Abstract
BackgroundThe 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.MethodsWe 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.ResultsIn 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.ConclusionsThe 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
Highlights
Helicobacter pylori infection is common in China, with an overall estimated prevalence of 55.8% [1]
We compared the discordance of H. pylori infection status as determined by each urea breath test (UBT) assay to histopathology in three different age groups (Table 2)
In patients aged above 50 years, the discordance was significantly greater in the 14C-UBT group than those who were tested by the 13C-UBT
Summary
Helicobacter pylori infection is common in China, with an overall estimated prevalence of 55.8% [1]. Helicobacter pylori is able to convert urea into carbon dioxide and ammonia via its urease enzyme, where the ammonia is used to neutralize the acid for its survival in the stomach [4]. Based on this feature of H. pylori, the urea breath test (UBT), a non-invasive H. pylori infection diagnostic method was developed. This requires a patient to swallow a capsule containing a dose of urea labeled with carbon-13 (13C) or carbon-14 (14C) isotope. In the Shenzhen Kuichong People’s Hospital, some UBT findings were contradictory to the histology outcomes, this study aimed to assess and compare the diagnostic performance of both 13C- and 14C-UBT assays
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