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

Korean J Gastrointest Endosc > Volume 30(3); 2005 > Article

Korean Journal of Gastrointestinal Endoscopy 2005;30(3): 126-132.

Helicobacter pylori 감염에서 38 mg 저용량 ¹³C-요소캡슐을 이용한 요소호기검사의 유용성

김용식·전훈재·진윤태·김한겸·현진해·정인식*·최명규*·김상우*·이인석*·박경신*·심찬섭^†·조주영^†·이준성^†·정인섭^†·진소영^†

고려대학교 의과대학, *가톨릭대학교 의과대학, ^†순천향대학교 의과대학 내과학교실

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

Yong Sik Kim, M.D., Hoon Jai Chun, M.D., Yoon Tae Jeen, M.D., Han Kyum Kim, M.D., Jin Hai Hyun, M.D., In Sik Chung, M.D.*, Myung Gyu Choi, M.D.*, Sang Woo Kim, M.D.*, In Seok Lee, M.D.*, Gyeong Sin Park, M.D.*, Chan Sup Shim, M.D.^†, Joo Young C

Department of Internal Medicine, Institute of Digestive Disease and Nutrition, Korea University College of Medicine, *Department of Internal Medicine, College of Medicine, The Catholic University of Korea, ^†Department of Internal Medicine, Institute for Digestive Research, Soonchunhyang University College of Medicine, Seoul, Korea

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^Ⱂ) 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 ∆¹³C 2.0‰ 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. (Korean J Gastrointest Endosc 2005;30:126⁣132)

Key Words: Helicobacter pylori, Urea breath test, ¹³C urea, Capsule

주요어: Helicobacter pylori, 요소호기검사, ¹³C-요소캡슐