nucleic Acid Isothermal Amplification assay; Prospective and Observational study

We studied whether the point mutations in domain V of 23S rRNA can affect the eradication failure of H. pylori in prospective, open-label, and observation study. Among enrolled 755 patients, CLO test was positive in 299 patients (39.6%). DNA sequencing analysis of H. pylori 23S rRNA conducted in 295 patients revealed that 2143G point mutation was most frequently found in 24.7% of patients, followed by 2182T mutation in 11.5%. The overall eradication failure rate was 20.9% (42/201) in clarithromycin-based triple-therapy. The patients with 2143G allele had about 60% of eradication failure rate, suggesting a high risk allele of eradication failure. Patients with 2182C without 2143G had 8.7 % of failure rate and without both 2143G and 2182C had only 4.3% of failure rate. The presence of 2143G that was associated with previous eradication history and female sex was independent risk factor for eradication failure. In conclusion, the 2143G point mutation in 23S rRNA of H. pylori was independent risk factor for eradication failure in clarithromycin-based triple-therapy. Personalized tailored therapy based on genotypes of 23S rRNA can increase an eradication success rate in H. pylori infection.