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Canadian Journal of Gastroenterology
Volume 20 (2006), Issue 12, Pages 770-774
Original Article

13C Urea Breath Test for Helicobacter pylori: Determination of the Optimal Cut-Off Point in a Canadian Community Population

Marina Mauro, Vladimir Radovic, Pengfei Zhou, Melanie Wolfe, Markad Kamath, Premsyl Bercik, Ken Croitoru, and David Armstrong

Division of Gastroenterology, Department of Medicine, McMaster University, Hamilton, Ontario, Canada

Received 22 March 2006; Accepted 5 April 2006

Copyright © 2006 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


AIM: To determine the test characteristics and the optimal cut-off point for the 13C urea breath test (13C UBT) in a Canadian community laboratory setting.

METHODS: Of 2232 patients (mean age ± SD: 51±21 years, 56% female) who completed a 13C UBT, 1209 were tested to evaluate the primary diagnosis of Helicobacter pylori infection and 1023 were tested for confirmation of eradication following treatment. Cluster analysis was performed on the 13C UBT data to determine the optimal cut-off point and the risk of false-positive and false-negative results. Additionally, 176 patients underwent endoscopic biopsy to allow validation of the sensitivity and specificity of the 13C UBT against histology and microbiology using the calculated cut-off point.

RESULTS: The calculated cut-off points were 3.09 δ‰ for the whole study population (n=2232), 3.09 δ‰ for the diagnosis group (n=1209) and 2.88 δ‰ for the post-treatment group (n=1023). When replacing the calculated cut-off points by a practical cut-off point of 3.0 δ‰, the risk of false-positive and false-negative results was lower than 2.3%. The 13C UBT showed 100% sensitivity and 98.5% specificity compared with histology and microbiology (n=176) for the diagnosis of active H pylori infection.

CONCLUSIONS: The 13C UBT is an accurate, noninvasive test for the diagnosis of H pylori infection and for confirmation of cure after eradication therapy. The present study confirms the validity of a cutoff point of 3.0 δ‰ for the 13C UBT when used in a large Canadian community population according to a standard protocol.