title: A multicentre evaluation of the laser assisted ratio analyser (LARA): a novel device for measurement of 13CO2 in the 13C-urea breath test for the detection of Helicobacter pylori infection.
abstract: BACKGROUND
  The laser assisted ratio analyser (LARA) was developed as a novel device to measure 13CO2 in the urea breath test for the detection of H. pylori infection. The analyser was tested in a prospective multicentre study in 444 patients in North America (Phase 1) followed by second study involving 160 patients (Phase 2).
  
  
  METHODS
  Patients undergoing endoscopy for clinical indications had antral and gastric biopsies taken for histological examination, culture and CLO test. One hour after endoscopy, a baseline breath sample was obtained, 100 mg of 13C-urea were ingested and breath samples were obtained at 30 and 60 min post ingestion. Data obtained with the LARA were compared with the results of culture, rapid urease testing and central pathology in two different combinations {reference standards}. The study was conducted in two phases: in Phase 2, a modification was made to the LARA that improved the removal of water vapour from the breath sample.
  
  
  RESULTS
  In Phase I, data from 331 patients were analysed using a cut off of (delta) 7.8 +/- 0.8, the sensitivity of the method was 91.7% and the specificity was 86.5%, using the reference standard of 2 of 3 tests (CLO, culture or histology) being positive. Positive and negative predictive values were, respectively, 85.2% and 92.5%. In Phase 2 of the study, 160 patients were enrolled and 141 patients were analysed using the same standards. We used the same reference standards but with a cut off of (delta) 6.1 +/- 0.6. The sensitivity and specificity increased to 96.8% and 98.6%, respectively. Positive and negative predictive values were, respectively, 98.4% and 97.3%. The detection rates for H. pylori were similar in patients with peptic ulcer or H. pylori associated gastritis.
  
  
  CONCLUSIONS
  The LARA provides an accurate non-invasive means of detecting 13CO2 in the 13C-urea breath test for H. pylori in a multicentre clinical environment that compares well with invasive 'gold standard' methods.
authors.affiliation: St Elizabeth's Hospital Medical Center of Boston, Brighton MA 02135, USA.
authors.forename: D R
authors.initials: DR
authors.lastname: Cave
authors.forename: S V
authors.initials: SV
authors.lastname: Zanten
authors.forename: E
authors.initials: E
authors.lastname: Carter
authors.forename: E F
authors.initials: EF
authors.lastname: Halpern
authors.forename: S
authors.initials: S
authors.lastname: Klein
authors.forename: C
authors.initials: C
authors.lastname: Prather
authors.forename: M
authors.initials: M
authors.lastname: Stolte
authors.forename: L
authors.initials: L
authors.lastname: Laine
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001944:Breath Tests; D002245:Carbon Dioxide / Q000032:analysis*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori; D006801:Humans; D007834:Lasers; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014508:Urea / Q000378:metabolism*
chemical_list: D002245:Carbon Dioxide; D014508:Urea