Clinical validation of the Helikit: a 13C urea breath test used for the diagnosis of Helicobacter pylori infection.

Objective: To assess the clinical performance of the Helikit, a 13C urea breath test, in the diagnosis of Helicobacter pylori infection.

Methods: A total of 205 participants were assessed in Canada and Korea for H. pylori infection status by endoscopy, or a combination of IgG ELISA and CLO test, as well as by the Helikit. The Helikit contains 75 mg of 13C urea as well as citric acid, flavor enhancers and stabilizers in a single plastic cup. The powder is dissolved in 75 mL of water for oral administration. No extra mixing or dilution steps are required.

Results: Using the biopsy-derived data as the gold standard the Helikit displayed a clinical sensitivity of 93.5% (95% confidence interval 88.5 to 98.5%) and a clinical specificity of 97.3% (94.3 to 100%). An overall diagnostic efficiency of 95.6% (92.8 to 98.4%) was obtained. No statistically significant difference in the performance characteristics was found between Korea and Canada. No significant adverse events were noted.

Conclusions: The Helikit offers an easy, safe and accurate approach to the diagnosis of H. pylori infection.