Mt 21-42: Development and Validation of an Automatic Device Proposed for the Endoscopic Diagnosis of Helicobacter pylori Infection and Atrophic Gastritis

Background: Gastric juice may give important clinico-pathological information, but measurements in this medium are difficult. In this study we present and validate an innovative device (Mt 21-42) performing gastric juice analyses during endoscopy and proposed for the endoscopic diagnosis of Helicobacter pylori infection and hypo/achlorhydria. Methods: Analyses on both aqueous solutions (80 pH buffer + 120 ammonium chloride samples) and human gastric juice were carried out to assess the measuring performance of Mt 21-42 on the ideal and real matrix, respectively. Matrix spike and manipulation tests were also performed to investigate the matrix effect of gastric juice and to evaluate the consequences of its manipulation on the measurements. Furthermore, preliminary clinical tests were performed to evaluate the clinical potentiality of the device. Results:Mt 21-42 showed a good measuring performance on ideal matrix (coefficient variation: pH = 1.3%, ammonium = 2.1%) and real matrix (coefficient variation: pH = 1.2%, ammonium = 1.9%). Analyses on gastric juice excluded a substantial matrix effect (percent recovery =96.5–98.7%) but demonstrated a significant influence of manipulation procedures (p < 0.05). Conclusions: Human gastric juice does not have a substantial matrix effect for pH and ammonium determination, but its manipulation may affect the measurement of these components. Mt 21-42 represents a precise instrument for the measurement of gastric juice and a potential precious tool for the endoscopic detection of H. pylori infection and hypo/achlorhydric conditions.