The Stool Antigen Test for Detection of Helicobacter pylori after Eradication Therapy

19 February 2002 | Volume 136 Issue 4 | Pages 280-287

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.

Editors' Notes Context Standard treatment regimens do not eradicate infection in approximately 10% to 20% of people with ulcers or gastritis caused by Helicobacter pylori. Symptoms do not reliably identify patients who have persistent infection despite treatment. Although positive results on a urea breath test done 4 weeks after treatment reliably identify persistent infection, a noninvasive test that detects successful eradication earlier would be useful. Contribution This multicenter study shows that a positive finding on a stool antigen test done as early as 1 week after treatment identifies about 95% (range, 70% to 100%) of cases of persistent infection. Generalization Cautions Findings are from patients with dyspepsia who were referred for endoscopy; 20% of patients were still infected at 1 month despite eradication therapy. –The Editors

 

Author and Article Information

From University of Bologna, Bologna, and Policlinico Gemelli, Rome, Italy; University of Wisconsin Medical School, Milwaukee, Wisconsin; University of Amsterdam, Amsterdam, the Netherlands; Hospital de Pulido Valente, Lisbon, Portugal; and Hospital de la Princesa, Madrid, Spain.

Grant Support: Stool testing kits were provided by Meridian Diagnostics, Inc.

Requests for Single Reprints: Dino Vaira, MD, Department of Internal Medicine and Gastroenterology, S. Orsola Hospital, via Massarenti 9, 40138 Bologna, Italy; e-mail, vairadin{at}med.unibo.it.

Current Author Addresses: Drs. Vaira, Menegatti, Ricci, Gatta, and Miglioli: Department of Internal Medicine and Gastroenterology, S. Orsola Hospital, via Massarenti 9, 40138 Bologna, Italy.

Dr. Vakil: University of Wisconsin Medical School, Sinai Samaritan Medical School, 945 North 12th Street, Room 4040, Milwaukee, WI 53233.

Drs. van't Hoff, van der Ende, van der Hulst, and Tytgat: Academisch Ziekenhuis bij de Universiteit van Amsterdam, Academisch Medisch Centrum, Amsterdam, the Netherlands 1100DE.

Drs. Gasbarrini and Anti: Policlinico Gemelli, via Pineta Sacchetti, 00168 Rome, Italy.

Drs. Quina and Duarte: Servico Universitario de Medicina Interna e Gastroenterologia, Hospital de Pulido Valente, Alameda das Linhas de Torres 117, P-1750 Lisboa, Portugal.

Dr. Pajares Garcia and Gisbert: Hospitales Universitarios, La Princesa-Niño Jesus-Santa Cristina, Diego de Leon, 62, 28006 Madrid, Spain.

Author Contributions: Conception and design: D. Vaira, N. Vakil, M. Menegatti, B. van't Hoff, C. Ricci, L. Gatta, G. Gasbarrini, M. Quina, J. Pajares Garcia, A. van der Ende, R. van der Hulst, M. Anti, C. Duarte, J.P. Gisbert, M. Miglioli, G. Tytgat.

Analysis and interpretation of the data: D. Vaira, N. Vakil, M. Menegatti, B. van't Hoff, C. Ricci, L. Gatta, A. van der Ende, R. van der Hulst, C. Duarte, J.P. Gisbert, G. Tytgat.

Drafting of the article: D. Vaira, N. Vakil, M. Menegatti, B. van't Hoff, C. Ricci, L. Gatta, A. van der Ende, R. van der Hulst, C. Duarte, J.P. Gisbert, G. Tytgat.

Critical revision of the article for important intellectual content: D. Vaira, N. Vakil, M. Menegatti, C. Ricci, L. Gatta, G. Gasbarrini, M. Quina, J. Pajares Garcia, R. van der Hulst, M. Anti, C. Duarte, M. Miglioli, G. Tytgat.

Final approval of the article: D. Vaira, N. Vakil, M. Menegatti, B. van't Hoff, C. Ricci, L. Gatta, G. Gasbarrini, J. Pajares Garcia, A. van der Ende, R. van der Hulst, M. Anti, C. Duarte, J.P. Gisbert, G. Tytgat.

Provision of study materials or patients: D. Vaira, B. van't Hoff, M. Miglioli.

Statistical expertise: N. Vakil.

Collection and assembly of data: D. Vaira, N. Vakil, B. van't Hoff, C. Ricci, L. Gatta, C. Duarte, J.P. Gisbert.

Read all Rapid Responses

Sequential therapy: Minimizing risk and maximizing outcome

Dino Vaira, et al.

Annals Online, 7 May 2007 [Full text]