Dataset Information

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.

ABSTRACT: 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.

SUBMITTER: Richter V

PROVIDER: S-EPMC6543788 | biostudies-literature | 2019 Jan-Dec

REPOSITORIES: biostudies-literature

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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.

Richter Vered V Gonzalez Jeff O JO Hazan Sabine S Gottlieb Gary G Friedenberg Keith K Gatof David D Ganeshappa Ravi R Delgado Jorge-Shmuel JS Abramowitz Dov D Hardi Robert R Coates Allan A Haq Mahmudul M Mehta Nilesh N Jones Blake A BA Moss Steven F SF Shirin Haim H

Therapeutic advances in gastrointestinal endoscopy 20190101

<h4>Background and aim</h4>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.<h4>Met ...[more]

PMID: 31192315

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Project description:Virulence of the gastric pathogen Helicobacter pylori (Hp) is directly linked to the pathogen's ability to glycosylate proteins; for example, Hp flagellin proteins are heavily glycosylated with the unusual nine-carbon sugar pseudaminic acid, and this modification is absolutely essential for Hp to synthesize functional flagella and colonize the host's stomach. Although Hp's glycans are linked to pathogenesis, Hp's glycome remains poorly understood; only the two flagellin glycoproteins have been firmly characterized in Hp. Evidence from our laboratory suggests that Hp synthesizes a large number of as-yet unidentified glycoproteins. Here we set out to discover Hp's glycoproteins by coupling glycan metabolic labeling with mass spectrometry analysis. An assessment of the subcellular distribution of azide-labeled proteins by Western blot analysis indicated that glycoproteins are present throughout Hp and may therefore serve diverse functions. To identify these species, Hp's azide-labeled glycoproteins were tagged via Staudinger ligation, enriched by tandem affinity chromatography, and analyzed by multidimensional protein identification technology. Direct comparison of enriched azide-labeled glycoproteins with a mock-enriched control by both SDS-PAGE and mass spectrometry-based analyses confirmed the selective enrichment of azide-labeled glycoproteins. We identified 125 candidate glycoproteins with diverse biological functions, including those linked with pathogenesis. Mass spectrometry analyses of enriched azide-labeled glycoproteins before and after cleavage of O-linked glycans revealed the presence of Staudinger ligation-glycan adducts in samples only after beta-elimination, confirming the synthesis of O-linked glycoproteins in Hp. Finally, the secreted colonization factors urease alpha and urease beta were biochemically validated as glycosylated proteins via Western blot analysis as well as by mass spectrometry analysis of cleaved glycan products. These data set the stage for the development of glycosylation-based therapeutic strategies, such as new vaccines based on natively glycosylated Hp proteins, to eradicate Hp infection. Broadly, this report validates metabolic labeling as an effective and efficient approach for the identification of bacterial glycoproteins.

Project description:IntroductionThe use of activity trackers has increased both among private consumers and in healthcare. It is therefore relevant to consider whether a consumer-graded activity tracker is comparable to or may substitute a research-graded activity tracker, which could further increase the use of activity trackers in healthcare and rehabilitation. Such use will require knowledge of their accuracy as the clinical implications may be significant. Studies have indicated that activity trackers are not sufficiently accurate, especially at lower walking speeds. The present study seeks to inform decision makers and healthcare personnel considering implementing physical activity trackers in clinical practice. This study investigates the criterion validity of the consumer-graded Garmin Vivosmart® HR and the research-graded StepWatch™ 3 compared with manual step count (gold standard) at different walking speeds under controlled conditions.MethodsThirty participants, wearing Garmin Vivosmart® HR at the wrist and StepWatch™ 3 at the ankle, completed six trials on a treadmill at different walking speeds: 1.6 km/h, 2.4 km/h, 3.2 km/h, 4.0 km/h, 4.8 km/h, and 5.6 km/h. The participants were video recorded, and steps were registered by manual step count. Medians and inter-quartile ranges (IQR) were calculated for steps and differences in steps between manually counted steps and the two devices. In order to assess the clinical relevance of the tested devices, the mean absolute percentage error (MAPE) was determined at each speed. A MAPE ≤3% was considered to be clinically irrelevant. Furthermore, differences between manually counted steps and steps recorded by the two devices were presented in Bland-Altman style plots.ResultsThe median of differences in steps between Garmin Vivosmart® HR and manual step count ranged from -49.5 (IQR = 101) at 1.6 km/h to -1 (IQR = 4) at 4.0 km/h. The median of differences in steps between StepWatch™ 3 and manual step count were 4 (IQR = 14) at 1.6 km/h and 0 (IQR = 1) at all other walking speeds. The results of the MAPE showed that differences in steps counted by Garmin Vivosmart® HR were clinically irrelevant at walking speeds 3.2-4.8 km/h (MAPE: 0.61-1.27%) as the values were below 3%. Differences in steps counted by StepWatch™ 3 were clinically irrelevant at walking speeds 2.4-5.6 km/h (MAPE: 0.08-0.35%).ConclusionGarmin Vivosmart® HR tended to undercount steps compared with the manual step count, and StepWatch™ 3 slightly overcounted steps compared with the manual step count. Both the consumer-graded activity tracker (Garmin Vivosmart® HR) and the research-graded (StepWatch™ 3) are valid in detecting steps at selected walking speeds in healthy adults under controlled conditions. However, both activity trackers miscount steps at slow walking speeds, and the consumer graded activity tracker also miscounts steps at fast walking speeds.

Project description:ObjectiveTo introduce a novel technology currently under final development before regulatory approvals for the furtherment of cataract surgery, using the FemtoMatrix® laser system, and to demonstrate its safety and efficacy as compared to standard ultrasound phacoemulsification.MethodsThirty-three patients with bilateral cataracts were operated on with one eye undergoing PhotoEmulsification® treatment on the FemtoMatrix® device and the contralateral eye receiving the control procedure, i.e., standard ultrasound phacoemulsification treatment. The number of "zero-phaco" procedures (denoting that I/A alone was sufficient to aspirate the lens fragments and that no ultrasound energy was needed) was recorded and Effective Phaco Time (EPT) values were compared. The patient follow-up was 3 months.ResultsThirty-three eyes from a population with a mean cataract grade of 2.6 were treated on the FemtoMatrix®, of which 29 were "zero-phaco" (88%). All patients were operated on by a single surgeon who was a relative novice to the technology (63 patients treated prior to this study). Conversely, of the 33 fellow eyes who underwent standard ultrasound phacoemulsification, none were zero-phaco (0%) - all required varying degrees of ultrasound energy to make lens aspiration possible. The mean EPT was significantly lower in the PhotoEmulsification® laser group (0.2 ± 0.8 s) than in the phaco group (1.3 ± 1.2 s) (p < 0.0001). The safety profiles of the two procedures were comparable, with no device-related adverse events noted.ConclusionFemtoMatrix® is a promising femtosecond laser platform that, when compared to phacoemulsification, significantly decreases or eliminates EPT altogether. The system is used to perform PhotoEmulsification®, making zero-phaco cataract procedures feasible including in high-grade cataracts (>3). It enables personalized treatment by automatically measuring and adapting the laser energy required to obtain the most efficient cutting of the crystalline lens. This new technology appears to be safe and effective in cataract surgery.

Dataset Information

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.

Publications

The validity of breath collection bags method in detecting <i>Helicobacter pylori</i> using the novel <i>BreathID</i> <sup>®</sup> <i>Hp Lab System</i>: a multicenter clinical study in 257 subjects.

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