Safety and efficacy of the point-of-care BreathID®Hp and BreathID®Hp Lab System 13C-Urea breath test for the detection of H. pylori in children

Abstract

Despite the fact that urea breath test (UBT) for the diagnosis of Helicobacter pylori (H. pylori) has high sensitivity and specificity, the accuracy of UBT in pediatrics is less than that of adults. The aim of the current study was to prospectively determine the safety and the diagnostic accuracy of the 13C-UBT for the detection of H. pylori using the point-of-care continuous BreathID®Hp and the breath sampling bag test, BreathID®Hp Lab System, in a pediatric population. Fifty-three children performed the 13C-UBT via both the BreathID®Hp and the BreathID® Hp Lab System and were asked to provide a stool sample for conventional H. pylori antigen testing. BreathID®Hp sensitivity was 93.3% [95% CI (68.05%; 99.83%)] and specificity was 100% [95% CI (86.77%; 100.00%)] compared to stool antigen. The overall agreement in detection of H. pylori using the BreathID®Hp breath test versus the stool antigen test was 97.56% [95% CI (87.14%; 99.94%)]. BreathID®Hp Lab System sensitivity was 93.3% [95% CI (68.05%; 99.83%)] and specificity was 100% [95% CI (87.23%; 100.00%)] compared to stool antigen. The overall agreement in detection of H. pylori using the BreathID®Hp Lab System breath test versus the stool antigen test was 97.62% [95% CI (87.43%; 99.94%)]. One minor possibly related adverse event was recorded. Conclusions: Both the BreathID®Hp and the BreathID®Hp Lab System breath sample collection devices were safe and accurate in diagnosis of H. pylori infection in children. *Correspondence to: Sunny Z Hussain, Willis-Knighton Pediatric GI Specialist/ Willis-Knighton Health System, Shreveport, LA, USA, Tel: 318-212-5858; Fax 318212-5877; E-mail: Shussain@wkhs.com Tzippora Shalem, The Kamila Gonczarowski Institute of Gastroenterology, Shamir (Assaf Harofeh) Medical Center and the Sackler School of Medicine, Tel Aviv University, Israel, E-mail: tzippi.shalem@gmail.com