Validated accuracy of a novel urea breath test for rapid Helicobacter pylori detection and in-office analysis

Background A novel C-14-urea breath test (UBT) was developed to detect the presence of Helicobacter pylori by bench analysis in off ice, enabling the practitioner to readily reveal H. pylori infection. Aim To validate the novel UBT (Heliprobe) versus conventional UBT. Methods Pretreatment (n = 203) and post-treatment (n = 147) detection of H. pylori. Additional tests with encapsulated C-14-urea (n = 37) were validated. After intake of liquid or encapsulated C-14-urea, exhaled (CO2)-C-14 in breath was trapped in benzethoniumhydroxide/ethanol, or adsorbed to LiOH-soaked pads on a dry cover surface (Heliprobe BreathCard). The amount of adsorbed C-14 Was detected using a beta-scintillator or two Geiger-Muller counters operating in parallel (Heliprobe Analyzer). Results For pretreatment detection, we found full concordance between the UBTs, with 100% sensitivity and specificity (Cl 95-100% and 97-100%, respectively) and strong agreement (r = 0.80, Cl 0.75-0.85; K = 1, Cl 0.86-1.14; P < 0.0001). Similarly, for post-treatment follow-up detection, sensitivity and specificity were 100% (Cl 85-100% and 97-100%, respectively) with significant agreement (r = 0.48, Cl 0.34-0.59; kappa = 1, Cl 0.84-1.16; P < 0.0001). The use of encapsulated C-14-urea did not change agreement between the tests. Sensitivity and specificity were 100% (Cl 72-100% and 87-100%, respectively) with strong agreement between the tests (r = 0.71, Cl 0.50-0.84; kappa = 1, Cl 0.68-1.32; P < 0.0001). Conclusion The novel Heliprobe UBT, with either liquid or encapsulated C-14-urea, seems equi-efficacious to conventional UBT in fulfilling its role as the non-invasive gold standard for detection of H. pylori.