Simplified 13C-urea breath test for the diagnosis of Helicobacter pylori infection--the availability of without fasting and without test meal.

The conventional 13C-urea breath test (13C-UBT) for detecting Helicobacter pylori infection was performed during fasting state and with a test meal to delay gastric emptying during the test. For the convenience of propagating this test, we assessed the availability of non-fast and without test meal in 13C-UBT for the diagnosis of H. pylori infection. One hundred and five consecutive patients who received endoscopic examination were studied. All of them received endoscopic biopsy for urease test, culture and histopathology to determine whether there was a presence of H. pylori infection. Each patient received four separate 13C-UBT under the following four testing conditions. Test I) fasting state with test meal (100 ml fresh milk), Test II) non-fast (taking usual food) but with test meal, Test III) fasting state without test meal, and Test IV) non-fast and without test meal. The excess delta 13CO2 values were calculated via the breathed samples that were collected at 15 minutes after ingestion of 13C-urea. There were 61 H. pylori positive and 44 negative patients in this study, with an excess delta 13CO2 values 3.0, 4.0, 3.5 and 4.0 as a cut-off value in the four tests respectively, according to the ROC curve. The results of test I, a conventional procedure, had a good correlation with the gold standard. The sensitivity and specificity were 100% and 95% respectively. The alternative procedures in other tests also have high sensitivity and specificity at 15-minute detecting time. The sensitivity of the tests II, III and IV at 15-minute detecting times were 98%, 98% and 100%, and the specificities of those were 95%, 98% and 95% respectively. We therefore suggest that fasting and test meal possibly be omitted when the cut-off value is 4.0 per mil in the simplified 13C-UBT (non-fast and without test meal, and detection at 15 minutes after ingestion of 13C-urea) which is a simple and available procedure for clinical diagnosis of H. pylori infection.