ARJ C13 Urea Breath Test System

Author(s):  
2019 ◽  
Vol 12 ◽  
pp. 263177451984340 ◽  
Author(s):  
Vered Richter ◽  
Jeff O. Gonzalez ◽  
Sabine Hazan ◽  
Gary Gottlieb ◽  
Keith Friedenberg ◽  
...  

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.


2012 ◽  
Vol 132 (5) ◽  
pp. 601-607 ◽  
Author(s):  
Ryohkan Funakoshi ◽  
Haruko Yokoyama ◽  
Noriko Kawai ◽  
Kenji Kobayashi ◽  
Fumiaki Ueno ◽  
...  

2001 ◽  
Vol 120 (5) ◽  
pp. A653 ◽  
Author(s):  
Olga Hegedus ◽  
Ann-Sofie Rehnberg ◽  
Carina Bengtsson ◽  
Ragnar Befrits ◽  
Marta Granström ◽  
...  

2004 ◽  
Vol 23 (13) ◽  
pp. 2049-2060 ◽  
Author(s):  
Joanna X. Du ◽  
Terry Watkins ◽  
Luis E. Bravo ◽  
Elizabeth T. H. Fontham ◽  
M. Constanza Camargo ◽  
...  

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Doron Boltin ◽  
Zohar Levi ◽  
Tsachi Tsadok Perets ◽  
Hemda Schmilovitz-Weiss ◽  
Rachel Gingold-Belfer ◽  
...  

Background. There are continual efforts to identify factors which influence the success of first-line therapy for Helicobacter pylori (H. pylori) infection. The 13C-urea breath test result (C13-UBT) utilizes H. pylori urease activity and is a highly accurate diagnostic assay. We aimed to determine whether the magnitude of C13-UBT result is related to treatment success. Methods. Adult patients who underwent a first-time 13C-urea breath test between January 2010 and January 2016 were included. In order to isolate a naïve test-and-treat population who were unlikely to have undergone an initial endoscopy-based H. pylori test, we excluded patients > 45 years and those with a previous C13-UBT. Data were extracted from the Clalit Health Services laboratory database. Results. A total of 94,590 subjects (36.1% male, age 28.5 ± 6.0 years) who underwent a first-time C13-UBT during the study period were included. C13-UBT was positive in 48,509 (51.3%) subjects. A confirmatory posttreatment C13-UBT was performed in 18,375 (37.8%), and eradication was successful in 12,018 (65.4%). The mean C13-UBT recording was 20.6 ± 16.2 DOB in subjects with successful eradication and 19.5 ± 13.1 DOB in subjects with treatment failure (OR, 1.01; 95% CI 1.00-1.01, p<0.01). Among patients in the upper quintile of C13-UBT measurement, eradication was achieved in 67.6%, compared to 62.6% in the lower quintile (OR, 1.22; 95% CI 1.11-1.35, p<0.01). Subjects in the top 1 percentile (C13-UBT ≥ 70 DOB) achieved eradication in 75.0%, compared to 65.3% among subjects with C13-UBT < 70 DOB (OR, 1.59; 95% CI 1.05-2.41, p<0.01). Conclusions. The superiority in H. pylori eradication observed in subjects with a higher C13-UBT DOB is small but significant. Further studies should examine the physiological and microbiological basis for this finding.


Sign in / Sign up

Export Citation Format

Share Document