Cargando…
A multicenter prospective study on the diagnostic performance of a new liquid rapid urease test for the diagnosis of Helicobacter pylori infection
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 pros...
Autores principales: | , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5740919/ https://www.ncbi.nlm.nih.gov/pubmed/29299067 http://dx.doi.org/10.1186/s13099-017-0226-5 |
_version_ | 1783288107604377600 |
---|---|
author | 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 Steininger, Christoph |
author_facet | 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 Steininger, Christoph |
author_sort | Dolak, Werner |
collection | PubMed |
description | 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 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13099-017-0226-5) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5740919 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-57409192018-01-03 A multicenter prospective study on the diagnostic performance of a new liquid rapid urease test for the diagnosis of Helicobacter 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 Steininger, Christoph Gut Pathog Research 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 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13099-017-0226-5) contains supplementary material, which is available to authorized users. BioMed Central 2017-12-22 /pmc/articles/PMC5740919/ /pubmed/29299067 http://dx.doi.org/10.1186/s13099-017-0226-5 Text en © The Author(s) 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research 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 Steininger, Christoph A multicenter prospective study on the diagnostic performance of a new liquid rapid urease test for the diagnosis of Helicobacter pylori infection |
title | A multicenter prospective study on the diagnostic performance of a new liquid rapid urease test for the diagnosis of Helicobacter pylori infection |
title_full | A multicenter prospective study on the diagnostic performance of a new liquid rapid urease test for the diagnosis of Helicobacter pylori infection |
title_fullStr | A multicenter prospective study on the diagnostic performance of a new liquid rapid urease test for the diagnosis of Helicobacter pylori infection |
title_full_unstemmed | A multicenter prospective study on the diagnostic performance of a new liquid rapid urease test for the diagnosis of Helicobacter pylori infection |
title_short | A multicenter prospective study on the diagnostic performance of a new liquid rapid urease test for the diagnosis of Helicobacter pylori infection |
title_sort | multicenter prospective study on the diagnostic performance of a new liquid rapid urease test for the diagnosis of helicobacter pylori infection |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5740919/ https://www.ncbi.nlm.nih.gov/pubmed/29299067 http://dx.doi.org/10.1186/s13099-017-0226-5 |
work_keys_str_mv | AT dolakwerner amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT bilgilierceren amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT stadlmannalexander amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT leinerjudith amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT puspokandreas amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT plieschneggerwolfgang amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT siebertfranz amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT wewalkafriedrich amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT schoflrainer amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT huberschonauerursula amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT datzchristian amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT biowskifrotzsusanne amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT hogenauerchristoph amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT schrutkakolblchristiane amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT makristathisathanasios amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT schonigerhekelemaximilian amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT steiningerchristoph amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT amulticenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT dolakwerner multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT bilgilierceren multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT stadlmannalexander multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT leinerjudith multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT puspokandreas multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT plieschneggerwolfgang multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT siebertfranz multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT wewalkafriedrich multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT schoflrainer multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT huberschonauerursula multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT datzchristian multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT biowskifrotzsusanne multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT hogenauerchristoph multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT schrutkakolblchristiane multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT makristathisathanasios multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT schonigerhekelemaximilian multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT steiningerchristoph multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection AT multicenterprospectivestudyonthediagnosticperformanceofanewliquidrapidureasetestforthediagnosisofhelicobacterpyloriinfection |