A multicenter prospective study on the diagnostic performance of a new liquid rapid urease test for the diagnosis of <Emphasis Type="Italic">Helicobacter pylori</Emphasis> infection |
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| Authors: | Werner Dolak Ceren Bilgilier Alexander Stadlmann Judith Leiner Andreas Püspök Wolfgang Plieschnegger Franz Siebert Friedrich Wewalka Rainer Schöfl Ursula Huber-Schönauer Christian Datz Susanne Biowski-Frotz Christoph Högenauer Christiane Schrutka-Kölbl Athanasios Makristathis Maximilian Schöniger-Hekele Christoph Steininger for the Austrian Helicobacter Pylori Study Group |
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| Affiliation: | 1.Gastroenterology and Hepatology, Internal Medicine III.,Medical University of Vienna,Vienna,Austria;2.Department of Medicine I, Infectious Diseases, Internal Medicine I,Medical University of Vienna,Vienna,Austria;3.Internal Medicine,Ladislaus Batthyány-Strattmann Hospital Kittsee,Kittsee,Austria;4.Internal Medicine II,Hospital of the Brothers of Saint John of God Eisenstadt,Eisenstadt,Austria;5.Internal Medicine,Hospital of the Brothers of Saint John of God St Veit/Glan,St Veit,Austria;6.Internal Medicine 4,Elisabethinen Hospital Linz,Linz,Austria;7.Internal Medicine,Hospital Oberndorf,Oberndorf,Austria;8.Ordination Dr. Susanne Biowski-Frotz,Vienna,Austria;9.Gastroenterology and Hepatology, Internal Medicine,Medical University of Graz,Graz,Austria;10.Endoskopie Schrutka,Vienna,Austria;11.Clinical Microbiology,Medical University of Vienna,Vienna,Austria |
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| Abstract: | Background Helicobacter pylori (H. pylori) causes a diversity of gastric diseases. 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 new liquid RUT, the preOx-HUT, within a prospective cohort of treatment-naïve patients.MethodsThe multicenter prospective clinical trial was conducted at nine Austrian centers for gastrointestinal endoscopy. Patients referred for a diagnostic upper gastrointestinal endoscopy underwent gastric biopsy sampling for routine histological evaluation, and in parallel, the preOx-HUT. Histology served as reference standard to evaluate the diagnostic performance of the preOx-HUT.ResultsFrom January 2015 to January 2016, a total of 183 consecutive patients (54 males and 129 females, median age 50 years) were included. Endoscopy revealed pathological findings in 149/183 cases (81%), which were mostly gastritis (59%) and gastro-esophageal reflux disease (27%). 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%. Performance of preOx-HUT was not affected significantly by concomitant PPI-use as present in 15% of cases (P = 0.73).ConclusionsThis was the first study evaluating the preOx-HUT in a prospective, multicenter clinical setting. We found a high diagnostic accuracy for the point-of-care, invasive diagnostic test of H. pylori infection. Hence, this test may be a valuable diagnostic adjunct to the clinical presentation of patients with suspected H. pylori infection. Trial registration number EK 1548/2014, Name of registry: Register der Ethikkommission der Medizinischen Universität Wien, URL of registry: https://ekmeduniwien.at/core/catalog/2012/, Date of registration: 24.09.2014, Date of enrolment of the first participant to the trial: 15.01.2015 |
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