The validity of breath collection bags method in detecting Helicobacter pylori using the novel BreathID ® Hp Lab System : a multicenter clinical study in 257 subjects.
Background and Aim: The BreathID ® Hp urea breath test provides several advantages over other 13C breath analyzers for the detection of Helicobacter pylori. We evaluated the sensitivity and specificity of a new BreathID ® Hp Lab System (Exalenz Bioscience Ltd, Israel), a 13C-urea breath test system...
| Publicado en: | Therapeutic Advances in Gastrointestinal Endoscopy Vol. 12 |
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| Autores principales: | , , , , , , , , , , , , , , , |
| Formato: | clinical trial pictorial research tables/charts Journal Article |
| Publicado: |
Sage Publications Inc.
5/30/2019
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=138595247&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 138595247 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 26317745 M8AA jtl: Therapeutic Advances in Gastrointestinal Endoscopy issn: 26317745 maglogo: Y pubinfo: dt: 5/30/2019 vid: 12 pid: 344 pub: Sage Publications Inc. place: Thousand Oaks, California artinfo: ui: 138595247 138595247 138595247 10.1177/2631774519843401 138595247 ppct: 1 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: The validity of breath collection bags method in detecting Helicobacter pylori using the novel BreathID ® Hp Lab System : a multicenter clinical study in 257 subjects. aug: au: Richter, Vered Gonzalez, Jeff O. Hazan, Sabine Gottlieb, Gary Friedenberg, Keith Gatof, David Ganeshappa, Ravi Delgado, Jorge-Shmuel Abramowitz, Dov Hardi, Robert Coates, Allan Haq, Mahmudul Mehta, Nilesh Jones, Blake A. Moss, Steven F. Shirin, Haim affil: Institute of Gastroenterology, Liver Diseases and Nutrition, Assaf Harofeh Medical Center, Tel-Aviv University, Zerifin, Israel sug: subj: Sensitivity and Specificity Helicobacter Infections Diagnosis Breath Tests Methods Urea Diagnostic Use Breath Tests Equipment and Supplies Isotopes Diagnostic Use Human Multicenter Studies Histology Urea Metabolism Helicobacter Pylori Metabolism Helicobacter Infections Microbiology Urease Metabolism Pretest-Posttest Design Reproducibility of Results Stability Descriptive Statistics Immunohistochemistry Biopsy Helicobacter Infections Pathology Urease Diagnostic Use Patient Safety United States Israel Male Female Adult Middle Age Aged Endoscopy, Gastrointestinal Confidence Intervals kappa Statistic Comparative Studies Clinical Trials Funding Source Technology, Medical Adult: 19-44 years Middle Aged: 45-64 years Aged: 65+ years Male Female ab: Background and Aim: The BreathID ® Hp urea breath test provides several advantages over other 13C breath analyzers for the detection of Helicobacter pylori. We evaluated the sensitivity and specificity of a new BreathID ® Hp Lab System (Exalenz Bioscience Ltd, Israel), a 13C-urea breath test system using breath sampling bags that facilitates multiple testing in a multicenter international clinical study. Methods: A total of 257 subjects with evaluable results for urea breath test, rapid urease test, and histology were enrolled into two study groups: 189 naïve subjects were included in the pre-therapy group, and 68 subjects comprised the post-eradication therapy group. Analytical studies were conducted to evaluate the stability, reproducibility, and repeatability of the 13C-urea breath test results using a delta over baseline cut-off value of 5. Results: Among the pre-therapy subjects evaluated with the composite results from the rapid urease test and histology/immunohistochemistry, 176 results matched those of the urea breath test, resulting in an overall agreement of 98.3% with a sensitivity of 100% and specificity of 97.9%. In the post-eradication therapy cohort, the overall agreement between the urea breath test and the biopsy diagnosis was 98.5%; the sensitivity of the urea breath test in this cohort was 92.3% and the specificity was 100%. There was uniformly high overall reproducibility (99.48%) of the test results over different batches of breath sample bags, when analyzed on different days and under different storage conditions, showing stability of the breath samples in the breath collection bags Conclusion: The BreathID ® Hp Lab System is a highly accurate and dependable method for the diagnosis of H. pylori infection. pubtype: Academic Journal doctype: clinical trial pictorial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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