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DOI: 10.1055/s-0036-1584003
A multicenter prospective study on the diagnostic performance of a liquid rapid urease test for the diagnosis of Helicobacter pylori infection
Background: Helicobacter pylori (H. pylori) causes a diversity of gastric diseases including gastritis, MALT lymphoma, and gastric adenocarcinoma. Rapid urease tests (RUT) are well established for the point-of-care, invasive diagnosis of H. pylori infection. The study aimed to evaluate the diagnostic performance of a liquid RUT, the preOx-HUT, within a prospective cohort of treatment-naïve patients.
Patients/Methods: The multicenter prospective clinical trial was conducted at nine Austrian centers for gastrointestinal endoscopy. Patients referred for a diagnostic upper gastrointestinal endoscopy were screened to undergo gastric biopsy sampling for routine histological evaluation, and in parallel, the preOx-HUT. Histological evaluation served as reference standard to evaluate the diagnostic performance of the preOx-HUT.
Results: From January 2015 to January 2016, a total of 183 consecutive patients (54 males and 129 females, median age 50 years) were included in this study. Indications for gastroscopy were mostly upper abdominal pain (38%) and reflux symptoms (25%), followed by cancer screening (15%) and dysphagia (5%). Endoscopy revealed pathological findings in 149/183 cases (81%), which were mostly gastritis (59%) and gastro-esophageal reflux disease (27%). An ulcer was found in 4%, a tumor in 2% of cases. H. pylori infection was detected by histology in 41/183 (22%) cases. In relation to histology, the preOx-HUT had a sensitivity of 85%, a specificity of 94%, a positive predictive value of 80% and a negative predictive value of 96%. Concomitant PPI-use (in 28/183 patients, 15%) had no statistically significant effect on the diagnostic accuracy of the preOx-HUT according to logistic regression analysis.
Discussion: This was the first study evaluating the preOx-HUT in a prospective, multicenter clinical setting. Thereby, a high diagnostic accuracy was found for the point-of-care, invasive diagnosis of H. pylori infection. Hence, this test may be a valuable diagnostic adjunct to the clinical presentation of patients with suspected H. pylori infection.