Comparison Between a New Low Dose Urea Capsule Test and the Conventional UBiT ® Tablet Test for the Detection of Helicobacter pylori Infection

BACKGROUND: The urea breath test (UBT) is regarded as a highly reliable, noninvasive tool for diagnosing Helicobacter pylori infection. We compared a recently developed low-dose 38 mg (13)C-urea capsule, which is able to eliminate oral urease effects and does not require positional changes during the test, with the conventionally used 100 mg (13)C-urea tablet method. METHODS: Thirty-nine volunteers were tested under informed consent with both (13)C-UBT methods, Helifinder(R) and UBiT-IR300(R), with a minimum 2-week washout period. The pre-ingestion and 20-minute post-ingestion breath samples were analyzed with an isotope ratio mass spectrometer for Helifinder, and a nondispersive isotope-selective infrared spectrophotometer for UBiT samples. RESULTS: Helifinder method showed excellent agreement with UBiT among 19 positive and 20 negative cases (weighted kappa value, 1.0). Helifinder results (y) showed good agreement but with a proportional bias compared to UBiT results (x) by Passing and Bablok method (y=0.551x-0.255, r=0.74, P<0.0001). CONCLUSIONS: Since the low-dose 38 mg (13)C-urea capsule (Helifinder) test, which is more convenient and economic, showed comparable results with the conventional UBiT method, it can be used as an alternative for the diagnosis of H. pylori infection.