A Novel Helicobacter pylori Test Based on 16S rRNA Isothermal Amplification Point-of-Care Testing of Throat Swab.

BACKGROUND: Helicobacter pylori (H. pylori) infection is a major risk factor for gastric cancer (GC) and other gastrointestinal diseases. Current non-invasive detection methods for H. pylori, such as 13C-urea breath test (UBT), are constrained by high cost, radiation concerns, prolonged test duration, and susceptibility to false negative results due to medication use. Thus, a rapid, cost-effective, accurate, and medication-resistant detection method for H. pylori infection is urgently needed. MATERIALS AND METHODS: This study developed a novel point-of-care testing for H. pylori infection based on 16S rRNA isothermal amplification, using throat swabs as the detection samples (POCT). To systematically evaluate its diagnostic performance, a multi-center cross-sectional paired diagnostic study was conducted at Shandong Public Health Clinical Center and East Campus of Qilu Hospital, Shandong University from January 2025 to August 2025. This study enrolled a total of 543 participants, all of whom underwent both POCT and UBT simultaneously on the same day. Regarding UBT as the reference gold standard, the diagnosis metrics including accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of POCT for H. pylori detection were analyzed to evaluate its clinical application. RESULTS: The POCT assay exhibited an overall accuracy of 95%, sensitivity of 89%, and specificity of 97%. PPV and NPV were 90% and 96%, respectively. Its high agreement with UBT was confirmed by a Kappa value of 0.860 (p < 0.01). Additionally, the diagnostic performance of POCT also demonstrated high consistency between two centers. CONCLUSIONS: The 16S rRNA isothermal amplification point-of-care testing exhibits excellent diagnostic accuracy for H. pylori infection. It holds the potential to serve as an economic, efficient, and widely applicable alternative to the traditional UBT.