title: Prospective comparison of commercially available rapid urease tests for the diagnosis of Helicobacter pylori.
abstract: BACKGROUND
  Rapid urease testing is the initial endoscopic test of choice for the diagnosis of Helicobacter pylori. Determination of the relative diagnostic yields and times to a positive test for the different rapid urease tests is important for endoscopists. We compared three commercially available tests using histologic examination and culture as a gold standard.
  
  
  METHODS
  Patients undergoing upper endoscopy had six biopsy specimens taken from the antrum and six from the body with a large-channel biopsy forceps. Each set of six specimens was divided as follows: one each for CLOtest, Hpfast, and Pyloritek rapid urease tests; one for culture; and two for histologic examination (H&E, Genta). All tests were read every 15 minutes for 1 hour; the final reading for Pyloritek was at 1 hour. CLOtest and Hpfast were also read at 4 hours and 24 hours.
  
  
  RESULTS
  One hundred seventy-three sets of biopsy specimens from 87 patients were evaluated; 98 (57%) of the 173 sets were positive for H. pylori by histologic examination and/or culture. The mean and median times to a positive test were significantly less for Pyloritek (0.5 +/- 0.02 hour and 0.5 hour) than for CLOtest (2.0 +/- 0.6 hour and 0.75 hour) or Hpfast (2.2 +/- 0.6 hour and 0.5 hour). The sensitivities at the final readings were similar among the three tests (CLOtest: 93%; Hpfast: 88%; Pyloritek: 89%), but sensitivities at 1 hour were significantly better for Pyloritek (89%) than for CLOtest (71%) or Hpfast (66%). At 4 hours, sensitivities for CLOtest and Hpfast improved significantly and were not significantly different from those of Pyloritek. Specificities were 99% to 100% at all times for all three tests.
  
  
  CONCLUSIONS
  The three rapid urease tests, CLOtest, Hpfast, and Pyloritek, provide comparable results, with sensitivities around 90% and specificities around 100%. The Pyloritek becomes positive more rapidly than the CLOtest or Hpfast. If a reading is desired within 1 hour, the Pyloritek provides a greater sensitivity than the CLOtest or Hpfast without any sacrifice in specificity.
authors.affiliation: University of Southern California School of Medicine, Los Angeles 90033, USA.
authors.forename: L
authors.initials: L
authors.lastname: Laine
authors.forename: D
authors.initials: D
authors.lastname: Lewin
authors.forename: W
authors.initials: W
authors.lastname: Naritoku
authors.forename: R
authors.initials: R
authors.lastname: Estrada
authors.forename: H
authors.initials: H
authors.lastname: Cohen
mesh_terms: D001431:Bacteriological Techniques; D001706:Biopsy; D016099:Endoscopy, Gastrointestinal; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000201:enzymology* / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011706:Pyloric Antrum / Q000382:microbiology / Q000473:pathology; D012680:Sensitivity and Specificity; D014510:Urease / Q000032:analysis*
chemical_list: D014510:Urease