title: 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.
  
  
  OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
authors: Department of Medicine, Unit of Gastroenterology and Hepatology, Karolinska Hospital, Karolinska Institutet, Sweden.
authors: Olga
authors: O
authors: Hegedus
authors: Johan
authors: J
authors: Rydén
authors: Ann-Sofie
authors: AS
authors: Rehnberg
authors: Stefan
authors: S
authors: Nilsson
authors: Per M
authors: PM
authors: Hellström
mesh_terms: D001944:Breath Tests / Q000379:methods; D002250:Carbon Radioisotopes; D016481:Helicobacter Infections / Q000175:diagnosis; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D012680:Sensitivity and Specificity; D014508:Urea
chemical_list: D002250:Carbon Radioisotopes; D014508:Urea