Use of the EndoFaster® device may reduce the need for gastric biopsies in the detection of Helicobacter pylori (H pylori) infection, according to a study in Digestive and Liver Disease.
This prospective, multicenter study tested whether EndoFaster® (NISO Biomed) may optimize the need for biopsies regarding the detection of H pylori. The device automatically performs gastric juice analysis during upper endoscopy, allowing real-time H pylori detection, and its accuracy was computed with histology of gastric biopsies as a gold standard.
The study enrolled consecutive patients who were referred to undergo diagnostic upper endoscopy. The analysis included 525 patients (mean age, 56 [range, 18-89]; 56% female). During the histological assessment, H pylori was detected in 90 patients, for an overall prevalence of 17.1%. Prevalence was 22.3% when only naïve patients were considered. With use of EndoFaster®, 146 (27.8%) patients were positive and 379 (72.2%) were negative.
The overall accuracy of EndoFaster® for diagnosing patients with H pylori was 85%, with a sensitivity of 87%, specificity of 84%, positive predictive value (PPV) of 53%, and negative predictive value (NPV) of 97%. The value of the area under the curve (AUC) of the receiver operating characteristic (ROC) curve was 0.894.
Regarding use of proton pump inhibitors (PPI), 201 (38.3%) patients were actively receiving therapy and 324 (61.7%) discontinued PPI at least 2 weeks prior to the study. The overall accuracy, specificity, and NPV of EndoFaster® did not differ between the groups, and sensitivity and PPV were higher in patients without PPI therapy.
In the group of 259 patients who were completely naïve (neither previous H pylori therapy nor ongoing PPI use; 58 patients positive for H pylori at histology), the overall accuracy of EndoFaster® for H pylori diagnosis was 84%, with a sensitivity of 86%, specificity of 84%, PPV of 54%, and NPV of 97%.
“By using EndoFaster® in our series, biopsy sampling could have been eventually avoided in a total of 279 patients, accounting for a reduction of 42.3%, accepting the risk of only 8 false negative cases,” stated the investigators.
A potential limitation regarding the findings was the need for 6-mL of gastric juice to correctly accomplish the test, an amount that is not always recovered in the stomach, the study authors noted.
Zulloa Z, Germanà B, Galliani E, et al. Optimizing the searching for H. pylori in clinical practice with EndoFaster®. Dig Liver Dis. Published online March 3, 2021. doi: 10.1016/j.dld.2021.02.004