13C Urea Breath Test forHelicobacter pylori: Evaluation of 10-minute Breath Collection
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AIM: To determine whether a shortened13C urea breath test (13C UBT) (breath collection time of 10 min) is as reliable as the standard assay (30 min).METHODS: Two hundred ninety-seven patients (mean ± SD: 53±16 years, 57% female) completed a13C UBT. Breath samples were obtained at baseline and at 5 min intervals up to 30 min. Sixty-seven patients also underwent endoscopic biopsy. Cluster analysis was performed on the13C UBT data to determine the optimal cut-off point at each time interval. Sensitivity and specificity of the13C UBT at all intervals compared with histology and culture and against the standard 30 min interval were determined.RESULTS: The calculated optimal cut-off points for each time interval (T), expressed as delta over baseline (δ‰), were 3.29 δ‰ at T5, 3.15 δ‰ at T10, 3.42 δ‰ at T15, 3.17 δ‰ at T20, 2.99 δ‰ at T25and 2.82 δ ‰ at T30. Except at T5, the risk of false-positive and false-negative test results at each time interval was lower than 2.3% using these cut-off points. When replacing the cut-off points with 3.0 δ‰, the risk of error was still lower than 2.3%. The test at T10showed 98.6% sensitivity and 98.6% specificity compared with T30. T10and T30showed 100% sensitivity and 96% specificity compared with histology and culture.CONCLUSIONS: The13C UBT is an accurate, noninvasive test, even when the breath sample interval is reduced to 10 min. The present study confirms the validity of a cut-off point of 3.0 δ‰ for the 10 min and 30 min13C UBT.
