Diagnostic accuracy of a new non-invasive enzyme immunoassay for detecting Helicobacter pylori in stools after eradication therapy

Aliment Pharmacol Ther. 2000 May;14(5):611-4. doi: 10.1046/j.1365-2036.2000.00736.x.


Background: Helicobacter pylori eradication therapy has been commonly performed for patients with peptic ulcer. An inexpensive, reliable, non-invasive test would be useful for evaluation of the effectiveness of eradication therapy.

Aim: To evaluate the diagnostic potential of a new non-invasive enzyme immunoassay (HpSA) for H. pylori antigen in stools.

Methods: A total of 112 peptic ulcer patients with H. pylori infection (82 male, 30 female; age range 22-81 years, mean 54 years) received a course of eradication therapy. Four weeks after the end of the therapy, stool samples were collected from all patients and tested using the HpSA. The diagnostic accuracy of the HpSA EIA was evaluated in comparison with the results of a 13C-urea breath test.

Results: The diagnostic sensitivity of HpSA EIA after eradication therapy was 90%, the specificity 98%, the positive predictive value 82% and the negative predictive value 99%.

Conclusion: The HpSA stool test is potentially useful for the diagnosis of H. pylori infection 4 weeks after the end of eradication therapy.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antigens, Bacterial / analysis
  • Diagnosis, Differential
  • Feces / microbiology
  • Female
  • Helicobacter Infections / diagnosis*
  • Helicobacter Infections / drug therapy
  • Helicobacter pylori* / immunology
  • Helicobacter pylori* / isolation & purification
  • Humans
  • Immunoenzyme Techniques / methods
  • Immunoenzyme Techniques / standards
  • Male
  • Middle Aged
  • Peptic Ulcer / drug therapy
  • Peptic Ulcer / microbiology
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Time Factors


  • Antigens, Bacterial