Contribution of the 13C-Urea Breath Test to the Detection of Helicobacter pylori Gastritis in Children

Serology, 13C-urea breath test, histology, Campylobacter-like organism testing, and culture were performed in 95 consecutive children to evaluate the contribution of these tests to the detection of Helicobacter pylori infection. In analyses considering any combination of three positive tests as "gold standard" for diagnosing H pylori infection, 26 children were Helicobacter positive (27%), which is only one patient more than the number of children with only a positive culture. The accuracy of culture was excellent when "any combination of three positive tests" was used as the gold standard (sensitivity 96%, specificity 100%, positive predictive value 100% [false positivity 0%], negative predictive value 99% [false-negative results 1%]). The results of invasive and noninvasive tests were comparable. When culture was considered as "gold standard," the sensitivity of serology and 13C-urea breath test was 96%; the specificity was 96% and 93%, respectively; the positive predictive value was 89% and 83% (false-positive results in 11% and 17%); and the negative predictive value for both was 99% (false-negative results in 1%). It is concluded that culture can be used as gold standard, but that noninvasive tests such as serology and/or 13C-urea breath test can be used to diagnose H pylori infection in children, since each has at least 95% sensitivity and 92% specificity.

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13C Urea Breath Test for Helicobacter pylori: Determination of the Optimal Cut-Off Point in a Canadian Community Population

Canadian Journal of Gastroenterology ◽

10.1155/2006/472837 ◽

2006 ◽

Vol 20 (12) ◽

pp. 770-774 ◽

Cited By ~ 13

Author(s):

Marina Mauro ◽

Vladimir Radovic ◽

Pengfei Zhou ◽

Melanie Wolfe ◽

Markad Kamath ◽

...

Keyword(s):

Helicobacter Pylori ◽

False Positive ◽

Breath Test ◽

False Negative ◽

Urea Breath Test ◽

Noninvasive Test ◽

Negative Results ◽

False Negative Results ◽

Community Population ◽

H Pylori

AIM: To determine the test characteristics and the optimal cut-off point for the 13C urea breath test (13C UBT) in a Canadian community laboratory setting.METHODS: Of 2232 patients (mean age ± SD: 51±21 years, 56% female) who completed a 13C UBT, 1209 were tested to evaluate the primary diagnosis of Helicobacter pylori infection and 1023 were tested for confirmation of eradication following treatment. Cluster analysis was performed on the 13C UBT data to determine the optimal cut-off point and the risk of false-positive and false-negative results. Additionally, 176 patients underwent endoscopic biopsy to allow validation of the sensitivity and specificity of the 13C UBT against histology and microbiology using the calculated cut-off point.RESULTS: The calculated cut-off points were 3.09 δ‰ for the whole study population (n=2232), 3.09 δ‰ for the diagnosis group (n=1209) and 2.88 δ‰ for the post-treatment group (n=1023). When replacing the calculated cut-off points by a practical cut-off point of 3.0 δ‰, the risk of false-positive and false-negative results was lower than 2.3%. The 13C UBT showed 100% sensitivity and 98.5% specificity compared with histology and microbiology (n=176) for the diagnosis of active H pylori infection.CONCLUSIONS: The 13C UBT is an accurate, noninvasive test for the diagnosis of H pylori infection and for confirmation of cure after eradication therapy. The present study confirms the validity of a cutoff point of 3.0 δ‰ for the 13C UBT when used in a large Canadian community population according to a standard protocol.

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Does low dose13C-urea breath test maintain a satisfactory accuracy in diagnosing Helicobacter pylori infection?

Arquivos de Gastroenterologia ◽

10.1590/s0004-28032011000200004 ◽

2011 ◽

Vol 48 (2) ◽

pp. 104-108 ◽

Cited By ~ 6

Author(s):

Luiz Gonzaga Vaz Coelho ◽

Arilto Eleutério da Silva Jr ◽

Maria Clara de Freitas Coelho ◽

Francisco Guilherme Cancela e Penna ◽

Rafael Otto Antunes Ferreira ◽

...

Keyword(s):

Helicobacter Pylori ◽

Diagnostic Accuracy ◽

Predictive Value ◽

Gold Standard ◽

Breath Test ◽

Standard Test ◽

Urea Breath Test ◽

Gold Standard Test ◽

13C Urea Breath Test ◽

H Pylori

CONTEXT: The standard doses of 13C-urea in 13C-urea breath test is 75 mg. OBJECTIVE: To assess the diagnostic accuracy of 13C-urea breath test containing 25 mg of 13C-urea comparing with the standard doses of 75 mg in the diagnosis of Helicobacter pylori infection. METHODS: Two hundred seventy adult patients (96 males, 174 females, median age 41 years) performed the standard 13C-urea breath test (75 mg 13C-urea) and repeated the 13C-urea breath test using only 25 mg of 13C-urea within a 2 week interval. The test was performed using an infrared isotope analyzer. Patients were considered positive if delta over baseline was >4.0‰ at the gold standard test. RESULTS: One hundred sixty-one (59.6%) patients were H. pylori negative and 109 (40.4%) were positive by the gold standard test. Using receiver operating characteristic analysis we established a cut-off value of 3.4% as the best value of 25 mg 13C-urea breath test to discriminate positive and negative patients, considering the H. pylori prevalence (95% CI: 23.9-37.3) at our setting. Therefore, we obtained to 25 mg 13C-urea breath test a diagnostic accuracy of 92.9% (95% CI: 88.1-97.9), sensitivity 83.5% (95% CI: 75.4-89.3), specificity 99.4% (95% CI: 96.6-99.9), positive predictive value 98.3% (95% CI: 92.4-99.4), and negative predictive value 93.0% (95% CI: 88.6-96.1). CONCLUSIONS: Low-dose 13C-urea breath test (25 mg 13C-urea) does not reach accuracy sufficient to be recommended in clinical setting where a 30% prevalence of H. pylori infection is observed. Further studies should be done to determine the diagnostic accuracy of low doses of 13C-urea in the urea breath test.

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PROSPECTIVE STUDY FOR VALIDATION OF A SINGLE PROTOCOL FOR THE 13C-UREA BREATH TEST USING TWO DIFFERENT DEVICES IN THE DIAGNOSIS OF H. PYLORI INFECTION

Arquivos de Gastroenterologia ◽

10.1590/s0004-2803.201900000-38 ◽

2019 ◽

Vol 56 (2) ◽

pp. 197-201 ◽

Cited By ~ 1

Author(s):

Luiz Gonzaga Vaz COELHO ◽

Osmar Reni TRINDADE ◽

Laiane Alves LEÃO ◽

Henrique Gomes RIBEIRO ◽

Izabella Silva FREITAS ◽

...

Keyword(s):

Gold Standard ◽

Breath Test ◽

Kappa Coefficient ◽

Urea Breath Test ◽

Wilcoxon Test ◽

Breath Sample ◽

Prospective Comparison ◽

Before And After ◽

13C Urea Breath Test ◽

H Pylori

ABSTRACT BACKGROUND: 13C-urea breath test (UBT) is the gold-standard, noninvasive method for H. pylori diagnosis. However, there is no uniform standardization of the test. This situation can be unpractical for laboratories running with two or more devices. OBJECTIVE: To perform a prospective comparison validation study of UBT employing one validated protocol for two different devices: BreathID Hp Lab System® (Exalenz Bioscience Ltd, Israel), here called device A and IRIS-Doc2® (Wagner Analysen-Technik, Germany, now Mayoly Spindler Group, France), here called device B, in the diagnosis of H. pylori infection. METHODS: A total of 518 consecutive patients (365 females, 153 males, mean age 53 years) referred for UBT were included. All patients received device A protocol as follow: after at least one hour fasting, patients filled two bags prior to the test, then ingested an aqueous solution containing 75 mg of 13C-urea with a 4.0 g citric acid powder and filled another two bags 15 min after ingesting the test solution. One pair of breath sample bags (before and after ingestion) was analyzed by the two different devices. A delta over baseline (DOB) ≥5‰ indicated H. pylori infection. Statistics: Wilcoxon test, kappa coefficient with 95% CI, Wilson’s method. RESULTS: Considering the device A protocol as the gold standard, its comparison with device B showed a sensitivity of 99.3% (95% CI: 96.3-99.9) and a specificity of 98.9% (95% CI: 97.3-99.6). Kappa coefficient was 0.976 (95% IC: 0.956-0.997). CONCLUSION: Correlation between the two devices was excellent and supports a uniform standardization of UBT.

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Effect of omeprazole, rabeprazole, and rebamipide on the accuracy of urea breath test in patients with Helicobacter pylori infection

Asian Biomedicine ◽

10.2478/abm-2010-0042 ◽

2010 ◽

Vol 4 (2) ◽

pp. 337-342

Author(s):

Duangporn Thong-Ngam ◽

Maneerat Chayanupatkul ◽

Thirada Thongbai

Keyword(s):

Proton Pump Inhibitors ◽

Proton Pump ◽

Breath Test ◽

False Negative ◽

False Negative Rate ◽

Urea Breath Test ◽

Once Daily ◽

Negative Results ◽

Negative Rate ◽

H Pylori

Abstract Background: The urea breath test (UBT) has been widely used for H. pylori eradication after treatment. The breath test could be adversely affected by various factors including proton pump inhibitors (PPIs) that are also used in the therapy for H. pylori infection. Objective: Determine the effect of omeprazole, rabeprazole and the mucoprotective agent rebamipide, on the UBT. Methods: Fifty-six patients with dyspepsia and positive for H. pylori by rapid urease test were enrolled. They were classified into three groups: Group 1 (n=25) received omeprazole 20 mg once daily, group 2 (n=13) received rabeprazole 20 mg once daily, and group 3 (n=18) received rebamipide 100 mg three times a day. All patients received a 14-day course of their medications. UBT was performed on day 0 as a baseline and on day 14 in all patients. In patient with negative results of UBT on day 14, the UBT was performed in consecutive week until the test became positive. Results: Fifty-six patients (20 men and 36 women) participated in the study. Their mean age was 46.77±14.3 years. False negative rate after 14-day treatment in omeprazole, rabeprazole and rebamipide group were 20.0%, 30.8%, and 0% respectively. There was a significant difference between 13C level in patients with negative and positive UBT results (2.7±0.7 vs.22.9±3.7/mL, p=0.025). The reversal of false negative to true positive tests occurred within two weeks after discontinuation of omeprazole and rabeprazole. Conclusion: Proton pump inhibitors had an effect on the accuracy of H. pylori detection using UBT. Rabeprazole revealed a higher false negative rate in the UBT than omeprazole. The mucoprotective drug, rebamipide, did not influence negative results in the UBT.

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13C-urea breath test for H. pylori detection in children: determination of the cutoff value by graphic method, independent of gold standard comparison

Gastroenterology ◽

10.1016/s0016-5085(03)80883-1 ◽

2003 ◽

Vol 124 (4) ◽

pp. A177 ◽

Cited By ~ 1

Author(s):

Luiz G.V. Coelho ◽

Zildete Rocha ◽

Lucas C. Boechat ◽

Rodrigo O.A. Aguiar ◽

Ana L.A. Aragao ◽

...

Keyword(s):

Gold Standard ◽

Breath Test ◽

Urea Breath Test ◽

Graphic Method ◽

Cutoff Value ◽

13C Urea Breath Test ◽

H Pylori

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A modified 14C-urea breath test eliminates false negative results in patients taking a proton pump inhibitor (PPI).

Gastroenterology ◽

10.1016/s0016-5085(00)84139-6 ◽

2000 ◽

Vol 118 (4) ◽

pp. A504

Author(s):

Krishna Chathadi ◽

Uma Murthy ◽

Jarrod Montague ◽

Mimi Jones ◽

William D. Chey

Keyword(s):

Proton Pump Inhibitor ◽

Proton Pump ◽

Breath Test ◽

False Negative ◽

Urea Breath Test ◽

Negative Results ◽

False Negative Results

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Superiority of MALDI-TOF Mass Spectrometry over Real-Time PCR for SARS-CoV-2 RNA Detection

Viruses ◽

10.3390/v13050730 ◽

2021 ◽

Vol 13 (5) ◽

pp. 730

Author(s):

Magda Rybicka ◽

Ewa Miłosz ◽

Krzysztof Piotr Bielawski

Keyword(s):

Mass Spectrometry ◽

Gold Standard ◽

Viral Genome ◽

False Negative ◽

Rt Pcr ◽

Rna Detection ◽

Maldi Tof ◽

Negative Results ◽

False Negative Results ◽

Pcr Test

At present, the RT-PCR test remains the gold standard for early diagnosis of SARS-CoV-2. Nevertheless, there is growing evidence demonstrating that this technique may generate false-negative results. Here, we aimed to compare the new mass spectrometry-based assay MassARRAY® SARS-CoV-2 Panel with the RT-PCR diagnostic test approved for clinical use. The study group consisted of 168 suspected patients with symptoms of a respiratory infection. After simultaneous analysis by RT-PCR and mass spectrometry methods, we obtained discordant results for 17 samples (10.12%). Within fifteen samples officially reported as presumptive positive, 13 were positive according to the MS-based assay. Moreover, four samples reported by the officially approved RT-PCR as negative were positive in at least one MS assay. We have successfully demonstrated superior sensitivity of the MS-based assay in SARS-CoV-2 detection, showing that MALDI-TOF MS seems to be ideal for the detection as well as discrimination of mutations within the viral genome.

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Evaluation of the Carba NP Test for Rapid Detection of Carbapenemase-Producing Enterobacteriaceae and Pseudomonas aeruginosa

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.00878-13 ◽

2013 ◽

Vol 57 (9) ◽

pp. 4578-4580 ◽

Cited By ~ 147

Author(s):

Nathalie Tijet ◽

David Boyd ◽

Samir N. Patel ◽

Michael R. Mulvey ◽

Roberto G. Melano

Keyword(s):

Pseudomonas Aeruginosa ◽

Positive Predictive Value ◽

Negative Predictive Value ◽

Predictive Value ◽

Rapid Detection ◽

False Negative ◽

Bacterial Extract ◽

Content Type ◽

Negative Results ◽

False Negative Results

ABSTRACTThe Carba NP test was evaluated against a panel of 244 carbapenemase- and non-carbapenemase-producingEnterobacteriaceaeandPseudomonas aeruginosaisolates. We confirmed the 100% specificity and positive predictive value of the test, but the sensitivity and negative predictive value were 72.5% and 69.2%, respectively, and increased to 80% and 77.3%, respectively, using a more concentrated bacterial extract. False-negative results were associated with mucoid strains or linked to enzymes with low carbapenemase activity, particularly OXA-48-like, which has emerged globally in enterobacteria.

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Correlation between Quantitative 13C-Urea Breath Test and Helicobacter pylori Treatment Success in a Population-Based Cohort

Gastroenterology Research and Practice ◽

10.1155/2018/5439539 ◽

2018 ◽

Vol 2018 ◽

pp. 1-6 ◽

Cited By ~ 2

Author(s):

Doron Boltin ◽

Zohar Levi ◽

Tsachi Tsadok Perets ◽

Hemda Schmilovitz-Weiss ◽

Rachel Gingold-Belfer ◽

...

Keyword(s):

Helicobacter Pylori ◽

Breath Test ◽

Treatment Success ◽

Population Based ◽

Urea Breath Test ◽

First Line Therapy ◽

13C Urea Breath Test ◽

Helicobacter Pylori Treatment ◽

H Pylori ◽

First Time

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.

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