Z Gastroenterol 2016; 54 - P25
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

W Dolak 1, C Biligilier 2, A Stadlmann 3, J Leiner 4, A Püspök 5, W Plieschnegger 6, F Siebert 6, F Wewalka 7, R Schöfl 7, U Huber-Schönauer 8, C Datz 8, S Bioski-Frotz 9, C Högenauer 10, C Schrutka-Kölbl 11, A Makristathis 12, M Schöniger-Hekele 1 C Steininger 3, Austria Helicobacter Pylori Study Group
  • 1Medical University Vienna, Internal Medicine III, Gastroenterology and Hepatology, Vienna, Austria
  • 2Medical University Vienna, Internal Medicine I, Infectious Diseases, Vienna, Austria
  • 3Medical University Vienna, Internal Medicine I, Infectious diseases, Vienna, Austria
  • 4Ladislaus Batthyány-Strattmann Hospital Kittsee, Internal Medicine, Kittsee, Austria
  • 5Hospital of the Brothers of Saint John of God Eisenstadt, Internal Medicine, Eisenstadt, Austria
  • 6Hospital of the Brothers of Saint John of God St. Veit/Glan, Internal Medicine, St. Veit/Glan, Austria
  • 7Elisabethinen Hospital Linz, Internal Medicine IV, Linz, Austria
  • 8Hospital Oberndorf, Internal Medicine, Oberndorf, Austria
  • 9Ordination Dr. Susanne Bioski-Frotz, Vienna, Austria
  • 10Medical University Graz, Internal Medicine, Gastroenterology and Hepatology, Graz, Austria
  • 11Endoskopie Schrutka, Vienna, Austria
  • 12Medical University Vienna, Clinical Microbiology, Vienna, Austria

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.