Rapid Communication
Copyright ©2005 Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 14, 2005; 11(46): 7340-7344
Published online Dec 14, 2005. doi: 10.3748/wjg.v11.i46.7340
Stool antigen tests in the diagnosis of Helicobacter pylori infection before and after eradication therapy
Lea Veijola, Eveliina Myllyluoma, Riitta Korpela, Hilpi Rautelin
Lea Veijola, Department of Bacteriology and Immunology, Haartman Institute, University of Helsinki, and Malmi Hospital, Helsinki, Finland
Eveliina Myllyluoma, Institute of Biomedicine, Pharmacology, University of Helsinki, and Foundation for Nutrition Research, Helsinki, Finland
Riitta Korpela, Institute of Biomedicine, Pharmacology, University of Helsinki, and Valio Ltd. Research Centre, Helsinki, Finland
Hilpi Rautelin, Department of Bacteriology and Immunology, Haartman Institute, University of Helsinki, and HUSLAB, Helsinki University Central Hospital Laboratory, Helsinki, Finland
Author contributions: All authors contributed equally to the work.
Supported by the Valio Research Centre and by grants from City of Helsinki, Terke 2004-368 (Lea Veijola) and Foundation for Nutrition Research, No. 0116610-9 (Eveliina Myllyluoma)
Correspondence to: Dr. Lea Veijola, Department of Bacteriology and Immunology, Haartman Institute, University of Helsinki, PO Box 21, Fin-00014 Helsinki, Finland. lea.veijola@helsinki.fi.
Telephone: +358-9-19126716 Fax: +358-9-19126382
Received: February 25, 2005
Revised: April 13, 2005
Accepted: April 18, 2005
Published online: December 14, 2005
Abstract

AIM: To evaluate two enzyme immunoassay-based stool antigen tests, Premier Platinum HpSA and Amplified IDEIA HpStAR, and one rapid test, ImmunoCard STAT! HpSA, in the primary diagnosis of Helicobacter pylori (H pylori) infection and after eradication therapy.

METHODS: Altogether 1 574 adult subjects were screened with a whole-blood H pylori antibody test and positive results were confirmed with locally validated serology and 13C-urea breath test. All 185 subjects, confirmed to be H pylori positive, and 97 H pylori-negative individuals, randomly selected from the screened study population and with negative results in serology and UBT, were enrolled. After eradication therapy the results of 182 subjects were assessed.

RESULTS: At baseline, the sensitivity of HpSA and HpStAR was 91.9% and 96.2%, respectively, and specificity was 95.9% for both tests. ImmunoCard had sensitivity of 93.0% but specificity of only 88.7%. After eradication therapy, HpSA and HpStAR had sensitivity of 81.3% and 100%, and specificity of 97.0% and 97.6%, respectively. ImmunoCard had sensitivity of 93.8% and specificity of 97.0%. HpSA, HpStAR, and ImmunoCard had PPV 77%, 80%, and 75%, and NPV 98%, 100%, and 99%, respectively.

CONCLUSION: In primary diagnosis, the EIA-based tests performed well. After eradication therapy, negative results were highly accurate for all the three tests. HpStAR had the best overall performance.

Keywords: Diagnosis; Feces; Helicobacter pylori; Therapy