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Evaluation of a stool antigen test using a mAb for native catalase for diagnosis of Helicobacter pylori infection in children and adults.

  • Okuda, Masumi1
  • Osaki, Takako2
  • Kikuchi, Shogo3
  • Ueda, Junko3
  • Lin, Yingsong3
  • Yonezawa, Hideo2
  • Maekawa, Kohei1
  • Hojo, Fuhito2
  • Kamiya, Shigeru4
  • Fukuda, Yoshihiro1
  • 1 Department of General Medicine and Community Health Science, Hyogo College of Medicine, Sasayama, Japan. , (Japan)
  • 2 Department of Infectious Diseases, Kyorin University School of Medicine, Mitaka, Japan. , (Japan)
  • 3 Department of Public Health, Aichi Medical University School of Medicine, Nagakute, Japan. , (Japan)
  • 4 Department of Infectious Diseases, Kyorin University School of Medicine, Mitaka, Japan [email protected] , (Japan)
Published Article
Journal of Medical Microbiology
Microbiology Society
Publication Date
Dec 01, 2014
Pt 12
DOI: 10.1099/jmm.0.077370-0
PMID: 25332372


Non-invasive diagnosis of Helicobacter pylori infection is important not only for screening of infection but also for epidemiological studies. Stool antigen tests are non-invasive and are convenient to identify H. pylori infection, particularly in children. We evaluated the stool antigen test, which uses a mAb for native catalase of H. pylori developed in Japan. A total of 151 stool samples were collected from participants (52 children and 99 adults) of the Sasayama Cohort Study and stored between -30 and -80 °C. The stool antigen test used was Testmate pylori antigen (TPAg), and was performed according to the manufacturer's instructions. Furthermore, we conducted a quantitative real-time PCR test and compared the PCR results with those of the TPAg test. When compared with the results in real-time PCR, the sensitivity of TPAg was 89.5 % overall, 82.7 % for children and 92.4 % for adults, and the specificity was 100 %. The accuracy was 93.4 % overall, 90.4 % for children and 94.9 % for adults, and there was no significant difference in the accuracy of TPAg between children and adults. Five of 28 children (18 %) and five of 38 adults (13 %) were PCR positive with negative TPAg results. Four of five children with positive PCR and negative TPAg results were given a (13)C-urea breath test and all four children tested negative. No significant correlation was observed between the TPAg results and DNA numbers of H. pylori in faeces among children or adults. A stool antigen test (TPAg) using a mAb for native catalase is useful for diagnosis of H. pylori in children and adults. Additionally, this test has particularly high specificity.

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