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

Abstract

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