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

Gut Pathogens

卷:9

for the Austrian Helicobacter Pylori Study Group¹  Athanasios Makristathis²  Ceren Bilgilier³  Alexander Stadlmann³  Christoph Steininger³  Christiane Schrutka-Kölbl⁴  Werner Dolak⁵  Maximilian Schöniger-Hekele⁵  Christoph Högenauer⁶  Friedrich Wewalka⁷  Rainer Schöfl⁷  Andreas Püspök⁸  Ursula Huber-Schönauer⁹  Christian Datz⁹  Franz Siebert¹⁰  Wolfgang Plieschnegger¹⁰  Judith Leiner¹¹  Susanne Biowski-Frotz¹² 

[1] ;

[2] Clinical Microbiology, Medical University of Vienna;

[3] Department of Medicine I, Infectious Diseases, Internal Medicine I, Medical University of Vienna;

[4] Endoskopie Schrutka;

[5] Gastroenterology and Hepatology, Internal Medicine III., Medical University of Vienna;

[6] Gastroenterology and Hepatology, Internal Medicine, Medical University of Graz;

[7] Internal Medicine 4, Elisabethinen Hospital Linz;

[8] Internal Medicine II, Hospital of the Brothers of Saint John of God Eisenstadt;

[9] Internal Medicine, Hospital Oberndorf;

[10] Internal Medicine, Hospital of the Brothers of Saint John of God St Veit/Glan;

[11] Internal Medicine, Ladislaus Batthyány-Strattmann Hospital Kittsee;

[12] Ordination Dr. Susanne Biowski-Frotz;

关键词: Helicobacter pylori;    Rapid urease test;    Endoscopy;   

DOI  :  10.1186/s13099-017-0226-5

来源: DOAJ

【 摘 要 】

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

【 授权许可】

Unknown