title: Accuracy of four commercially available serologic tests, including two office-based tests and a commercially available 13C urea breath test, for diagnosis of Helicobacter pylori.
abstract: BACKGROUND
  Diagnosis of H. pylori infection may be made by endoscopic (invasive) tests, or by nonendoscopic (noninvasive) tests. Our aim was to evaluate recently available nonendoscopic tests, including two office-based serologic tests and a commercially available 13C urea breath test.
  
  
  METHODS
  Gastric biopsy specimens (for culture and stain) from 178 patients (mean age 46 +/- 13.3 years, 79 men and 99 women), none of whom had received anti-H. pylori therapy, were tested for H. pylori infection. These tests were compared against two commercial serum IgG antibody immunoassays (Biowhittaker's Pyloristat, and Quidel), 2 office-based serum qualitative IgG antibody tests (FlexSure HP, and QuickVue One-Step), the Meretek 13C urea breath test, and the CLOtest (a biopsy urease test).
  
  
  RESULTS
  The breath test (n = 147) had the best accuracy (96%) of the noninvasive tests studied. The serologic tests had similar accuracy to one another (84%-90%). The major drawback of the serologic tests was suboptimal specificity (75%-87%). Diagnosis of H. pylori based on the two office-based tests were not significantly different compared to the quantitative IgG antibody tests. The CLOtest had an accuracy of 97%.
  
  
  CONCLUSIONS
  The Meretek 13C urea breath test is an excellent test, but is considerably more expensive than serologic tests. The FlexSure HP and the QuickVue One-Step office-based qualitative IgG serologic antibody tests gave similar results to laboratory based quantitative antibody tests, and are acceptable for initial diagnosis of H. pylori infection. The advantages of the office-based tests are low cost, simplicity, and immediacy of results.
authors.affiliation: Division of Gastrointestinal and Liver disease, USC School of Medicine, Los Angeles, CA 90033, USA.
authors.forename: H
authors.initials: H
authors.lastname: Cohen
authors.forename: S
authors.initials: S
authors.lastname: Rose
authors.forename: D N
authors.initials: DN
authors.lastname: Lewin
authors.forename: B
authors.initials: B
authors.lastname: Retama
authors.forename: W
authors.initials: W
authors.lastname: Naritoku
authors.forename: C
authors.initials: C
authors.lastname: Johnson
authors.forename: L
authors.initials: L
authors.lastname: Bautista
authors.forename: H
authors.initials: H
authors.lastname: Crowe
authors.forename: A
authors.initials: A
authors.lastname: Pronovost
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy; D001944:Breath Tests; D002247:Carbon Isotopes; D016145:Endoscopy, Digestive System; D005260:Female; D016481:Helicobacter Infections / Q000097:blood / Q000175:diagnosis* / Q000382:microbiology / Q000473:pathology; D016480:Helicobacter pylori / Q000201:enzymology / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D012698:Serologic Tests; D013270:Stomach / Q000382:microbiology / Q000473:pathology; D014510:Urease / Q000378:metabolism
chemical_list: D002247:Carbon Isotopes; D011933:Reagent Kits, Diagnostic; D014510:Urease