Real-time gastric juice analysis with EndoFaster for H. pylori diagnosis: a large, multicentre study

Abstract

Background Helicobacter pylori infection is the main cause of the most frequent gastroduodenal diseases. Because its prevalence is decreasing in developed countries, gastric biopsies are negative in several patients. By measuring ammonium in the gastric juice, EndoFaster allows to exclude H. pylori infection during endoscopy. This study aimed to assess the accuracy of device versions working with either 6 ml or 3 ml of gastric juice. Study design This prospective study involved 12 endoscopic units. During endoscopy, EndoFaster testing was performed and standard five gastric biopsies were taken. The accuracy was calculated by considering histological assessment as the gold standard for H. pylori diagnosis. Results Gastric juice analysis was attempted in 1279 patients, but it failed in 131 (15.5%) and in 10 (2.3%), with the 6 ml and the 3 ml device, respectively (P < 0.001). Overall, EndoFaster detected H. pylori infection with an 86.3% sensitivity, 83.3% specificity, 52.7% positive predictive value, 96.6% negative predictive value and 83.8% accuracy. The performance was not affected either by ongoing proton pump inhibitor therapy or a previous H. pylori eradication. No significant difference in accuracy emerged between the two versions of the device. Conclusion The novel version of the EndoFaster device operating with 3 ml gastric juice may be performed in virtually all patients, and it allows excluding H. pylori infection with a very high accuracy. Gastric biopsies can be avoided in a definite portion of cases without endoscopic lesions or other clinical indications.

Real-time assessment of H. pylori during the endoscopic assessment of individuals with gastric intestinal metaplasia: a possible way to reduce the burden of care

“…In a very recent multicentre study [23] conducted on more than 1000 patients, the real-time assessment of ammonia had an accuracy of 84%, a sensitivity of 86%, a specificity of 83% and an NPV of 97%. These data confirm the results obtained in our study and, in particular, the very high NPV, which could permit to exclude Hp infection in case of negative results at the real-time assessment.…”

Gastric juice analysis in clinical practice: why, how, and when. The experience with EndoFaster

“…By using a > 62 ppm ammonium in gastric juice and 4.5 pH value as threshold, the tool was found to be highly accurate both in diagnosing H. pylori infection and in suspecting diffuse atrophy of gastric mucosa, respectively [25][26][27][28]. Finally, the last version of EndoFaster was further enhanced so that only 3 mL gastric juice are needed for the analysis, with the pH value measured within 15 s, and ammonium concentrations generally in 60 s, and at maximum within 90 s [29]. The device achieved the Health Technology Assessment by the Italian Ministry of Health documenting a positive impact on cost-benefit when it is applied in an endoscopic centre performing ≥2000 upper endoscopies yearly [30].…”

“…By reviewing the available data in the literature, a total of 11 studies were retrieved, including one study that assessed both H. pylori infection and atrophic gastritis, whose quality was quoted as good (N = 4) or fair (N = 7) according to the MINORS scale [31]. In detail, 8 studies with 2071 patients assessed the accuracy of EndoFaster in diagnosing H. pylori infection (Table 1) [24,25,29,[32][33][34][35][36]. Overall, the values of sensitivity, specificity, positive predictive value (PPV), NPV, accuracy, positive likelihood ratio (LR), and negative LR were 90%, 86%, 67%, 96%, 87%, 8.5, and 0.13, respectively.…”

“…Overall, the NPV was >96% in all, but one study. Noteworthy, it was observed that the very high NPV for both H. pylori infection and diffuse gastric atrophy is not significantly affected by ongoing PPI therapy, a condition encountered in more than 40% of patients who undergo upper endoscopy in clinical practice [27,29]. In detail, the NPV for H. pylori infection was found to be 96.6% and 96.9% in patients with and without PPI therapy, respectively, and the overall accuracy was 84% and 85% [26].…”

“…Similarly, the NPV for diffuse atrophy on gastric mucosa was 97% in patients with ongoing PPI and 96% in those without therapy, whilst the accuracy dropped from 90 to 69% [27]. Another relevant finding reported is that the performance of EndoFaster is not reduced by a previous H. pylori eradication therapy [26,29], most likely due to its very high sensitivity in assessing ppm of ammonium in gastric juice, disclosing the presence of even a few bacteria. The ROC curves and nomograms to calculate post-test probability based on different pre-test probabilities for both H. pylori infection and gastric atrophy were provided in Fig.…”