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AIM: To validate an optimized 13C-urea breath test (13C-UBT) protocol for the diagnosis of H pylori infection that is cost-efficient and maintains excellent diagnostic accuracy. METHODS: 70 healthy volunteers were tested with two simplified 13C-UBT protocols,with test meal (Protocol 2) and without test meal (Protocol 1). Breath samples were collected at 10,20 and 30 min after ingestion of 50 mg 13C-urea dissolved in 10 mL of water,taken as a single swallow,followed by 200 mL of water (pH 6.0) and a circular motion around the waistline to homogenize the urea solution. Performance of both protocols was analyzed at various cut-off values. Results were validated against the European protocol. RESULTS: According to the reference protocol,65.7% individuals were positive for H pylori infection and 34.3% were negative. There were no significant differences in the ability of both protocols to correctly identify positive and negative H pylori individuals. However,only Protocol 1 with no test meal achieved accuracy,sensitivity,specificity,positive and negative predictive values of 100%. The highest values achieved by Protocol 2 were 98.57%,97.83%,100%,100% and 100%,respectively. CONCLUSION: A 10 min,50 mg 13C-UBT with no test meal using a cut-off value of 2-2.5 is a highly accurate test for the diagnosis of H pylori infection at a reduced cost.
AIM: To validate an optimized 13C-urea breath test (13C-UBT) protocol for the diagnosis of H pylori infection that is cost-efficient and maintains excellent diagnostic accuracy. METHODS: 70 healthy volunteers were tested with two simplified 13 C- UBT protocols, with test meal (Protocol 2) and without test meal (Protocol 1). Breath samples were collected at 10, 20 and 30 min after ingestion of 50 mg 13C-urea dissolved in 10 mL of water, taken as a single swallow, followed by 200 mL of water (pH 6.0) and a circular motion around the waistline to homogenize the urea solution. Performance of both protocols were analyzed at various cut-off values. Results were validated against the European protocol. RESULTS: According to the reference protocol, 65.7% individuals were positive for H pylori infection and 34.3% were negative. There were no significant differences in the ability of both protocols to correctly identify positive and negative H pylori individuals. However, only Protocol 1 with no test mea The highest values achieved by Protocol 2 were 98.57%, 97.83%, 100%, 100% and 100%, respectively. CONCLUSION: A 10 min, 50 mg 13C-UBT with no test meal using a cut-off value of 2-2.5 is a highly accurate test for the diagnosis of H pylori infection at a reduced cost.