The assessment of gastric mucosal integrity is fundamental in the diagnostic pathway of dyspepsia and gastroesophageal reflux disease (GERD), particularly in identifying Helicobacter pylori (HP) infection and atrophic gastritis (AG), both of which have clinical implications for cancer risk stratification and patient management. Histology remains the reference standard for diagnosing HP and AG but requires invasive biopsy sampling, which may be unnecessary in low-risk patients. GastroPanel® is a non-invasive serological test based on four biomarkers that provides information on gastric function, HP status, and the presence of AG, potentially serving as a pre-endoscopic triage tool. Endofaster® is an intra-procedural device that analyzes gastric juice in real time during gastroscopy, measuring pH and detecting HP, with the potential to reduce biopsy use. The aim of this study was to compare the diagnostic agreement of GastroPanel® and Endofaster® with histology for the detection of HP and AG, and to explore their potential complementary roles in the endoscopic workflow.

Thirty consecutive adult patients undergoing upper endoscopy for dyspeptic symptoms or GERD at our institution were prospectively enrolled. Exclusion criteria included prior gastric surgery, food or blood in the stomach. All participants underwent blood sampling for GastroPanel®, real-time gastric juice analysis using Endofaster® during the same endoscopic procedure, and systematic gastric biopsies according to the Sydney protocol. Histology served as the diagnostic gold standard. Diagnostic agreement between each test and histology was quantified using Cohen’s kappa coefficient, interpreted according to established benchmarks. Sensitivity, specificity, and false-negative/false-positive rates were also recorded.

Based on histology, HP infection was detected in 10% (3/30) and AG in 3.3% (1/30) of patients. For HP diagnosis, GastroPanel® showed moderate agreement with histology (κ=0.53), while Endofaster® demonstrated substantial agreement (κ=0.78). For AG detection, agreement was fair for GastroPanel® (κ=0.36) and perfect for Endofaster® (κ=1.00). Although overall agreement was lower for GastroPanel®, it exhibited 100% specificity for both HP and AG, with three false negatives and no false positives. This suggests that a positive GastroPanel® result reliably identifies patients who may benefit from endoscopic evaluation. In contrast, Endofaster® showed 100% sensitivity for both HP and AG, with no false negatives or false positives in this cohort, supporting its potential role in safely omitting gastric biopsies when results are negative. No adverse events related to either test were observed.

This pilot study suggests that GastroPanel® and Endofaster® provide complementary strengths in the diagnostic evaluation of gastric disease. GastroPanel®, through its high specificity, may help identify patients who truly require endoscopic assessment, thereby optimizing referral and resource allocation. Endofaster®, with its high sensitivity and real-time intra-procedural application, may reduce the need for unnecessary biopsies during gastroscopy, streamlining the procedure and minimizing patient burden. Although limited by small sample size and low disease prevalence, these findings support the potential integration of combined non-invasive and real-time diagnostic tools to enhance accuracy and efficiency in the endoscopic pathway. Larger studies are warranted to validate these results and assess cost-effectiveness, workflow impact, and clinical outcomes.