The Efficacy of 38 mg Low Dose Capsule-Based 13C-urea Breath Test for the Diagnosis of Helicobacter pylori Infection / 대한소화기내시경학회지

ABSTRACT

BACKGROUND/AIMS: Urea breath test (UBT), the noninvasive test for diagnosing Helicobacter pylori infection, was developed in 1987 and had advanced in accuracy and convenience by improvement of analytic device, 13C or 14C urea regimen, expiration sampling protocol and test meal. However, conventional UBT using 75 mg or 100 mg of 13C-urea is expensive and time consuming. The objective of this study was to evaluate the diagnostic performance of UBT using capsulated 38 mg low dose 13C-urea (HeliFinder(R)) developed by Medichems Co., Ltd. METHODS: A total of one hundred forty seven volunteers were enrolled and examined at Catholic University, Korea University, and Soon Chun Hyang University hospital. UBT was performed using 38 mg 13C urea capsule and compared with the gold standard methods (rapid urease test and histology). Baseline and 20 min breath samples were collected. We used delta13C 2.0permile as the cut-off value suggested by the manufacturer. RESULTS: Of the 147 subjects, 142 cases were available for analysis. The sensitivity and specificity of UBT using the 38 mg 13C urea capsule at 20 min were 98.7% and 100% respectively. CONCLUSIONS: A 20 min, 38 mg capsule based 13C urea breath test protocol is more efficient, cost effective, and convenient than conventional protocol.