Comparison between a new 13C-urea breath test, using a film-coated tablet, and the conventional 13C-urea breath test for the detection of Helicobacter pylori infection

Abstract

The (13)C-urea tablet-based method proved to be a simple and accurate test for the diagnosis of H. Pylori infection. Mouth rinsing was not required.

Low Dose Capsule Based 13c-Urea Breath Test Compared With the Conventional 13c-Urea Breath Test and Invasive Tests

“…Although the effects of increasing gastric pH by H 2 -receptor antagonists and sodium bicarbonate solution and of density of H. pylori were already explored during 13 C-urea breath test in solution by Graham et al (12) that concluded H 2 -receptor antagonists differ from proton pump inhibitors as high intragastric pH may cause a reduction in urease activity, unrelated to a reduced bacterial load and reversed by citric acid. When capsule based breath test was validated against a gold standard (urease and histology), the sensitivity and the specificity were high and comparable to previous reports with 13 C-urea in capsule presentation that showed sensitivity of 95%-100% and specificity of 92-100% (7,13,25,27,28) . In conclusion, capsule based breath test with 50 mg 13 C-urea at 20 minutes was found suitable for the clinical setting with 100% sensitivity and specificity.…”

“…There is no interference of the oral flora, as the capsule is swallowed and disintegrated directly in the stomach. Capsules prevented the urea to be released before reaching the stomach, requiring a lower dose of 13 C-urea (7,13,25,27) . In this report, we showed that 13 C-urea breath test performed with formulated 50 mg hard gelatin capsule with citric acid and taken with orange juice (pH = 3.0) had almost perfect agreement (Kappa Index measure of agreement = 1; P<0.05) with the conventional 13 C-urea breath test in powder dissolved in orange juice.…”

“…In Brazil, the conventional test with 13 C-urea in powder dissolved in orange juice has been widely performed in children with doses of 50 mg and 75 mg in patients with less than 30 kg and more than 30 kg, respectively (3,15,16,29) , and in adults (30) . However, the conventional test with liquid 13 C-urea in orange juice may suffer the influence of urease-producing oral flora, increasing 13 CO 2 excre-tion in earlier sample collections with false-positive results, also a higher dose is necessary (7,25,27) . Capsule based 13 C-urea breath test has been reported with lower dose than the conventional test with high sensitivity and specificity, avoiding bacterial oral flora interference, and in a shorter time (7,25,27,28) .…”

“…However, the conventional test with liquid 13 C-urea in orange juice may suffer the influence of urease-producing oral flora, increasing 13 CO 2 excre-tion in earlier sample collections with false-positive results, also a higher dose is necessary (7,25,27) . Capsule based 13 C-urea breath test has been reported with lower dose than the conventional test with high sensitivity and specificity, avoiding bacterial oral flora interference, and in a shorter time (7,25,27,28) . One of the limitations for 13 C-urea breath test to be incorporated into daily gastroenterology practice in Brazil is the substrate ( 13 C-urea) acquisition in capsule presentation (6) .…”

Comparison Between a New Low Dose Urea Capsule Test and the Conventional UBiT ® Tablet Test for the Detection of Helicobacter pylori Infection

“…The currently used UBiT method was employed as the reference standard since a growing number of studies with favorable results for this tablet-based 13 C-UBT implementing the NDIRS have been reported [10,11].…”