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

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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Is the Remarkable Contradiction between Histology and 14C Urea Breath Test in the Detection of Helicobacter pylori due to False-negative Histology or False-positive 14C Urea Breath Test?

Journal of International Medical Research ◽

10.1177/147323000503300604 ◽

2005 ◽

Vol 33 (6) ◽

pp. 632-640 ◽

Cited By ~ 10

Author(s):

AK Gurbuz ◽

AM Ozel ◽

Y Narin ◽

Y Yazgan ◽

H Baloglu ◽

...

Keyword(s):

Helicobacter Pylori ◽

False Positive ◽

Breath Test ◽

False Negative ◽

Urea Breath Test ◽

Predictive Values ◽

Urease Test ◽

H Pylori ◽

Micro Organisms ◽

Positive Results

We assessed the diagnostic value of the 14C urea breath test (UBT) in the detection of Helicobacter pylori compared with histology and the rapid urease test (RUT). The study included 68 patients (22 men and 46 women) with dyspeptic symptoms. H. pylori status was evaluated by 14C UBT, RUT and histology. Sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy were determined for 14C UBT and for RUT. Histology revealed dense yeast-like micro-organisms in the biopsy specimens in all patients with false-positive results by 14C UBT (n = 8), a significantly higher proportion than in patients with negative 14C UBT (five of 31). The low specificity of the H. pylori14C UBT should not be neglected by accepting histology results as false-negative. Gastric mucosal colonization by yeast-like micro-organisms with urease activity can account for the high frequency of false-positive results for 14C UBT.

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

PEDIATRICS ◽

10.1542/peds.90.4.608 ◽

1992 ◽

Vol 90 (4) ◽

pp. 608-611 ◽

Cited By ~ 1

Author(s):

Y. Vandenplas ◽

U. Blecker ◽

T. Devreker ◽

E. Keppens ◽

J. Nijs ◽

...

Keyword(s):

Predictive Value ◽

Gold Standard ◽

Breath Test ◽

False Negative ◽

Urea Breath Test ◽

Negative Results ◽

False Negative Results ◽

13C Urea Breath Test ◽

H Pylori ◽

Noninvasive Tests

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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Serology Is More Sensitive Than Urea Breath Test or Stool Antigen for the Initial Diagnosis of Helicobacter pylori Gastritis When Compared With Histopathology

American Journal of Clinical Pathology ◽

10.1093/ajcp/aqaa043 ◽

2020 ◽

Vol 154 (2) ◽

pp. 255-265

Author(s):

Dustin E Bosch ◽

Niklas Krumm ◽

Mark H Wener ◽

Matthew M Yeh ◽

Camtu D Truong ◽

...

Keyword(s):

Helicobacter Pylori ◽

Access To Care ◽

Breath Test ◽

Diagnostic Error ◽

Urea Breath Test ◽

Positive Serology ◽

Noninvasive Test ◽

Stool Antigen ◽

And Performance ◽

H Pylori

Abstract Objectives To assess the concordance and performance characteristics of Helicobacter pylori laboratory tests compared with histopathology and to propose algorithms for the diagnosis of H pylori that minimize diagnostic error. Methods H pylori diagnostics were reviewed from a 12-year period within a health system (2,560 cases). Analyses were performed to adjust diagnostic performance based on treatment and consensus histopathologic diagnoses among pathologists. Markers of access to care, including test cancellation frequency and turnaround time, were assessed. Costs and performance of candidate noninvasive testing algorithms were modeled as a function of disease prevalence. Results Serum H pylori IgG demonstrated a higher sensitivity (0.94) than urea breath and stool antigen tests (0.64 and 0.61, respectively). Evidence of an advantage in access to care for serology included a lower cancellation rate. Interobserver variability was higher (κ = 0.34) among pathologists for cases with a discordant laboratory test than concordant cases (κ = 0.56). A model testing algorithm utilizing serology for first-time diagnoses minimizes diagnostic error. Conclusions Although H pylori serology has modestly lower specificity than other noninvasive tests, the superior sensitivity and negative predictive value in our population support its use as a noninvasive test to rule out H pylori infection. Reflexive testing with positive serology followed by either stool antigen or urea breath test may optimize diagnostic accuracy in low-prevalence populations.

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Helicobacter pylori: From Infection to Cure

Canadian Journal of Gastroenterology ◽

10.1155/1996/640239 ◽

1996 ◽

Vol 10 (3) ◽

pp. 167-172

Author(s):

ABR Thomson

Keyword(s):

Helicobacter Pylori ◽

False Negative ◽

Eradication Therapy ◽

Erosive Esophagitis ◽

Gastric Body ◽

Negative Results ◽

False Negative Results ◽

Increased Risk ◽

Major Interest ◽

H Pylori

Over 380 abstracts, presentations and posters of recent advances were highlighted at the European and InternationalHelicobacter pylorimeeting held July 7 to 9, 1995 in Edinburgh, Scotland. New advances abound, with major interest focusing on the simple, safe, inexpensive new `gold standard’ forH pylorieradication therapy: a single week of tid omeprazole 20 mg, metronidazole 400 mg and clarithromycin 250 mg, or omeprazole 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg. To avoid false negative results, two biopsies must be taken from the antrum and two from the gastric body at least four weeks after completion of eradication therapy, and ideally should be supplemented with at least one furtherH pyloritest such as a biopsy for urease activity or culture, or a urea breath test. While most patients with a gastric or duodenal ulcer (DU) who do not consume nonsteroidal anti-inflammatory drugs are infected withH pylori, the association is much less apparent in those with a DU who present with an upper gastrointestinal hemorrhage.H pylorieradication for nonulcer dyspepsia is not widely recommended, and the patient with a DU given effectiveH pylorieradication who presents with dyspepsia likely has erosive esophagitis rather than recurrent DU orH pylori. Gastroenterologists are at increased risk ofH pyloriinfection, particularly older gastroenterologists who are very busy endoscopists.

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Noninvasive Diagnostic Tests for Helicobacter Pylori Infection in Children

Canadian Journal of Gastroenterology ◽

10.1155/2005/213608 ◽

2005 ◽

Vol 19 (7) ◽

pp. 433-439 ◽

Cited By ~ 28

Author(s):

Sibylle Koletzko

Keyword(s):

Helicobacter Pylori ◽

Breath Test ◽

Clinical Decision Making ◽

Age Groups ◽

Eradication Therapy ◽

High Sensitivity ◽

Urea Breath Test ◽

Helicobacter Pylori Infection ◽

Noninvasive Test ◽

H Pylori

Noninvasive tests can be used for the initial diagnosis of Helicobacter pylori infection and to monitor the success of eradication therapy. In populations with a low prevalence of H pylori infection (children living in North America and Europe), a high sensitivity is required to make the test valuable for clinical practice. The13C-urea breath test has been validated in children of different age groups in a significant number of infected and noninfected children in several countries and, thus far, is the only noninvasive test that fulfills sensitivity and specificity quality standards. In studies to date, enzyme immunoassays using monoclonal antibodies to detect H pylori antigen in stool provide excellent results, but the number of children tested, particularly post-treatment, is not sufficient to recommend the test. All other noninvasive stool tests or methods based on the detection of specific antibodies in serum, whole blood, urine or saliva have limited accuracy in comparison with the13C-urea breath test. Therefore, these tests cannot be recommended for clinical decision making in pediatric patients.

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M1120 Helicobacter pylori Breath Test in an Open Access System Has a High Rate of Potentially False Negative Results. Negative Result Should Be Considered False Negative Until Proven Otherwise

Gastroenterology ◽

10.1016/s0016-5085(10)61546-6 ◽

2010 ◽

Vol 138 (5) ◽

pp. S-336

Author(s):

Jin Cai ◽

Snorri Olafsson

Keyword(s):

Helicobacter Pylori ◽

Open Access ◽

Breath Test ◽

False Negative ◽

High Rate ◽

Access System ◽

Negative Results ◽

False Negative Results

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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 Testing to Diagnose Helicobacter pylori Infection in Children

Canadian Journal of Gastroenterology ◽

10.1155/1999/328084 ◽

1999 ◽

Vol 13 (7) ◽

pp. 567-570 ◽

Cited By ~ 5

Author(s):

Colette Deslandres

Keyword(s):

Helicobacter Pylori ◽

Breath Test ◽

High Specificity ◽

Epidemiological Studies ◽

Urea Breath Test ◽

Spontaneous Clearance ◽

Noninvasive Test ◽

Specificity And Sensitivity ◽

H Pylori ◽

The Impact

The causal relationship between Helicobacter pylori colonization of the gastric mucosa and gastritis has been proven. Endoscopy and subsequent histological examination of antral biopsies have been regarded as the gold standard for diagnosing H pylori gastritis. The 13C urea breath test is a noninvasive test with a high specificity and sensitivity for H pylori colonization. Increasingly, it is becoming an important tool for use in diagnosing H pylori infection in paediatric populations. This test is particularly well suited for epidemiological studies evaluating reinfection rates, spontaneous clearance of infection and eradication rates after therapy. However, few groups have validated the test in the pediatric age group. The testing protocol has not yet been standardized. Variables include fasting state, dose of urea labelled with 13C, delta cutoff level of 13C carbon dioxide, choice of test meal and timing of collection of expired breath samples. Further studies are urgently needed to evaluate critically the impact of H pylori infection in children. The 13C urea breath test should prove very useful in such prospective studies.

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Prevalence of Helicobacter pylori infection and its Associated Risk Factors among symptomatic Residents of Sulaimani city, Kurdistan region, Iraq, 2020

Kurdistan Journal of Applied Research ◽

10.24017/science.2021.1.1 ◽

2021 ◽

pp. 1-12

Author(s):

Seerwan Hama rashid Ali ◽

Sabiha Sharif Salih ◽

Taib Ahmed Hama Sour ◽

Goran Mohammad Raouf ◽

Araz Latif Rahim

Keyword(s):

Risk Factors ◽

Helicobacter Pylori ◽

Breath Test ◽

Human Life ◽

Urea Breath Test ◽

Giemsa Stain ◽

Helicobacter Pylori Infection ◽

Noninvasive Test ◽

H Pylori ◽

Gastric Sample

Helicobacter pylori (H. pylori) bacteria are a microaerobic Gram negative that colonizes in the gastric and duodenum of human. It can cause prolong infection in the human life if not treated. Many of the studies showed that infection by H. pylori can cause some important gastrointestinal illness, such as peptic ulcer, chronic gastritis, gastric adenocarcinoma and mucosa associated lymphoid tissue lymphoma. Recurrence is generally considered as H. pylori recrudescence infection after one year of eradicated treatment. There are many factors involved in the H pylori reinfection, such as the epidemiology of H. pylori infection, condition of the live, development of economical state, and health conditions. The Objectives of this study were to estimate the incidence and determine the risk factors of infection by H. pylori bacteria in dyspeptic patients in Sulaimani city. And the Aims are to estimate prevalence of the Helicobacter pylori and patients’ characteristics in Sulaimani city. This is a cross-sectional study, using a Urea breath test or stained the gastric sample with Giemsa stain, which is including adult participants aged (12-87) years during the period starting from 1 January until 31 December 2020 on Iraqi male and female patients were visiting –Center for Gastroenterology and Hepatology in Sulaimani, city, Iraq. Three hundred and four patients were included, all of them underwent Urea breath test only but eighty-one of the participants underwent endoscopy and stained the gastric sample with Giemsa stain. Urea breath test for Helicobacter pylori was positive in54.9% which have significant correlation with risk factor findings. Results: the incidence rate of H. pylori infection in our study is 54.9%, and mean age of the study participants was (40.49 ±16.39) one hundred and ninety-one cases 62.8% were female and 113 cases 37.2%were male. Infection by H. pylori bacteria is rife in dyspeptic patients; and is more common in the age group of 31-40 years. One of noninvasive test to diagnosis H. pylori is Urea breath test. In conclusions the rate of helicobacter pylori infection in our study is 54.9% among the symptomatic patients, and the overall incidence of H. pylori UBT and Giemsa stain detection rate were 73.4 and 26.6% respectively.

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