Exosome‐Based Detection of Helicobacter pylori Infection and Clarithromycin Resistance in Children

BACKGROUND: The prevalence of Helicobacter pylori (H. pylori) infection in children is high. Current diagnostic methods, particularly invasive techniques like gastroscopy, pose challenges for pediatric populations, highlighting the need for reliable non-invasive alternatives. AIMS: This study aimed to evaluate the diagnostic value of salivary and urinary exosomes for detecting H. pylori infection and clarithromycin resistance in children. METHODS: Saliva and urine samples were collected from children prior to elective gastroscopy. Exosomal DNA was extracted and subjected to qPCR for the detection of H. pylori DNA and clarithromycin resistance. The sensitivity and specificity of the salivary and urinary exosome tests were calculated against the reference standard, and their performance in detecting resistance was compared with tissue-based results. RESULTS: Among 500 enrolled children, the H. pylori infection rate was 31.6%. Analysis of 500 salivary and 80 urine samples showed that salivary exosomes detected H. pylori with a sensitivity of 93.67% and specificity of 80.11%. Urinary exosomes offered higher specificity (90.56%) but lower sensitivity (62.96%). In the subset of 113 infected children tested for resistance, salivary exosome testing identified clarithromycin resistance in 17.70% of cases, showing a 91.15% concordance with gastric tissue testing (15.93%). The agreement between the two methods was substantial. CONCLUSION: Salivary exosome-based detection represents a highly sensitive and well-tolerated non-invasive method for diagnosing H. pylori infection in children. It also demonstrates substantial agreement with invasive methods in identifying clarithromycin resistance, offering a promising tool to guide precise eradication therapy in the pediatric population.