Accuracy of breath tests using low doses of 13C-urea to diagnose Helicobacter pylori infection: a randomised controlled trial

Abstract

Background:The 13 C-urea breath test (UBT) for detecting Helicobacter pylori infection is a non-invasive method based on the organism's urease activity. Since its first description, the method has been extensively modified. However, only the dose of 13 C-urea and the measurement equipment are directly related to the cost of the test. Aims: (1) To assess the diagnostic accuracy before eradication therapy of three UBTs using 25, 15, and 10 mg of 13 C-urea, respectively; and (2) to determine diagnostic performance in the post-eradication setting showing the highest values for sensitivity and specificity with the lowest dose of 13 C-urea. Methods: Three hundred consecutive patients were randomised to be tested with one of the three UBTs. All patients underwent upper endoscopy with biopsies. A total of 222 more patients were enrolled to evaluate the second aim. Infected patients were offered treatment and asked to return 4-6 weeks after the end of therapy to perform endoscopic follow up and to carry out 13 C-UBT. Results: In the pretreatment setting, 13 C-UBT 25 mg had a sensitivity of 100% (95% confidence interval (CI) 91.8-100) and a specificity of 100% (95% CI 93.7-100);13 C-UBT 15 mg had a sensitivity of 96.1% (95% CI 86.8-98.9) and a specificity of 100% (95% CI 92.6-100); and 13 C-UBT 10 mg had a sensitivity of 89.1% (95% CI 77-95.3) and a specificity of 100% (95% CI 93.3-100). As the test with the best performance and the lowest dose of 13 C-urea was 13 C-UBT 15 mg, it was evaluated after treatment, reporting a sensitivity of 100% (95% CI 79.6-100) and a specificity of 98.9% (95% CI 94.3-99.8). Discussion: UBTs using 25 and 15 mg of 13 C-urea were both accurate in the diagnosis of H pylori infection in untreated patients.13 C-UBT 15 mg was also accurate for follow up of patients after treatment.

Accuracy of a new ultrafast rapid urease test to diagnose Helicobacter pylori infection in 1000 consecutive dyspeptic patients

“…The accuracy of this urea breath test has been validated in our laboratory and has a sensitivity and specificity values of 94.7% and 95.7% respectively. 10 …”

An optimized13C-urea breath test for the diagnosis ofH pyloriinfection

“…From each study, the protocol with the best diagnostic performance was selected . Of these, 12 (30%) yielded sensitivities and specificities of 100% [33,37,43,45,47,56,61,63,65,[67][68][69] . Based on the results after reviewing the literature, the present study introduced several variations to simplify even further the technique and make it more cost-efficient, without compromising the high standards of sensitivity, specificity, positive and negative predictive values of the test.…”

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

“…Nonetheless, powdered orange juice had low cost, long expiration date, and stability. Citric acid solution instead of juice showed high sensitivity (89.1%-100%) and specificity (100%) with low concentrations of 10 to 25 mg 13 C-urea solution (8) . Conversely, exam performed with 25 mg 13 C-urea solution in orange juice had lower sensitivity and specificity, and was not recommended for the clinical setting in our country (5) .…”