title: Evaluation of a stool antigen test using a mAb for native catalase for diagnosis of Helicobacter pylori infection in children and adults.
abstract: 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.
authors.affiliation: Department of General Medicine and Community Health Science, Hyogo College of Medicine, Sasayama, Japan.
authors.forename: Masumi
authors.initials: M
authors.lastname: Okuda
authors.affiliation: Department of Infectious Diseases, Kyorin University School of Medicine, Mitaka, Japan.
authors.forename: Takako
authors.initials: T
authors.lastname: Osaki
authors.affiliation: Department of Public Health, Aichi Medical University School of Medicine, Nagakute, Japan.
authors.forename: Shogo
authors.initials: S
authors.lastname: Kikuchi
authors.affiliation: Department of Public Health, Aichi Medical University School of Medicine, Nagakute, Japan.
authors.forename: Junko
authors.initials: J
authors.lastname: Ueda
authors.affiliation: Department of Public Health, Aichi Medical University School of Medicine, Nagakute, Japan.
authors.forename: Yingsong
authors.initials: Y
authors.lastname: Lin
authors.affiliation: Department of Infectious Diseases, Kyorin University School of Medicine, Mitaka, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Yonezawa
authors.affiliation: Department of General Medicine and Community Health Science, Hyogo College of Medicine, Sasayama, Japan.
authors.forename: Kohei
authors.initials: K
authors.lastname: Maekawa
authors.affiliation: Department of Infectious Diseases, Kyorin University School of Medicine, Mitaka, Japan.
authors.forename: Fuhito
authors.initials: F
authors.lastname: Hojo
authors.affiliation: Department of Infectious Diseases, Kyorin University School of Medicine, Mitaka, Japan.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Kamiya
authors.affiliation: Department of General Medicine and Community Health Science, Hyogo College of Medicine, Sasayama, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Fukuda
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial; D000911:Antibodies, Monoclonal; D000942:Antigens, Bacterial / Q000032:analysis; D002374:Catalase / Q000032:analysis*; D002648:Child; D002675:Child, Preschool; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005243:Feces / Q000737:chemistry*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000201:enzymology*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007223:Infant; D007231:Infant, Newborn; D007564:Japan; D008297:Male; D060888:Real-Time Polymerase Chain Reaction; D012680:Sensitivity and Specificity
chemical_list: D000907:Antibodies, Bacterial; D000911:Antibodies, Monoclonal; D000942:Antigens, Bacterial; D002374:Catalase