title: Noninvasive tests as a substitute for histology in the diagnosis of Helicobacter pylori infection.
abstract: BACKGROUND
  Rapid urease tests for Helicobacter pylori have a sensitivity of 80% to 90%. Therefore histologic examination of gastric biopsies is recommended as a "backup" diagnostic test in rapid urease test-negative patients. However, noninvasive tests (urea breath test, serology, whole blood antibody tests) may provide a more rapid diagnosis and be less expensive but offer similar accuracy.
  
  
  METHODS
  Sixty-seven patients (no prior treatment for H pylori, no proton pump inhibitors, antibiotics, or bismuth within 4 weeks) undergoing endoscopy for evaluation of dyspepsia symptoms and testing rapid urease test-negative by antral biopsy were enrolled. All had the following tests: gastric biopsies (2 antral, 1 fundus; H&E and Alcian Yellow stain) examined for gastritis and H pylori; (13)C-UBT; capillary blood for whole blood rapid antibody tests: FlexSure HP, QuickVue, AccuStat, and Stat-Simple Pylori; serum for FlexSure HP; HM-CAP enzyme-linked immunoassay. H pylori infection was diagnosed (reference standard) if chronic gastritis was present on histology and at least 2 of the 3 following tests were positive: urea breath test, H pylori organisms unequivocally demonstrated in biopsies on special stain, and/or enzyme-linked immunoassay. The test and treatment costs per patient were calculated.
  
  
  RESULTS
  Of 67 patients with a negative rapid urease test, 4 were positive for H pylori. None had active peptic ulcer disease. Histology only identified 1 patient with organisms visible on special stain. Using chronic active gastritis (neutrophilic and mononuclear infiltrate) as a diagnostic criterion for H pylori, 6 patients would have been judged positive. However, only 2 of these were truly positive by the reference standard (positive predictive value 33%). Negative predictive value for presence of organisms and chronic active gastritis was 95% and 97%, respectively. All of the noninvasive tests identified all 4 truly positive patients correctly. Urea breath test and FlexSure whole blood assay yielded a substantial number of false-positive results (positive predictive value 31% and 36%, respectively); positive predictive value for the other tests ranged from 50% to 80%. All tests except histology had a negative predictive value of 100%. Histology was the most costly test (p < 0. 001 compared with all other tests), followed by urea breath test and HM-CAP serology (p < 0.001 compared with all rapid antibody tests).
  
  
  CONCLUSIONS
  Whole blood or serum antibody testing is a rapid, accurate, and cost-effective means for establishing H pylori status in rapid urease test-negative patients. Whole blood or serology rapid antibody testing should substitute for histology when the patient has not been previously treated for H pylori.
authors.affiliation: Division of Gastroenterology, Portland VA Medical Center and Oregon Health Sciences University, OR 97201, USA.
authors.forename: M
authors.initials: M
authors.lastname: Hahn
authors.forename: M B
authors.initials: MB
authors.lastname: Fennerty
authors.forename: C L
authors.initials: CL
authors.lastname: Corless
authors.forename: N
authors.initials: N
authors.lastname: Magaret
authors.forename: D A
authors.initials: DA
authors.lastname: Lieberman
authors.forename: D O
authors.initials: DO
authors.lastname: Faigel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000032:analysis; D001707:Biopsy, Needle; D001944:Breath Tests; D003362:Cost-Benefit Analysis; D005260:Female; D005756:Gastritis / Q000382:microbiology* / Q000473:pathology*; D005773:Gastroscopy; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000473:pathology; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000191:economics; D008297:Male; D008875:Middle Aged; D011336:Probability; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D014508:Urea / Q000032:analysis*
chemical_list: D000907:Antibodies, Bacterial; D014508:Urea