The stool antigen test for detection of Helicobacter pylori after eradication therapy

Ann Intern Med. 2002 Feb 19;136(4):280-7. doi: 10.7326/0003-4819-136-4-200202190-00007.

Abstract

Background: Current noninvasive tests to confirm the eradication of Helicobacter pylori must be performed 4 weeks or more after eradication therapy is completed.

Objective: To determine whether the stool antigen test, a relatively new noninvasive test for H. pylori, administered at various times after eradication therapy correctly identifies persons with persistent H. pylori infection.

Design: Prospective blinded study.

Setting: Six clinical centers in the United States and Europe.

Patients: 84 H. pylori --infected patients undergoing endoscopy for upper abdominal symptoms.

Measurements: At baseline and on day 35 after the completion of triple eradication therapy, all patients underwent endoscopy with histologic examination, rapid urease test and culture, urea breath test, and a stool antigen test. The stool antigen test was also performed on days 3, 7, 15, 21, 28, and 35 after completion of therapy.

Results: Compared with the gold-standard endoscopic tests on day 35 after antimicrobial therapy, the urea breath test had a sensitivity of 94% (95% CI, 71% to 100%) and a specificity of 100% (CI, 94% to 100%). The stool antigen test had a sensitivity of 94% (CI, 71% to 100%) and a specificity of 97% (CI, 89% to 100%). On day 7 after treatment, the stool antigen test was predictive of eradication (positive predictive value, 100% [CI, 69% to 100%]; negative predictive value, 91% [CI, 82% to 97%]).

Conclusion: A positive result on the stool antigen test 7 days after completion of therapy identifies patients in whom eradication of H. pylori was unsuccessful.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / therapeutic use
  • Antigens, Bacterial / analysis*
  • Breath Tests
  • Drug Therapy, Combination
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Feces / microbiology*
  • Female
  • Gastritis / drug therapy
  • Gastritis / microbiology*
  • Helicobacter Infections / drug therapy
  • Helicobacter Infections / microbiology*
  • Helicobacter pylori / isolation & purification*
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Sensitivity and Specificity
  • Single-Blind Method

Substances

  • Anti-Bacterial Agents
  • Antigens, Bacterial