Validation of 13C-urea breathtest for the diagnosis of Helicobacter pylori infection in the Singapore population

Abstract

Introduction: Several tests are available for determining the presence of Helicobacter pylori (H. pylori) infection. These may be invasive or non-invasive. The carbon urea breath test (C-UBT) is generally considered to be a simple, non-invasive and accurate test for the detection of H. pylori infection both before and after treatment. Commercially available 13C-UBT kits are generally validated in their country of manufacture and the stated accuracy of their tests may not be applicable to our local population.

Aim: The aim of our study was to determine the accuracy of a commercial 13C-urea breath test kit, Hp-Plus (Utandningstester i Sverige AB, Sweden), in the Singapore population.

Patients and methods: One hundred patients for oesophago-gastro-duodenoscopy (OGD) were recruited into this prospective study. Gastric biopsies were obtained for the biopsy urease test and histological examination. Blood samples were obtained for H. pylori serology. Breath samples were then obtained at baseline and after consumption of 100 mg of labelled 13C-urea. The presence of H. pylori infection was defined by a positive result on any two of the three tests (biopsy urease test, histology, serology) performed for the detection of H. pylori. Using this "gold standard", the sensitivity, specificity, and positive and negative predictive values of the 13C-UBT were calculated.

Results: In the Singapore population, the 13C-UBT (Hp plus) has a sensitivity and specificity of 94.2% and 100% respectively for the detection of H. pylori infection. The positive predictive value and negative predictive value of the 13C-UBT is 100% and 88.6% respectively.

Conclusion: The 13C-UBT is a simple, safe, and accurate non-invasive test for the detection of H. pylori infection, making it a valuable tool in local clinical practice.