Dataset Information

Modified Helicobacter test using a new test meal and a ¹³C-urea breath test in Helicobacter pylori positive and negative dyspepsia patients on proton pump inhibitors.

ABSTRACT:

Aim

To determine the sensitivity and specificity of the ¹³C-urea breath test (UBT) in patients taking proton pump inhibitors (PPIs), using a new test meal Refex.

Methods

One hundred and fourteen consecutive patients with dyspepsia, 53 Helicobacter pylori (H. pylori) positive, 49 H. pylori negative, were included in the study. The patients were then given esomeprazole 40 mg for 29 consecutive days, and the ¹³C-UBT with the new test meal was performed the next morning.

Results

The sensitivity of the ¹³C-UBT with a cut off 2.5‰ was 92.45% (95%CI: 81.79%-97.91%) by per-protocol (PP) analysis and 78.13% (95%CI: 66.03%-87.49%) by intention-to-treat (ITT) analysis. The specificity of the ¹³C-UBT test was 96.00% in the ITT population (95%CI: 86.29%-99.51%) and 97.96% in the PP population (95%CI: 89.15%-99.95%).

Conclusion

The new test meal based ¹³C-UBT is highly accurate in patients on PPIs and can be used in those unable to stop their PPI treatment.

SUBMITTER: Tepes B

PROVIDER: S-EPMC5583580 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Modified <i>Helicobacter</i> test using a new test meal and a <sup>13</sup>C-urea breath test in <i>Helicobacter pylori</i> positive and negative dyspepsia patients on proton pump inhibitors.

Tepeš Bojan B Malfertheiner Peter P Labenz Joachim J Aygen Sitke S

World journal of gastroenterology 20170801 32

<h4>Aim</h4>To determine the sensitivity and specificity of the <sup>13</sup>C-urea breath test (UBT) in patients taking proton pump inhibitors (PPIs), using a new test meal Refex.<h4>Methods</h4>One hundred and fourteen consecutive patients with dyspepsia, 53 <i>Helicobacter pylori</i> (<i>H. pylori</i>) positive, 49 <i>H. pylori</i> negative, were included in the study. The patients were then given esomeprazole 40 mg for 29 consecutive days, and the <sup>13</sup>C-UBT with the new test meal wa ...[more]

PMID: 28932087

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Project description:The objective of the study was to ascertain an optimal Helicobacter pylori diagnostic strategy using population-level laboratory data comparing the performance of serology against urea breath test (UBT). H. pylori diagnostic test results for serology and UBT from two laboratories over a 12-year period (2006-20017) were extracted, linked, and analyzed. A subset of this population underwent both methods of testing within days of each other, enabling a direct comparison of the two methods. The average prevalence of H. pylori positivity was 21.3% by serology and 17.5% by UBT. There were 2,612 individuals who had serology performed first, followed by UBT within 14 days. For this subset, the sensitivity of serology compared with UBT was 96.5% with a specificity of 79.2%. The negative predictive value for serology was 98.4%. Contrary to various recent clinical guidelines, the data show that serology still has utility as a sensitive enough test to be used as an initial H. pylori screening test in a lower prevalence population. Negative serology can be used with confidence to rule out active infection, whereas a positive serology could be followed up with a UBT or a similar performing test such as stool antigen to differentiate active from past infection. For population-based diagnostic recommendations, such a strategy may be ideal since serology generally costs less than UBT and may be combined with a blood draw being done for other diagnostic tests. Continuing to offer serology increases options for patients and may provide economic benefits for single-payer health care systems or health maintenance organizations.ImportanceThis study compares the performance of serology with urea breath test in the diagnosis of Helicobacter pylori in a population-level data set and mimics a head-to-head direct comparison as the study population had both tests performed within 2 weeks of each other. This provides new information supporting the use of serology in a diagnostic algorithm. There are several instances where serology could be preferable to patients to rule out disease, despite some guidelines suggesting serology should not be used.

Project description:Helicobacter pylori (H. pylori) can cause gastritis, peptic ulcer diseases and gastric carcinoma. Endoscopy as the gold standard method of diagnosis is an invasive procedure that might not be suitable in all scenarios. Therefore, this first study in Jordan aimed to assess the non-invasive 13C urea breath test (UBT) and stool antigen test for diagnosis of H. pylori infection and the successfulness of eradication therapy as alternatives for endoscopy. Hence, a total of 30 patients attending the endoscopy units at Alkarak teaching hospital were asked to complete a questionnaire with demographic and clinical data. They were then tested for H. pylori using 13C UBT and H. pylori stool antigen before having endoscopy. Another 30 patients who were positive for H. pylori by endoscopy were tested using both tests 6 weeks post eradication therapy. Results showed that the rate of H. pylori detection using endoscopy was 56.7% (17/30). Heartburns (82.3%, p value = 0.019), epigastric pain (88.2%, p value = 0.007) and vomiting (70.5%, p value = 0.02) were the most significant symptoms. Family history of peptic ulcer diseases was significantly associated with an increased risk for having a H. pylori positive result (p value = 0.02). Compared to endoscopy, the sensitivity of 13C UBT for the diagnosis of H. pylori was 94.1% (16/17), while it was 76.5% (13/17) for the stool antigen test. The specificity of both tests was equal (76.9%). However, the positive predictive and negative predictive values (84.2% and 90.9%) for 13C UBT were higher than those (81.3% and 71.4%) for the stool antigen test. The accuracy of 13C UBT was 86.7% compared to 76.7% for the stool antigen test. There was an 87% agreement (20 patients out of 23) between both tests when used to assess success of the eradication therapy. In conclusion, the 13C UBT was found to be more sensitive and accurate than the stool antigen test when used for diagnosis; furthermore, it has a comparable outcome to the stool antigen test in assessing the successfulness of the eradication treatment.

Dataset Information

Modified Helicobacter test using a new test meal and a ¹³C-urea breath test in Helicobacter pylori positive and negative dyspepsia patients on proton pump inhibitors.

Aim

Methods

Results

Conclusion

Publications

Modified <i>Helicobacter</i> test using a new test meal and a <sup>13</sup>C-urea breath test in <i>Helicobacter pylori</i> positive and negative dyspepsia patients on proton pump inhibitors.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Modified Helicobacter test using a new test meal and a 13C-urea breath test in Helicobacter pylori positive and negative dyspepsia patients on proton pump inhibitors.

Aim

Methods

Results

Conclusion

Publications

Modified <i>Helicobacter</i> test using a new test meal and a <sup>13</sup>C-urea breath test in <i>Helicobacter pylori</i> positive and negative dyspepsia patients on proton pump inhibitors.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Modified Helicobacter test using a new test meal and a ¹³C-urea breath test in Helicobacter pylori positive and negative dyspepsia patients on proton pump inhibitors.