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

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; Austrian Helicobacter Pylori Study Group

doi:10.1186/s13099-017-0226-5

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

Gut Pathog. 2017 Dec 22:9:78. doi: 10.1186/s13099-017-0226-5. eCollection 2017.

Authors

Werner Dolak¹, Ceren Bilgilier², Alexander Stadlmann², Judith Leiner³, Andreas Püspök⁴, Wolfgang Plieschnegger⁵, Franz Siebert⁵, Friedrich Wewalka⁶, Rainer Schöfl⁶, Ursula Huber-Schönauer⁷, Christian Datz⁷, Susanne Biowski-Frotz⁸, Christoph Högenauer⁹, Christiane Schrutka-Kölbl¹⁰, Athanasios Makristathis¹¹, Maximilian Schöniger-Hekele¹, Christoph Steininger²; Austrian Helicobacter Pylori Study Group

Affiliations

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, Währinger Gürtel 18-20, 1090 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.

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.

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: 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.

Keywords: Endoscopy; Helicobacter pylori; Rapid urease test.