A multicenter prospective study on the diagnostic performance of a new liquid rapid urease test for the diagnosis of Heliobacteri pylori infection.

Dolak, Werner, Bilgilier, Ceren, Stadlmann, Alexander, Leiner, Judith, Püspök, Andreas, Plieschnegger, Wolfgang, Siebert, Franz, Wewalka, Friedrich, Schöfl, Rainer, Huber-Schönauer, Ursula, Datz, Christian, Biowski-Frotz, Susanne, Högenauer, Christoph, Schrutka-Kölbl, Christiane, Makristathis, Athanasios, Schöniger-Hekele, Maximilian and Steininger, Christoph (2017) A multicenter prospective study on the diagnostic performance of a new liquid rapid urease test for the diagnosis of Heliobacteri pylori infection. Gut pathogens, 9. p. 78. ISSN 1757-4749

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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. Methods: The 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. Results: From 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). Conclusions: This 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:, Date of registration: 24.09.2014, Date of enrolment of the first participant to the trial: 15.01.2015.
Item Type: Article
Divisions: Ordensklinikum Linz Elisabethinen > Interne 4 - Gastroenterologie & Hepatologie, Stoffwechsel & Ernährungsmedizin, Endokrinologie
Depositing User: Prof. Dr. Rainer Schöfl
Date Deposited: 29 Oct 2019 12:32
Last Modified: 29 Oct 2019 12:32

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