Real-time diagnosis of H. pylori infection during endoscopy: Accuracy of an innovative tool (EndoFaster).

ABSTRACT

BACKGROUND: EndoFaster is novel device able to perform real-time ammonium measurement in gastric juice allowing H. pylori diagnosis during endoscopy. This large study aimed to validate the accuracy of EndoFaster for real-time H. pylori detection. METHODS: Consecutive patients who underwent upper endoscopy in two centres were prospectively enrolled. During endoscopy, 4 ml of gastric juice were aspirated to perform automatic analysis by EndoFaster within 90 seconds, and H. pylori was considered present (>62 ppm/ml) or absent (≤62 ppm/ml). Accuracy was measured by using histology as gold standard, and (13)C-urea breath test (UBT) in discordant cases. Accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) were calculated. RESULTS: Overall, 189 patients were enrolled, but in seven (3.4%) the aspirated gastric juice amount was insufficient to perform the test. The accuracy, sensitivity, specificity, PPV, and NPV were 87.4%, 90.3%, 85.5%, 80.2%, 93.1%, respectively, and 92.6%, 97.1%, 89.7%, 85.9%, 98.0%, respectively, when H. pylori status was reclassified according to the UBT result in discordant cases. CONCLUSIONS: This study found a high accuracy/feasibility of EndoFaster for real-time H. pylori diagnosis. Use of EndoFaster may allow selecting those patients in whom routine gastric biopsies could be avoided.