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.