Dataset Information

A re-testing range is recommended for ¹³C- and ¹⁴C-urea breath tests for Helicobacter pylori infection in China.

ABSTRACT:

Background

The urea breath test (UBT) is widely used for diagnosing Helicobacter pylori infection. In the Shenzhen Kuichong People's Hospital, some UBT findings were contradictory to the histology outcomes, therefore this study aimed to assess and compare the diagnostic performance of both ¹³C- and ¹⁴C-UBT assays.

Methods

We recruited 484 H. pylori-treatment naïve patients, among which 217 and 267 were tested by the ¹³C-UBT or ¹⁴C-UBT, respectively. The cutoff value for H. pylori positivity based on manufacturer's instruction was 4% delta over baseline (DOB) for the ¹³C-UBT, and 100 disintegrations per minute (DPM) for the ¹⁴C-UBT. Gastric biopsies of the antrum and corpus were obtained during endoscopy for histopathology.

Results

In patients who were tested using the ¹³C-UBT kit, histopathology was positive in 136 out of 164 UBT-positive patients (82.9% concordance), and negative in 46 out of 53 UBT-negative cases (86.8% concordance). For the ¹⁴C-UBT-tested patients, histopathology was positive for H. pylori in 186 out of 220 UBT-positive patients (84.5% concordance), and negative in 41 out of 47 UBT-negative cases (87.2% concordance). While the ¹³C-UBT and ¹⁴C-UBT each had a high sensitivity level of 95.1% and 96.9%, respectively, their specificity was low, at 62.2% and 54.7%, respectively. By using new optimal cutoff values and including an indeterminate range (3-10.3% DOB for ¹³C-UBT and 87-237 DPM for ¹⁴C-UBT), the specificity values can be improved to 76.7% and 76.9% for the ¹³C- and ¹⁴C-UBT, respectively.

Conclusions

The establishment of an indeterminate range is recommended to allow for repeated testing to confirm H. pylori infection, and thereby avoiding unnecessary antibiotic treatment.

Trial registration

Chinese Clinical Trial Registry, ChiCTR2000041570. Registered 29 December 2020- Retrospectively registered, http://www.chictr.org.cn/edit.aspx?pid=66416&htm=4.

SUBMITTER: Wang X

PROVIDER: S-EPMC8199820 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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

A re-testing range is recommended for ¹³C- and ¹⁴C-urea breath tests for Helicobacter pylori infection in China.

Background

Methods

Results

Conclusions

Trial registration

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OmicsDI is part of the ELIXIR infrastructure

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Dataset Information

A re-testing range is recommended for 13C- and 14C-urea breath tests for Helicobacter pylori infection in China.

Background

Methods

Results

Conclusions

Trial registration

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

A re-testing range is recommended for ¹³C- and ¹⁴C-urea breath tests for Helicobacter pylori infection in China.